Biosimilars/Research

Biosimilars for skin conditions safe and effective

Biosimilars/Research | Posted 14/05/2021

Two recently published articles [1, 2] assessing the use of biosimilars for the long-term skin conditions psoriasis and hidradenitis suppurativa indicate that biosimilar treatments are equally as effective as the originator, demonstrating similar drug retention and clinical response rates, respectively.

Study supports advanced IV preparation and storage of ABP 215

Biosimilars/Research | Posted 07/05/2021

The first approved bevacizumab biosimilar, ABP 215 (Mvasi), can be prepared in bag, over a month prior to being used to treat patients via intravenous (IV) infusion, shows a study published in GaBI Journal [1]. The study reveals that ABP 215 retains physicochemical stability after dilution and storage, which can ease the process of drug administration in clinical settings.

A positive outlook for the US biosimilars market

Biosimilars/Research | Posted 30/04/2021

The US is keeping pace with the European pioneers of biosimilars approvals, reveals an article published in GaBI Journal [1].

Expanding access to trastuzumab biological treatments

Biosimilars/Research | Posted 30/04/2021

The anti-human epidermal growth factor receptor 2 (HER2) monoclonal antibody trastuzumab is indicated for treatment of HER2-positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Often used in conjunction with chemotherapy, trastuzumab was originally approved as an intravenous (IV) formulation. Subcutaneous (SC) formulations were more recently approved for HER2-positive breast cancer in 2013 (Europe) [1] and 2019 (US) [2].

CADTH summarizes evidence on switching to etanercept biosimilars

Biosimilars/Research | Posted 23/04/2021

The Canadian Coordinating Office for Health Technology Assessment (CCOHTA), known today as CADTH, is an independent, not-for-profit organization responsible for providing Canada’s healthcare decision-makers with objective evidence to help make informed decisions about the optimal use of drugs and medical devices in our healthcare system.

Relieving the economic burden on EU healthcare budgets: spotlight on IV trastuzumab and rituximab biosimilars

Biosimilars/Research | Posted 23/04/2021

In an ageing society with increasing medical need, biological treatments have played a key role in reforming the management of cancer, autoimmune and certain preventable diseases. Yet, biological treatments impose a significant financial burden on the healthcare system and healthcare payers.

Characteristics associated with biosimilar use in Medicare recipients

Biosimilars/Research | Posted 16/04/2021

What patient, physician and practice characteristics are associated with biosimilar usage for the biologicals filgrastim and infliximab was a question asked by researchers from the US [1].

Biosimilars in the treatment of psoriasis

Biosimilars/Research | Posted 16/04/2021

A recent paper by Spanish dermatologists reviews the principles of biosimilarity and equivalence trials that have led to the approval of the available adalimumab biosimilars [1]. Given the current sophistication of the analytical processes, the need to include therapeutic equivalence trials for some drug classes might be eventually waived, but they are currently standard. Equivalence trials are designed to establish that the efficacy and safety of the biosimilar are similar to those of the reference biological, with a predetermined margin of equivalence that in psoriasis ranges from ±14% to ±18%. Lower margins would imply potentially unaffordable sizes of treatment groups. The primary endpoint of the study and the timing of the determination may or may not be the same as those used in the pivotal trials of the reference biological, but the number of patients included is intentionally lower; the statistical design of equivalence trials is currently the subject of active research. In many equivalence studies, biosimilars obtain response rates higher than those reported in the pivotal studies for the originator, probably because of the absence of a placebo arm, which would tend to raise researchers’ and patients’ efficacy expectations.

Adalimumab biosimilar FKB327 causes less pain than originator

Biosimilars/Research | Posted 09/04/2021

Fujifilm Kyowa Kirin Biologics’ adalimumab biosimilar FKB327 has been found to cause less injection-site pain compared to the reference product, according to data from more than 1,001 subjects and patients [1].

Biosimilars regulation, clinical trials, approval and adverse events in Malaysia

Biosimilars/Research | Posted 09/04/2021

Compared to chemical drugs, biologicals are more expensive because of their complicated manufacturing processes. Patients often use biologicals for long-term therapy, which may exert huge budgetary pressure on healthcare systems. One alternative solution to address this issue is to use biosimilars that are similar to the originator biologicals, with no clinical differences in terms of quality, efficacy, safety and immunogenicity. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) approved the country’s first biosimilar, somatropin, in 2010. Since then, the number of approved biosimilars and clinical trials on biosimilars continue to rise. With increased use of biosimilars, an increased number of adverse events (AEs) is expected because like any other biological, they may elicit immunogenic reactions.

Etanercept biosimilar injection pen, YLB113, convenient and easy to use

Biosimilars/Research | Posted 02/04/2021

A study of an injection pen formulation of the etanercept biosimilar YLB113, which is manufactured by the Japanese firm YL Biologics, finds it to be convenient and easy to use and convenient among patients with rheumatoid arthritis [1].

Samsung Bioepis and Eden Biologics announce new biosimilars trials

Biosimilars/Research | Posted 02/04/2021

In early 2021, Samsung Bioepic and Eden Biologics announced advances in the clinical trials of their respective ustekinumab and denosumab biosimilars.

Public health impact of using biosimilars and relevance of automated follow-up

Biosimilars/Research | Posted 26/03/2021

Biological reference drugs and biosimilars have highly complex structures. Biosimilars need to demonstrate their biosimilarity during their development but unpredictable variations can remain, such as micro-heterogeneity. The healthcare community may raise questions regarding the clinical outcomes induced by this micro-heterogeneity. Indeed, unwanted immune reactions may be induced for numerous reasons, including product variations. However, it is challenging to assess these unwanted immune reactions because of the multiplicity of causes and potential delays before any reaction. Moreover, safety assessments, as part of preclinical studies and clinical trials, may be of limited value with respect to immunogenicity assessments because they are performed on a standardized population during a limited period. Real-life data could therefore supplement the assessments of clinical trials by including data on the real-life use of biosimilars, such as switches. Furthermore, real-life data also include any economic incentives to prescribe or use biosimilars.

Pelmeg developed with aid of regulatory reform

Biosimilars/Research | Posted 19/03/2021

The development of Pelmeg, a biosimilar of pegfilgrastim, revealed flexibility in the regulatory guidelines as they were superseded by state-of-the-art science, a study uncovers [1].

Knowledge and perceptions about naming biosimilars in the US

Biosimilars/Research | Posted 19/03/2021

Following the introduction of biosimilars, naming conventions for biologicals have been introduced, in part to support pharmacovigilance.

Infliximab biosimilars for IBD patients: experience from Italy

Biosimilars/Research | Posted 12/03/2021

In the last 20 years, biological drugs have become the mainstream therapy for patients affected by moderately-to-severely active inflammatory bowel disease (IBD), even though they are associated with a significant increase in health-related costs. After the expiry of patents on originator drugs, the advent of antitumour necrosis factor alfa (TNF-α) biosimilars resulted in considerable cost-savings and increased patients’ access to these drugs. After having completed registration trials in rheumatic diseases [1, 2], the infliximab biosimilar CT P13 obtained approval based on a comprehensive comparability exercise, for all other indications, including IBD. Accordingly, physicians started to increasingly prescribe biosimilars for patients with IBD – including those that were both anti-TNF-α naïve and experienced. There is growing evidence that early introduction of biological therapy in IBD is associated with more favourable outcomes in the medium to long term. Keeping that in mind, it follows that the advent of biosimilars has the potential to allow more patients to have access to biological therapy at an earlier stage of disease, which could contribute to prevent disease progression and damage accumulation, with a consequential improvement in patients’ quality of life.

Efficacy and safety of interferon beta-1a (ReciGen) in COVID-19

Biosimilars/Research | Posted 05/03/2021

Since COVID-19, caused by SARS-CoV-2, emerged as a worldwide concern and was declared a pandemic, finding a safe and effective treatment for this disease has been a top priority. Different treatment candidates, including interferon [1], remdesevir [2], tocilizumab [3], and dexamethasone [4] have been investigated in multiple clinical trials.

Improving biosimilar use in clinical practice

Biosimilars/Research | Posted 26/02/2021

Uncertainty about biosimilars and lack of motivation among healthcare providers and patients to use them may have been curbing biosimilar use. Guidance on how to implement biosimilars in clinical practice and how to incentivize stakeholders to use biosimilars may help to realize the benefits offered by biosimilars for healthcare systems and patients.

Improving stakeholder understanding about biosimilars

Biosimilars/Research | Posted 19/02/2021

The arrival of biosimilars provides benefits for healthcare systems and patients by lowering treatment costs and improving patient access to biologicals. Despite these benefits and demonstrated comparability with the reference biological, the use of biosimilars varies across regions and remains limited in some cases. This may be partially due to a lack of knowledge and understanding among healthcare professionals and patients about biosimilars, limiting their willingness to use them.

Interchangeability, naming and pharmacovigilance of biosimilars

Biosimilars/Research | Posted 12/02/2021

Results of a survey was carried out by the World Health Organization (WHO) revealed that challenges still remain when it comes to the regulatory evaluation of biosimilars [1].

Improving the understanding of biosimilars through education

Biosimilars/Research | Posted 12/02/2021

The process of introducing biosimilars into clinical practice is complex and involves many stakeholders. There are different strategies that healthcare systems have adopted to incorporate biosimilars into patient care. Regulators, payers, pharmacists, and physicians need adequate knowledge in order to be effective components of this process. Previous research in the region has shown a high prevalence of lack of understanding and major safety concerns on the use of biosimilars [1].

Understanding and minimizing injection-site pain for biologicals

Biosimilars/Research | Posted 05/02/2021

Biologicals have revolutionized treatment across a range of immune and inflammatory-related diseases and have had considerable impact on the health economy. Switching to a biosimilar has proven to be an effective, safe and pharmacoeconomically advantageous strategy for health systems.

Clinical evidence for interchangeability of biosimilars in the US

Biosimilars/Research | Posted 29/01/2021

In the United States, the Food and Drug Administration (FDA) approval of a biosimilar is based on the ‘totality of the evidence’ from comparative analytical and functional assessments and comparative clinical (pharmacology, immunogenicity, safety and efficacy) assessments that support a conclusion of biosimilarity [1]. An approved biosimilar can also be designated as ‘interchangeable’ if it can be concluded that the biosimilar is expected to produce the ‘same clinical result as the reference product in any given patient’ and there is no increased risk in terms of safety or diminished efficacy associated with switching or alternating between the biosimilar and reference product (RP) [2]. With such designation, an interchangeable biosimilar could be substituted for its RP at the pharmacy level where state law allows [2].

How organizations worldwide are producing HTA reports for biosimilars

Biosimilars/Research | Posted 22/01/2021

The vital contribution of Health Technology Assessment (HTA) is well recognized and consolidated in scientific and technological practice; however, there is still no generally accepted position on its utilization in relation to biosimilars.

Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany

Biosimilars/Research | Posted 15/01/2021

In Europe, the individual Member States are responsible for designing policies that regulate the market entry and use of pharmaceuticals. This decentralized approach has been found to contribute to variations in biosimilar uptake across countries, and even within countries, as was investigated for tumour necrosis factor-alfa (TNF-α) inhibitor biosimilars in Sweden [1, 2]. In Germany, biosimilar market shares are also known to vary at the regional level. This was studied by Blankart et al. for erythropoiesis-stimulating substances, filgrastim and somatropin, and variations in biosimilar market shares were partly attributed to the presence of explicit regional cost-control measures, such as quota regulations [3]. Differences in the uptake of biosimilars have also been described in Germany for the class of TNF-α inhibitors, although reasons behind this variable uptake have not been examined in detail [4].

Positive phase III results for sintilimab plus copy biological Byvasda

Biosimilars/Research | Posted 15/01/2021

Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced on 23 November 2020 positive results for its copy bevacizumab biological Byvasda (IBI-305) in combination with sintilimab.

More national guidance needed on biosimilars in Europe

Biosimilars/Research | Posted 08/01/2021

A poster presented at the Virtual ISPOR (International Society for Pharmacoeconomics and Outcomes Research) 2020 conference outlines the importance of regulatory guidance on biosimilar medicines in Europe.

Phase I study comparing SB8 with reference bevacizumab

Biosimilars/Research | Posted 08/01/2021

SB8, developed by Samsung Bioepis, was approved as a biosimilar of the reference product Avastin (bevacizumab) by the European Commission in August 2020 with the brand name of Aybintio [1]. The objective of this phase I study was to compare the pharmacokinetics, safety, tolerability and immunogenicity between SB8 and the European Union (EU) and United States (US) reference products (bevacizumab-EU and bevacizumab-US).

Scientific, legal and regulatory challenges facing biosimilars development

Biosimilars/Research | Posted 11/12/2020

Abbreviated approval pathways for biosimilars – biological products that are highly similar to an originator biological with regard to quality, safety and efficacy [1, 2] – were created to foster competition and lower prices for biological treatments. However, these desired effects have not materialized as quickly as expected in either the US or the European Union.

Safety monitoring for immune-modulating biologicals

Biosimilars/Research | Posted 11/12/2020

A study of adverse events among patients with autoimmune disease identifies numerous cases of serious infection. The study also demonstrates the ability of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) to function as a surveillance platform [1].

Real-world data on biosimilars in inflammatory arthritis treatment

Biosimilars/Research | Posted 04/12/2020

The use of biologicals in patients with rheumatic diseases has achieved the therapeutic target, i.e. remission or low disease activity. The share of biologicals has been growing with the approval of biosimilars, which have been recognized for their equivalent efficacy, safety, pharmacokinetics and immunogenicity to the originator, as well as their reduced economic burden.

Study reveals wide variation in US state drug product substitution laws

Biosimilars/Research | Posted 04/12/2020

A new study, published in JAMA Internal Medicine [1], has revealed substantial variation in the drug product substitution rules for pharmacists across states in the US.

Asia Pacific countries: future demand for biosimilars

Biosimilars/Research | Posted 27/11/2020

The prevalence of chronic diseases like diabetes, cancer and rheumatoid arthritis have been increasing globally, resulting in an ever-growing need for biologicals that are affordable and accessible in the Asia Pacific countries (APAC). Biosimilars are ‘similar’ versions of approved and authorized biological medicines that are already on the market. They typically sell at discounts ranging from 20% to 35% when compared to the reference product [1]. It is expected that introduction of biosimilars into the global markets will erode the total sales of biologicals by as much as 54% through 2022 [2]. Various regulatory bodies such as the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and the World Health Organization (WHO) actively regulate development and commercialization of biosimilars.

Biopharmaceuticals and biosimilars: regulatory challenges for global harmonization of GMP standards

Biosimilars/Research | Posted 27/11/2020

A recent GaBI Journal [1] article by Sia et al. has explored biopharmaceutical good manufacturing practice (GMP) standards around the globe. The authors uncovered the challenges faced in attempting to achieve global harmonization of biopharmaceutical GMP standards.

Discontinuation following biosimilar switching in IBD patients

Biosimilars/Research | Posted 20/11/2020

Medical management of inflammatory bowel diseases (IBD) has significantly improved since the introduction of biological therapies over the past 20 years. The adoption of biologicals in IBD care has led to an exponential increase in treatment-related costs, resulting in a huge economic impact. As the patents of older biologicals expire, the interest in marketing comparable versions of the reference products increases, enabling opportunities for the development of similar biological products. Biosimilars have the potential to expand access to biological therapies due to price competition and cost savings [1].

Global harmonization of GMP standards for biologicals

Biosimilars/Research | Posted 20/11/2020

Biopharmaceuticals are complex as their active pharmaceutical ingredient (API) is manufactured using living systems. In turn, this leads to complex manufacturing processes. A recent GaBI Journal [1] article by Sia et al. has investigated the good manufacturing practice (GMP) standards of various global regulatory authorities (RAs) and international organisations (IOs). It has revealed that we are well on the way to global harmonization of GMP standards that will help bring these products to more people across the globe.

A blueprint for biosimilar assessment without efficacy trials

Biosimilars/Research | Posted 13/11/2020

Comparative efficacy trials have played an important role in biosimilarity assessments. However, with recent technological advances, their role is now being questioned. Research published in Drug Discovery Today [1] outlines the reasons why biosimilar assessments can now be carried out without these trials [2, 3]. It also lays out the requirements for prospective applications without efficacy trials.

Copy biological approvals in China, compared to the US and EU

Biosimilars/Research | Posted 13/11/2020

A review of copy biological approvals in China finds that 75% of approved monoclonal antibodies, fusion proteins and granulocyte colony-stimulating factor (G-CSF) copy biologicals have been successfully commercialized in the country [1].

Rationale for biosimilar assessment without efficacy trials

Biosimilars/Research | Posted 06/11/2020

An article published in Drug Discovery Today explores the necessity of the clinical efficacy trial in biosimilarity assessments [1].

Shared decision-making and the transition to biosimilars

Biosimilars/Research | Posted 06/11/2020

Increasing healthcare cost are forcing health authorities to look for low-cost innovations to help bend the cost curve. Biosimilars, a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biological, are such an innovation [1]. Because biosimilars are often offered at lower prices, their use has been promoted all across the world. The initiating of biosimilars in bio-naïve patients is already commonplace in many countries. However, the transitioning from originator biological to its biosimilar for non-medical reasons is still debated. Different strategies about how and when to transition are formulated and applied.

Role of efficacy trials in biosimilar assessments questioned

Biosimilars/Research | Posted 30/10/2020

In recent years, the role of the comparative efficacy trial in biosimilar assessments has been brought into question. This is explored in a recent article published by Bielsky and colleagues [1].

Perceptions of biosimilars and switching in Arab rheumatologists

Biosimilars/Research | Posted 30/10/2020

The introduction of biosimilars into the rheumatology field could lead to dramatic cost savings as has been observed in certain European countries. Their implementation and acquisition, however, is not the same across the world. Many rheumatologists have developed a negative perception toward biosimilars and the process of non-medical switching. As important stakeholders, their views and concerns need to be addressed to ensure an effective introduction of these therapeutic agents. Mohammed Omair and colleagues evaluated how Arab rheumatologists perceive biosimilars in view of understanding the manufacturing and approval process during the Arab League Against Rheumatism Conference (ArLAR) [1].

Biosimilar assessments: do we need efficacy trials?

Biosimilars/Research | Posted 23/10/2020

Regulatory guidelines for biosimilar approval have existed in Europe since 2004. These are based on the totality of evidence from comparative studies with reference products and have always required comparative efficacy studies. However, a recent article by Bielsky et al., published in Drug Discovery Today [1], explores the increasingly questioned role of the clinical efficacy trial in biosimilar approval.

Biopharmaceuticals and biosimilars: manufacturing challenges

Biosimilars/Research | Posted 23/10/2020

Biopharmaceuticals include a complex active pharmaceutical ingredient (API). This is manufactured using living systems such as microbial and mammalian cells which makes manufacture a complicated process. A recent paper by Sia et al. published in GaBI Journal [1] has explored current biopharmaceutical processes and the challenges posed by manufacturer.

Biopharmaceuticals and biosimilars: manufacturing processes

Biosimilars/Research | Posted 16/10/2020

The active pharmaceutical ingredient (API) in biopharmaceuticals is manufactured using living systems such as microbial and mammalian cells. Due to this, their manufacture is complex. A recent review by Sia et al. published in GaBI Journal [1] has carried out an in-depth exploration of current biopharmaceutical manufacturing processes.

Pharmacists are key to quality use of medicines for biosimilars

Biosimilars/Research | Posted 16/10/2020

A commissioned review in The Pharmaceutical Journal [1] on interchangeability of biosimilars highlights the pivotal role pharmacists play in the adoption and appropriate use of biosimilars.

Clinical review of biosimilars approved in oncology

Biosimilars/Research | Posted 09/10/2020

As cancer therapeutics constitutes a large proportion of the biologicals market, and patents have begun to expire, biosimilars have an important role in optimizing patient access and reducing costs in the oncology therapeutic area. Authors Ngo and Chen from the City of Hope National Medical Center, Los Angeles, USA, give an overview of the US Food and Drug Administration (FDA)-approved biosimilars in oncology and their impact on the healthcare system in the Annals of Pharmacotherapy [1]. A summary of the main findings from that article follows.

Biopharmaceuticals and biosimilars: challenges in manufacture, regulation and international harmonization of GMP

Biosimilars/Research | Posted 09/10/2020

Biopharmaceuticals are large molecules that are far more complex than traditional, chemical pharmaceuticals. With patent expiry for many originators, biosimilar versions are expected to flood the market in the years to come. However, the active pharmaceutical ingredients (APIs) of all such products are manufactured using living systems which means that their manufacture and characterization is also complex.

Why biosimilar applications fail during regulatory evaluation?

Biosimilars/Research | Posted 02/10/2020

The patent expirations of many blockbuster biologicals have paved the way for development of biosimilars and this has the potential to enhance access to otherwise high-cost biological therapies. Given the complexity of biologicals, the regulatory guidelines for biosimilar approval are meticulous and different from generics. Hence biosimilar developers often face issues during the application evaluation by regulatory authorities. With large number of biosimilars in development stage, it is pertinent for a manufacturer to have a deep understanding of the regulatory approval process. Rathore and colleagues from the Indian Institute of Technology offer insights into the objections raised by the regulatory authorities during evaluation of biosimilar applications for marketing authorization with special emphasis on applications reviewed by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Spectroscopy remains dominant when investigating biosimilar structures

Biosimilars/Research | Posted 02/10/2020

Biopharmacological studies, including biosimilar studies, require investigation of the higher order structure of proteins. A recent review published in GaBI Journal (GABIJ) [1] has found that, although many analytical methods to determine the higher order structures exist, spectroscopic methods remain the most used.

Phase III trial updates of Samsung Bioepis’ bevacizumab and aflibercept biosimilars

Biosimilars/Research | Posted 25/09/2020

Samsung Bioepis has reported positive results from a phase III trial of its bevacizumab biosimilar, Aybinto. The company is also initiating a phase III trial for its aflibercept biosimilar, SB15.

FDA to investigate PD biomarkers to show biosimilarity

Biosimilars/Research | Posted 25/09/2020

The US Food and Drug Administration (US FDA) is conducting research on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. A study published in Clinical Pharmacology and Therapeutics, has outlined how the agency hopes to inform their thinking on critical aspects of how these biomarkers can be used to reduce the need for comparative clinical studies [1]. In turn, this can reduce the time and cost of bringing a biosimilar product to market, giving faster access to affordable, safe, and effective treatments.

Biosimilars allow fast access to biological drug therapy in Bavaria, Germany

Biosimilars/Research | Posted 18/09/2020

A new study has shown that patients suffering from rheumatism in Bavaria, Germany, are now likely to be prescribed a biological medicine much faster than five years ago. Results of the study were shared at the AG Pro Biosimilars digital symposium on 14 September 2020.

What oncologists do not understand about biosimilars

Biosimilars/Research | Posted 18/09/2020

The availability of biosimilars may improve access to health care by increasing the number of therapeutic options available at potentially lower costs. However, based on the results of multiple surveys of many healthcare providers (HCPs) conducted in recent years, clinicians appear wary of prescribing biosimilars.

Budget savings from biosimilar infliximab in the UK, France, Japan and Korea

Biosimilars/Research | Posted 11/09/2020

Biological medicines are attracting attention from policymakers and health insurers across countries due to their increased financial burden. The potential for biosimilars’ cost savings can be influenced by various factors, including supply-side (pricing policies) and demand-side (usage-enhancing) policies.

Celltrion’s biosimilars effective against gastric cancer and B-cell lymphoma

Biosimilars/Research | Posted 11/09/2020

Recent clinical trial results confirm that Celltrion’s biosimilars Herzuma (trastuzumab) and Truxima (rituximab) are effective in the treatment of gastric cancer and B-cell lymphoma, respectively.

Monoclonal antibody biosimilars and cancer in the EU

Biosimilars/Research | Posted 04/09/2020

Spanish researchers investigated the current status of biosimilar monoclonal antibodies (mAbs) in the European Union (EU) by reviewing the regulatory pathway, the rationale for extrapolation and switching and the current status and future perspectives of the biosimilars approved in the EU [1].

Biosimilars in oncology in Europe

Biosimilars/Research | Posted 01/12/2017

In the European Union (EU), a legal framework for approving biosimilars was established back in 2003. This framework allows for biosimilars to be approved using an abbreviated pathway centrally via the European Medicines Agency (EMA) [1].

The biosimilars market in Latin America: a summary

Biosimilars/Research | Posted 28/08/2020

A review of the biosimilars market in Latin America [1] finds that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in other countries is more limited. The review recommends investment in biotechnology hubs and further development of regulation on biological drugs.

Adalimumab copy biological shown to be safe and effective

Biosimilars/Research | Posted 11/10/2019

Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.

Sustainable biosimilar policies in Europe

Biosimilars/Research | Posted 31/07/2020

A review of approaches to biosimilar policy in Europe [1] highlights key principles for a sustainable biosimilar market, including supporting innovation and allowing for multiple suppliers.

Biosimilar infliximab reduces medication costs by two thirds in Finland

Biosimilars/Research | Posted 31/07/2020

A study of 54 people with inflammatory bowel disease (IBD) in Finland showed that switching to biosimilar infliximab has no significant impact on health-related quality of life or disease activity, while reducing costs by two thirds [1].

Trastuzumab biosimilar Kanjinti is stable over extended storage periods

Biosimilars/Research | Posted 24/07/2020

An investigation of the quality and in-use stability of diluted trastuzumab biosimilar Kanjinti (also known as ABP 980) versus the reference trastuzumab demonstrated no clinically meaningful differences in stability and activity over extended storage periods, according to Crampton et al. [1].

Quotas improve biosimilar use in Germany

Biosimilars/Research | Posted 17/07/2020

An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].

Denmark achieves 83% reduction in adalimumab costs through switching

Biosimilars/Research | Posted 10/07/2020

Spending on adalimumab in Denmark decreased by almost 83% between September and December 2018, thanks to a mandatory switching policy.

Biosimilars in Belgium: increasing competition

Biosimilars/Research | Posted 03/07/2020

Competition following the entry of biosimilars is still limited in Belgium, which is mirrored in low biosimilar market shares. Although (short-term) cost savings are realized by the implementation of mandatory price reductions on originator medicines (and obtaining high biosimilar market shares should thus not be a goal in itself), biosimilars can play a key role in ensuring the long-term sustainability of the Belgian off-patent biologicals market.

Positive phase I results for Innovent’s ipilimumab copy biological

Biosimilars/Research | Posted 03/07/2020

China-based Innovent Biologics (Innovent) announced on 3 June 2020 positive phase I results for its candidate ipilimumab copy biological, IBI310.

Successfully transitioning patients with IBD to biosimilars

Biosimilars/Research | Posted 26/06/2020

Pharmacists and physicians from the Boston Medical Center describe the successful transition of patients with inflammatory bowel disease (IBD) using the originator infliximab biological, Remicade, to the infliximab biosimilar, Inflectra (infliximab-dyyb) [1].

EULAR recommendations for DMARDs in rheumatoid arthritis

Biosimilars/Research | Posted 26/06/2020

The European League Against Rheumatism (EULAR) has updated its recommendations on the management of rheumatoid arthritis (RA) using synthetic and biological disease-modifying antirheumatic drugs (DMARDs) [1].

Positive phase Ib results for TYVYT + bevacizumab copy biological IBI305

Biosimilars/Research | Posted 19/06/2020

China-based Innovent Biologics (Innovent) announced on 1 June 2020 positive results for a phase I trial of its candidate bevacizumab copy biological, IBI305, in combination with TYVYT (sintilimab injection) in the treatment of advanced hepatocellular carcinoma, which is the most common form of liver cancer.

Clinical equivalence in oncology biosimilar trials

Biosimilars/Research | Posted 19/06/2020

Researchers from the US propose using restricted mean survival time (RMST) rather than the overall response rate (ORR) and progression-free survival (PFS) or overall survival (OS) in clinical trials evaluating the equivalence of biosimilars [1].

Use of biosimilar infliximab gives savings for patients

Biosimilars/Research | Posted 12/06/2020

Canadian researchers carried out a cost-utility analysis of switching from reference to biosimilar infliximab compared to maintaining reference infliximab in adult patients with Crohn’s disease (CD). From this analysis they found that using biosimilar infliximab resulted in cost savings for patients [1].

Patients’ perceptions of switching to biosimilars

Biosimilars/Research | Posted 05/06/2020

A patient’s characteristics make them more likely to have negative perceptions about switching to biosimilars, according to a study by researchers from New Zealand [1].

Clover starts phase III trial for etanercept copy biological in China

Biosimilars/Research | Posted 27/03/2020

At the end of December 2019, Clover Biopharmaceuticals (Clover), a Chinese company focused on biological therapies, announced the start of a phase III trial of their etanercept copy biological (SCB-808), a proposed copy biological to originator biological Enbrel (etanercept).

Positive phase I results for Qilu’s bevacizumab copy biological

Biosimilars/Research | Posted 20/03/2020

Positive results were reported from a phase I trial of a bevacizumab copy biological, QL1101, which the authors say is ‘the first study to compare the pharmacokinetics of QL1101, a proposed bevacizumab [copy biological], with Avastin’ [1].

Positive results for Bio-Thera’s bevacizumab copy biological

Biosimilars/Research | Posted 28/02/2020

China-based Bio-Thera Pharmaceuticals (Bio-Thera) announced positive results from a phase III trial of its bevacizumab copy biological.

How to make biological drugs more affordable

Biosimilars/Research | Posted 08/05/2020

Biological drugs remain unaffordable for many in the US due to strategies used by pharmaceutical companies and negative messaging about biosimilars, explains a recent commentary by Dr Joel Lexchin, School of Health Policy and Management at York University, Canada [1].

Use of anti-TNF biosimilars in the US

Biosimilars/Research | Posted 03/04/2020

Uptake of biosimilars in the US is slow to say the least. In fact, biosimilars currently make up only 2.3% of the US biologicals marketplace [1]. Researchers from the US therefore investigated whether anti-tumour necrosis factor (anti-TNF) biosimilars are realizing their promise to increase competition and improve accessibility in the US [2].

Relative bioavailability of FKB327 when administered using different methods

Biosimilars/Research | Posted 14/02/2020

FKB327 is a biosimilar of Humira (adalimumab), a recombinant, human immunoglobulin G1 monoclonal antibody specific for human tumour necrosis factor alpha (TNF-α). The European Medicines Agency approved FKB327, as Hulio, in 2018 [1].

Biosimilars in the age of patient-centricity

Biosimilars/Research | Posted 06/03/2020

In 2020, nearly all pharmaceutical companies claim to be ‘patient-centric’. In fact, some companies have even initiated processes of designing new treatments ‘around the patient’ and convened ‘Patient Advisory Boards’ to ensure patients provide their input into clinical trial design. In addition, though to a lesser extent, some have also developed educational programmes to ensure clinicians and patients truly understand the use and function of biosimilars. Regulators have also participated in the effort to ensure that patients consent to be prescribed biosimilar treatments and are well informed of their relative risks and benefits. President of the French Association of Pharmaceutical Medicine, Dr Francois-Xavier Frapaise, discusses how these latest ‘patient-centric’ efforts affect patients [1].