Biosimilars/Research

Etanercept biosimilar SB4 less immunogenic than Enbrel

Biosimilars/Research | Posted 06/04/2018

A research letter published in the British Journal of Dermatology suggests that the biosimilar etanercept SB4 is less immunogenic than the originator product, Amgen/Pfizer’s Enbrel (etanercept) [1].

Government policies to maximize social benefit of biosimilars in countries with restricted access to biologicals

Biosimilars/Research | Posted 30/03/2018

The potential value of biosimilars is dependent on patient access to originator biologicals in a given country. If the originator biological is reimbursed without any volume and access restrictions, the main objective of using biosimilars is to generate savings in health expenditures without compromising health outcomes. This disinvestment scenario is mainly applicable for higher income countries. If the original biological product is reimbursed with volume and access restrictions, the main objective of biosimilars is to treat more patients from the same healthcare budget, and hence generate more health gain. This special investment scenario is applicable for lower income European Union (EU) Member States and other middle-income countries. If the originator biological is not reimbursed at all, more affordable biosimilars may create an opportunity for public reimbursement, however, incremental budget is needed to generate more health gain. This investment scenario is applicable for low-income countries [1].

Yoshindo and Lupin’s etanercept biosimilar completes trials

Biosimilars/Research | Posted 23/03/2018

YL Biologics announced on 7 February 2018 that the global phase III trials of its etanercept biosimilar have been a success. YL Biologics is a joint venture of India’s Lupin Ltd and Japanese firm Yoshindo that was first announced in 2014 [1]. The etanercept biosimilar has met a successful outcome for rheumatoid arthritis treatment and hopes to compete for a share of the originator Enbrel’s global market of US$11 billion.

PK and PD comparison between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

Biosimilars/Research | Posted 23/03/2018

A requirement for registration of a biosimilar is to demonstrate pharmacokinetic (PK) similarity with the reference product. A population PK model approach is an excellent method for assessing PK similarity, in contrast to the classical one, because it allows comparison of PK properties through the inclusion of sparse data that improves the power to detect any potential differences between the biosimilar and the reference product. Furthermore, the population approach allows quantification of the inter-product and inter-subject variability of PK parameters and identification of covariate factors (demographic, pathophysiological, environmental or concomitant drugs) that influence drug availability [1].

Follow-on biologicals and extrapolation in Brazil

Biosimilars/Research | Posted 16/03/2018

Researchers from Brazil discuss the country’s approach to follow-on biologicals and extrapolation of indications in the country [1].

Biosimilar policies around the globe

Biosimilars/Research | Posted 16/03/2018

With the authorization of an increasing number of biosimilars, and the prospect of multiple biosimilar switching, biosimilar naming and the importance of this for pharmacovigilance are coming into sharper focus. Authors from around the world considered various biosimilar issues/policies in different countries and regions [1].

Use and cost of biologicals for cancer treatment in Southern Italy

Biosimilars/Research | Posted 09/03/2018

Oncological-targeted therapies, both biological and non-biological, represent a significant clinical and economic burden in routine care and have a major impact on the sustainability of National Health Services. With this in mind, a study by Lucchesi et al. investigated the use and costs of these targeted therapies for cancer treatment in the general population of Southern Italy during the period 2010−2014 [1].

Structure-function relationship between disulfide bonds and TNF-α neutralization in etanercept

Biosimilars/Research | Posted 09/02/2018

Research carried out by Sandoz describes how a novel incorrect disulfide bridge structure present at low levels in commercial etanercept inhibits etanercept potency by reducing its ability to neutralize soluble tumour necrosis factor alpha (TNF-α) [1].

Pharmacy-mediated substitution: the global policy landscape

Biosimilars/Research | Posted 02/03/2018

There is a complex global regulatory landscape when it comes to biosimilars. In particular, there is much debate over substitution practices. Substitution describes the practice where a pharmacist decides to change a product, dispensing an equivalent (generic small molecule) or highly similar product (biosimilar) without the prescribing physician’s prior consent. This is distinct from switching, whereby a physician changes a patient’s treatment, between reference product and a biosimilar, or between biosimilars. Between March and May 2017, Pfizer conducted an internal global survey of 82 countries in which it examined biosimilar pharmacy-mediated substitution. Here, the company hoped to understand and benchmark the global policy landscape [1].

Kissei/JCR’s darbepoetin alfa biosimilar shows equivalent safety and efficacy

Biosimilars/Research | Posted 02/03/2018

Japan-based collaborators Kissei Pharmaceutical (Kissei) and JCR Pharmaceuticals (JCR) announced on 17 January 2018 positive results for the phase III study of their candidate darbepoetin alfa biosimilar, JR‑131.

Strategies of players on the global biopharmaceutical market

Biosimilars/Research | Posted 08/09/2017

With many expensive and high-selling biologicals losing patent protection and other exclusivity rights, biosimilars of these molecules may now enter the market, resulting in a shift of market shares, revision of strategies of companies and attraction of new players to the biopharmaceutical market.

Barriers to the market access of biosimilar monoclonal antibodies

Biosimilars/Research | Posted 25/08/2017

In September 2013, the first biosimilar monoclonal antibody (mAb) was approved by the European Medicines Agency (EMA), i.e. biosimilar infliximab (Inflectra/Remsima). These products entered the European market in 2015, after expiry of patent and other exclusivity rights of the innovator medicine Remicade. With the ever-increasing cost of health care and the economic pressure to reduce or sustain healthcare expenses, biosimilars could be instrumental in reducing cost for medication and increasing patient access to treatment. Although exclusivity rights of multiple mAbs are expired (rituximab in 2013, trastuzumab in 2014), only recently biosimilar mAbs other than infliximab are receiving marketing authorization (rituximab, adalimumab). Furthermore, earlier biosimilars have seen slow uptake in European markets. This may imply that several barriers hinder market access of biosimilar mAbs.

Generics versus biosimilars: pricing and usage-enhancing policies

Biosimilars/Research | Posted 23/02/2018

In Europe, pricing and demand-side measures for generic medicines are widely implemented and have undergone evaluations [1-4]. However, when it comes to biosimilars, the policies implemented by European countries are less well known and explored.

Etanercept switching study investigates non-mandatory transitioning

Biosimilars/Research | Posted 23/02/2018

A study carried out by researchers from The Netherlands investigated whether non-mandatory transitioning from originator to biosimilar etanercept improves retention rates [1].

EBE reveals Europe’s biosimilar pricing and reimbursement policies landscape

Biosimilars/Research | Posted 15/02/2018

The first biosimilar was approved in the European Union (EU) in 2006. Since then, biosimilar policies have been developed with a focus on increasing biosimilar uptake. However, the extent to which EU Member State polices differentiate between biosimilars and generic medicines has been brought into question. The European Biopharmaceutical Enterprises (EBE) has conducted a second survey on pricing and reimbursement policies for off-patent biologicals to map the biosimilar policy landscape in Europe [1].

Quality and clinical performance of biopharmaceuticals

Biosimilars/Research | Posted 15/02/2018

A review carried out by researchers from Sandoz describes the inherent nature of biopharmaceutical heterogeneity and discusses modern quality systems and regulatory frameworks used to maintain biopharmaceutical quality and clinical performance [1].

Zarxio reveals all: the US biosimilars market

Biosimilars/Research | Posted 09/02/2018

Launched in 2015, Zarxio (filgrastim-sndz) was the first biosimilar to gain US Food and Drug Administration (FDA) approval [1]. It competes with Neupogen (its reference product), Granix and Neulasta, for a share of the neutropenia market. This approval came almost a decade after the 2006 launch of the first biosimilar in Europe. Following this, a new study has examined Zarxio’s first years’ performance in the US short-acting (SA) filgrastim market to identify key sales and marketing trends and their drivers [2].

The biosimilar landscape in Italy revealed

Biosimilars/Research | Posted 02/02/2018

In Italy, health services are run at the regional level. To date, there has been no systematic monitoring of the uptake of biosimilars at a national or regional level. As such, the biosimilar landscape in Italy has not been well understood. However, a recent paper now provides an overview of the available real-world data relating to the patterns of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy [1].

Danish etanercept switching study investigates withdrawal rates

Biosimilars/Research | Posted 02/02/2018

A study carried out by researchers from Denmark has investigated switching from originator to biosimilar etanercept 1-year post switch [1].

Switching to biosimilars in rheumatology

Biosimilars/Research | Posted 26/01/2018

Researchers from Argentina, Brazil, Germany, the UK and the US investigated switching from originator biologicals to biosimilars [1].

Additional clinical data for Cinfa’s pegfilgrastim biosimilar

Biosimilars/Research | Posted 19/01/2018

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 2 November 2017 additional clinical data for its candidate pegfilgrastim biosimilar (B12019).

Switching failures with biosimilar etanercept

Biosimilars/Research | Posted 12/01/2018

A study carried out by researchers from Denmark has found that switching from originator to biosimilar etanercept does not work for all patients [1].

Reimbursement for oncology biosimilars in the US

Biosimilars/Research | Posted 05/01/2018

How reimbursement issues for biosimilars might affect US oncologists was a subject discussed by Dr Rena Conti, Associate Professor of Health Policy and Economics in the Department of Paediatrics at the University of Chicago, USA [1].

Impact of follow-on biological products in the Brazilian health system

Biosimilars/Research | Posted 05/01/2018

Cancer is an epidemic disease in the 21st century. However, despite consistent increases on its incidence worldwide, mortality rates have fallen, especially in developed countries [1, 2]. The victories mankind has achieved in the war against cancer result from advances in different fields, such as early diagnosis and better surgical, radiotherapeutic and systemic treatments.

Hospital specialists and pharmacists surveyed about biosimilars

Biosimilars/Research | Posted 08/12/2017

Biological medicines are essential for many acute and chronic conditions, but their consumption differs widely among European countries [1, 2]. In contrast with the procedures for their approval[3], position papers from scientific societies suggest that biosimilars need to be tested in well-designed, randomized, controlled clinical trials, especially for extrapolation of indications [4, 5]. Nevertheless, switches with originators are becoming common and no serious adverse effects have been reported to date [6-8].

Positive phase III switching results for Celltrion’s infliximab biosimilar

Biosimilars/Research | Posted 08/12/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) infliximab biosimilar (CT-P13) is shown to be comparable in efficacy and safety to Johnson & Johnson/Merck’s Remicade in switched inflammatory bowel disease patients, according to the South Korean biotechnology company.

Switching from reference infliximab to CT P13 in IBD patients

Biosimilars/Research | Posted 01/12/2017

Argüelles-Arias and colleagues from the Hospital Universitario Virgen Macarena and the University of Seville in Spain carried out an observational study assessing the efficacy and safety of switching from Remicade to CT P13 in patients with inflammatory bowel disease (IBD) for up to 12 months [1].

Switching to biosimilar infliximab in IBD patients

Biosimilars/Research | Posted 24/11/2017

Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options, such as CT‑P13 (Remsima/Inflectra), promises to improve the availability of biological therapy.

Biosimilars in oncology in the US

Biosimilars/Research | Posted 24/11/2017

As part of the Affordable Care Act of 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) allows for an abbreviated license pathway for the approval of biosimilars in the US. In light of continuing increases in healthcare costs, particularly for cancer drugs, use of biosimilars is increasingly being considered as a strategy for containing the cost of cancer care, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [1, 2].

Loss of efficacy after switching to biosimilar infliximab in Behcet’s patients

Biosimilars/Research | Posted 17/11/2017

Authors from the Division of Rheumatology at the Hospital of Prato, Italy report on three patients with Behçet’s disease that experienced disease relapses after switching from the originator infliximab, Remicade, to biosimilar infliximab [1].

Opportunities and challenges for biosimilars in oncology

Biosimilars/Research | Posted 17/11/2017

The rapid increase in healthcare costs, particularly for cancer drugs, has had a major impact on providers, practices, payers and patients, according to Dr Gary Lyman of the Fred Hutchinson Cancer Research Center and University of Washington, Seattle, WA, USA [1, 2].

Phase III switching data support long-term efficacy and safety of rituximab biosimilar Truxima

Biosimilars/Research | Posted 10/11/2017

Results of a phase III extension study have shown that Celltrion Healthcare’s (Celltrion) rituximab biosimilar (Truxima, CT-P10) is comparable to Roche’s MabThera/Rituxan, according to the South Korean biotechnology company.

Physicochemical and biological characterization study of copy biological tocilizumab

Biosimilars/Research | Posted 10/11/2017

Researchers in China have developed a copy biological of F. Hoffmann-La Roche’s (Roche) arthritis treatment Actemra (tocilizumab). A recent study compares it to the originator, finding it to be highly similar in terms of its physical, chemical and biological characteristics [1].

Australian prescribers’ views on biologicals naming and substitution

Biosimilars/Research | Posted 03/11/2017

In a survey of 160 prescribers of biologicals in Australia, over three quarters agreed that the country’s Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific names for all biosimilars and reference products. The results of the survey were published just as TGA launched a public consultation on proposals for potential biological naming systems. A clear majority (98%) of prescribers who took part in the survey, run by the Alliance for Safe Biologic Medicines (ASBM), said they currently used either brand name or non-proprietary scientific names for recording and prescribing biosimilars and reference products [1]. Most (61%) wanted TGA to play a major role in naming biosimilars.

Biosimilar insulins – reducing the cost of diabetes

Biosimilars/Research | Posted 03/11/2017

Will biosimilar insulins be cheaper is a question raised by authors Lutz Heinemann and Alan Carter and one that they say is a clear yes [1].

European perspective on biosimilars

Biosimilars/Research | Posted 27/10/2017

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The first biosimilar Omnitrope (somatropin) was approved in 2006 [1].

Anti-drug antibody assays for biosimilars and originator biologicals

Biosimilars/Research | Posted 27/10/2017

Biosimilar drug development has brought new challenges to bioanalytical ligand-binding assays used to determine drug concentration, anti-drug antibodies and neutralizing antibodies.

Challenges and opportunities in producing biosimilars

Biosimilars/Research | Posted 20/10/2017

In a viewpoint article published in ACS Medicinal Chemistry Letters [1], Dahodwala and Sharfstein discuss the challenges and opportunities faced by biopharmaceutical manufacturers in producing biosimilars, equivalent versions of therapeutic proteins, and the role of regulatory agencies, particularly the US Food and Drug Administration (FDA), in approving these compounds.

Bevacizumab improves survival in NSCLC patients

Biosimilars/Research | Posted 20/10/2017

In what could be good news for recently approved bevacizumab biosimilar Mvasi, a study has shown that bevacizumab-containing regimens improve survival in advanced non-squamous non–small cell lung cancer (NSCLC) patients.

Adalimumab biosimilar ABP 501 shows similar efficacy, safety and immunogenicity

Biosimilars/Research | Posted 13/10/2017

Biosimilars are defined by the US Food and Drug Administration (FDA) as a biological product that is ‘highly similar to’ an approved biological product (the ‘reference’ or ‘originator’ or ‘bio-originator’ product) and that has ‘no clinically meaningful differences’ in safety or effectiveness compared to the reference product.

Barriers to access to biosimilars

Biosimilars/Research | Posted 13/10/2017

Barriers to the use of biosimilars include healthcare professional and patient opinions. But national and local guidelines, levels of funding and differing approaches to healthcare management can also influence access to biosimilars in different Member States of the European Union (EU), according to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway [1].

Integrating biosimilars into clinical practice

Biosimilars/Research | Posted 06/10/2017

According to authors from the National Advisory Unit on Rehabilitation in Rheumatology and the Rheumatology Department of Diakonhjemmet Hospital, Oslo, Norway, key questions when it comes to biosimilars include interchangeability, switching and automatic substitution [1].

Biosimilars for rheumatic diseases

Biosimilars/Research | Posted 29/09/2017

Biologicals have become central to the long-term management of many chronic diseases, including inflammatory rheumatic diseases. Biosimilars may help to fill an unmet need by improving patient access to effective biological treatments for chronic diseases. In light of these facts, authors from Norway reviewed biosimilars for rheumatic diseases [1].

Equivalence of rituximab biosimilar in rheumatoid arthritis

Biosimilars/Research | Posted 29/09/2017

A network meta-analysis was used by researchers from Italy to ‘reinforce the clinical data available’ for the equivalence of the rituximab biosimilar CT‑P10 [1].

Positive phase III results for Pfizer’s trastuzumab biosimilar

Biosimilars/Research | Posted 22/09/2017

Pharma giant Pfizer announced on 10 September 2017 positive results from the pivotal phase III study of its candidate trastuzumab biosimilar. Pfizer says that ‘data from the REFLECTIONS B327-02 study demonstrates equivalence in objective response rate (ORR) for patients with HER2-positive metastatic breast cancer’.

Comparable efficacy and safety observed in patients switched to biosimilar CT-P10

Biosimilars/Research | Posted 22/09/2017

Rituximab is a monoclonal antibody that targets the CD20 protein that is primarily found on B lymphocytes. Through depletion of CD20-positive B cells in the peripheral blood and bone marrow, rituximab is effective for treating some haematological malignancies and immune-mediated diseases such as rheumatoid arthritis (RA). CT-P10 (Truxima) is a biosimilar of the rituximab reference product. It is the first biosimilar to receive market authorization from the European Medicines Agency and is approved in Europe for all indications for which RTX is licensed [1]. A phase I randomized controlled trial (RCT) in patients with RA demonstrated pharmacokinetic equivalence of CT-P10 and reference rituximab over 24 weeks of treatment [2], and comparable efficacy and safety of these two drugs has recently been demonstrated over an extended treatment duration from the same trial [3]. With biosimilars typically being less expensive than originator biologicals [4], it is of interest to know whether patients treated with an originator biological can be switched to a biosimilar to save healthcare costs and increase access without affecting treatment efficacy or safety. An open-label extension (OLE) study that enrolled patients who had completed the aforementioned phase I RCT has been published [5]. The study has demonstrated comparable efficacy and safety profiles in patients who switched from the reference rituximab to CT-P10 and those maintained on CT-P10 throughout treatment [5].

Positive phase III results for Amgen’s trastuzumab biosimilar

Biosimilars/Research | Posted 15/09/2017

Biotech giant Amgen and partner Allergan announced on 9 September 2017 positive data from a phase III study of their trastuzumab biosimilar (ABP 980) compared to Herceptin (trastuzumab).

Positive phase I results for rituximab biosimilar CT-P10 in patients with rheumatoid arthritis

Biosimilars/Research | Posted 15/09/2017

Rituximab is an established anti-CD20 monoclonal antibody used for the treatment of some haematological cancers and immune-mediated diseases, such as rheumatoid arthritis (RA). CT-P10 (Truxima) is the first biosimilar of the rituximab reference product and was approved in Europe for all licensed RTX indications in February 2017 [1]. A phase I randomized controlled trial (RCT) of CT-P10 versus reference rituximab in patients with active RA demonstrated that the two drugs had equivalent pharmacokinetics after a single course of treatment and that their efficacy, pharmacodynamics, immunogenicity and safety were comparable up to Week 24 [2]. To allow comparison of CT-P10 versus reference rituximab, patients in the same phase I trial received a second course of treatment and were evaluated for efficacy, safety, pharmacokinetics, pharmacodynamics, and other clinical data for up to 72 weeks. These data demonstrate that the clinical profile of CT-P10 is comparable to reference rituximab in patients with RA over an extended treatment duration [3].

Biological drug evolution: improved awareness and pharmacovigilance required

Biosimilars/Research | Posted 08/09/2017

The safety profile of established biological drugs can alter over time following changes to manufacturing processes. However, healthcare professionals are often unaware of changes and there is a need for improved pharmacovigilance, according to a report published by researchers in Scotland, UK [1].

Rituximab biosimilar CT-P10 could save Europe Euros 90 million in its first year

Biosimilars/Research | Posted 01/09/2017

A recent publication in Advances in Therapy suggests that introducing CT-P10, a biosimilar of the anti-CD20 monoclonal antibody rituximab, would generate significant savings for European healthcare systems [1]. CT-P10 is approved by the European Medicines Agency (EMA) for all indications held by reference rituximab, including rheumatoid arthritis and haematological cancers, such as non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. Although the therapeutic benefits of anti-CD20 therapy are well established, the cost of reference rituximab is thought to create barriers to patient access [2]. It is hoped that the introduction of more affordable biosimilars will help address this issue. Gulácsi L et al. therefore quantified the potential budgetary impact of introducing CT-P10 for the treatment of rheumatoid arthritis and CD20-positive cancers in 28 European countries [1].

Biological drug evolution: inadequate short-term clinical trials

Biosimilars/Research | Posted 01/09/2017

The safety profile of established biological drugs can alter over time following changes to manufacturing processes and short-term clinical trials fail to isolate adverse events, according to a report published by researchers in Scotland, UK [1].

Adello Biologics starts phase I trial for pegfilgrastim biosimilar

Biosimilars/Research | Posted 25/08/2017

US-based biosimilars specialist Adello Biologics has started a phase I clinical trial for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

Biosimilar pegfilgrastim highly similar to Neulasta

Biosimilars/Research | Posted 18/08/2017

Canada-based Apobiologix published analytical results demonstrating the similarity of their pegfilgrastim product to the US reference product, Amgen’s Neulasta (pegfilgrastim) [1].

Real-life data supports efficacy and safety of biosimilar filgrastim

Biosimilars/Research | Posted 18/08/2017

Biosimilars of filgrastim are widely used in the prophylaxis of chemotherapy‐induced (CIN) and febrile neutropenia (FN). However, there are limited observational data on the use of granulocyte colony-stimulating factor (G‐CSF) in non‐Hodgkin’s lymphoma (NHL) and its aggressive subtypes including diffuse large B‐cell lymphoma (DLBCL).

Biosimilar trastuzumab candidate shows ‘similarity’ to Herceptin

Biosimilars/Research | Posted 11/08/2017

Results of a phase III clinical study of Celltrion’s biosimilar trastuzumab candidate CT‑P6 demonstrated the ‘similarity’ of the efficacy and safety compared to the originator biological (Herceptin) in patients with HER2+ breast cancer [1].

US prescribers’ views on the naming and labelling of biologicals

Biosimilars/Research | Posted 14/07/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey in which they asked 400 US physicians for their views on the labelling of biosimilar medicines, and a separate survey in which they asked another 400 US physicians for their views on the naming of biosimilar medicines [1]. All those surveyed were prescribers of biological medicines. The surveys were carried out in the run up to the release of guidance from the US Food and Drug Administration (FDA) on the non-proprietary naming of biological products.

Real world switching data for etanercept biosimilar Benepali

Biosimilars/Research | Posted 14/07/2017

Real world evidence from a study of etanercept biosimilar Benepali (SB4) compared to Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept) have demonstrated ‘sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with Benepali (etanercept)’, according to Biogen.

Pharmocovigilance of rituximab in Argentina

Biosimilars/Research | Posted 07/07/2017

Novex is a rituximab medicamento biológico similar (similar biological medicines) approved in Argentina. According to Argentinian regulations such products need to implement an active pharmacovigilance programme. This requires regular reporting to the Argentinian regulatory agency Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).

Trastuzumab biosimilar could reduce breast cancer treatment costs

Biosimilars/Research | Posted 30/06/2017

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

Biosimilars and sustainability

Biosimilars/Research | Posted 23/06/2017

Competition between brand-name biologicals and biosimilars has the potential to reduce future cancer costs, according to researchers from Italy [1].

Boehringer Ingelheim’s adalimumab biosimilar ‘equivalent’ to Humira

Biosimilars/Research | Posted 23/06/2017

Germany-based biologicals specialist Boehringer Ingelheim (Boehringer) announced on 14 June 2017 positive results from its pivotal phase III study of its candidate adalimumab biosimilar.

Biosimilar infliximab safe and effective in IBD

Biosimilars/Research | Posted 16/06/2017

A systematic review and meta-analysis of Celltrion/Hospira’s infliximab biosimilar, Remsima/Inflectra found it to be safe and effective in the treatment of inflammatory bowel diseases (IBD) [1].

Infliximab biosimilar coming closer to interchangeability

Biosimilars/Research | Posted 09/06/2017

Three studies presented at the Digestive Disease Week (DDW) 2017 have shown no significant differences in efficacy or safety endpoint. Two of the studies also specifically tested outcomes in patients switching from the originator infliximab product, Remicade, to the biosimilar version.

Predictive modelling of CIN prophylaxis with biosimilar filgrastim

Biosimilars/Research | Posted 09/06/2017

Granulocyte colony-stimulating factors (G-CSF) stimulate white blood cell production and as such are indicated in the prophylaxis of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Risk models of CIN/FN to date focus on predictors measured at the start of chemotherapy. Aapro and colleagues used a dynamic approach of CIN/FN risk modelling at the start of each cycle.

How the FDA regulates biosimilars

Biosimilars/Research | Posted 02/06/2017

The advent of recombinant DNA-technology ushered in the development of novel therapeutic protein products that have become mainstays of treatment regimens against cancer, inflammatory disorders and other serious diseases and conditions. Recombinant therapeutic proteins are typically large, complex molecules that are produced in cultured cells and manufactured using complex, multistep purification processes. Despite some of these products being ‘off-patent’ for years, they remain among the most expensive pharmaceuticals in the US and the world. One approach that governments across the globe have taken to reduce healthcare costs is to give regulatory authorities the ability to approve biologicals using an abbreviated licensing pathway that includes achieving the rigorous standard of demonstrating ‘biosimilarity’ with an already approved biological product.

Positive phase III results for Sandoz’s adalimumab biosimilar

Biosimilars/Research | Posted 02/06/2017

A phase III study of a proposed adalimumab biosimilar (GP2017) from Sandoz has met its primary endpoint ‘demonstrating equivalent efficacy’ to AbbVie’s Humira (adalimumab).

Biosimilars in the treatment of inflammatory bowel disease

Biosimilars/Research | Posted 26/05/2017

Inflammatory bowel disease (IBD) is mainly characterized by two chronic, relapsing, immune-mediated inflammatory diseases of the gastrointestinal tract: Crohn’s disease and ulcerative colitis. Approximately 1.4 million Americans are affected by IBD and afflicted with recurrent symptoms of bloody diarrhoea, abdominal pain, bowel obstruction, and other co-morbid conditions. The introduction of biologicals, highly complex molecules manufactured from living organisms, was a revolutionary advance in treating threatening and life-debilitating inflammatory diseases. Biologicals, particularly those that target tumour necrosis factor (TNF) signalling, have provided IBD patients with an efficacious method of treatment with regards to symptom management and mucosal healing. Nevertheless, the rising prevalence of IBD worldwide and the ever-increasing cost burden of biologicals in the healthcare industry is alarming for insurance companies, clinicians and patients.

EMA guidance for NBCDs and products approved

Biosimilars/Research | Posted 26/05/2017

The European Medicines Agency (EMA) has published reflection papers on nanomedicines and their follow-on versions [1]. It has also published a wide range of other guidance, which outlines the technical requirements to demonstrate the quality, safety and efficacy of medicines that may also be applicable to non-biological complex drugs (NBCDs), according to authors Ehmann and Pita [2].

Danish infliximab switching study shows no difference

Biosimilars/Research | Posted 19/05/2017

A study published by researchers from Denmark has found that switching from originator to biosimilar infliximab has ‘no negative impact on disease activity’ [1].

Post-marketing experience with IBD biosimilars

Biosimilars/Research | Posted 19/05/2017

The introduction of anti-tumour necrosis factor-alpha (TNF-α) monoclonal antibodies (mAbs), about two decades ago, has revolutionized the management of inflammatory bowel disease (IBD). However, they are also expensive and their cost can lead to restricted access for many patients.

Accountability, safety and competition in biologicals markets

Biosimilars/Research | Posted 12/05/2017

Regulatory systems for drug approval aim to reduce the likelihood of drug-related safety problems, but cannot fully eliminate post-marketing safety events. Such safety problems can have substantial consequences for patient’s well-being. For example, the most severe class of recalls issued by the US Food and Drug Administration (FDA) occur about once per month, and have recently been increasing in frequency [1]. Post-marketing surveillance or pharmacovigilance systems enable monitoring of and response to safety problems that may be undetected before drugs reach the general market [2]. When a safety problem occurs, successful identification of the responsible firm, or accountability, depends on the information available to the pharmacovigilance effort [3, 4].

Computer modelling for glycoengineering of biosimilars

Biosimilars/Research | Posted 04/05/2017

In order to be approved by regulatory agencies, biosimilars are required to match all pharmacological properties of the originator protein drug to guarantee efficacy and alleviate safety concerns.

Prospective study finds switching to biosimilar infliximab safe

Biosimilars/Research | Posted 28/04/2017

A study of the infliximab biosimilar Remsima has, according to the authors, shown similar ‘safety and survival’ of biosimilar infliximab Remsima compared to the originator biological Remicade [1].

Rituximab biosimilar safe in advanced follicular lymphoma patients

Biosimilars/Research | Posted 21/04/2017

A study of the rituximab biosimilar CT‑P10 has, according to the authors, ‘demonstrated’ similar pharmacokinetics (PK) and safety when administered in combination with cyclophosphamide, vincristine and prednisone (CVP) in patients with newly diagnosed advanced follicular lymphoma (AFL) [1].

Harmonization of requirements for NBCDs across regions

Biosimilars/Research | Posted 21/04/2017

Efforts are being undertaken to continuously develop and harmonize the regulatory requirements for complex medicinal products across regions. Taking this into account, authors Ehmann and Pita believe the European Union (EU) network is ready for non-biological complex drugs (NBCDs) [1].

US pharmacists’ views on the naming and labelling of biologicals

Biosimilars/Research | Posted 14/04/2017

The Alliance for Safe Biologic Medicines (ASBM) has published the results of a survey determining the opinions of US pharmacists about the naming and labelling of biosimilars [1].

Italian study compares epoetin biosimilars and originator biologicals

Biosimilars/Research | Posted 14/04/2017

Recently, extensive discussion on the opportunity offered by biosimilars for the sustainability of the National Health Services has taken place in academic and regulatory contexts. The use of biosimilars continues to be limited, and the scepticism of prescribers and patients seem to be linked to the uncertainty of the risk-benefit profile of biosimilars. In the case of epoetins, used in the management of anaemia in the nephrology and oncology settings, the results of a recent study showed no difference between biosimilars and originators on relevant effectiveness and safety outcomes [1].

Pharmacovigilance of biologicals in Denmark

Biosimilars/Research | Posted 19/08/2016

As a result of the increasing use of biologicals and biosimilars in Denmark, the Ministry of Health (MoH) in partnership with the country’s regulatory agency has set up an action plan to monitor biologicals and improve pharmacovigilance, as well as to improve understanding among healthcare professionals and patients [1].

Filgrastim follow-on biological has similar efficacy and safety in breast cancer patients

Biosimilars/Research | Posted 07/04/2017

A study comparing two filgrastim formulations for controlling chemotherapy-induced neutropenia has reported similar efficacy, safety and non-inferiority of the biosimilar [1].

Marketing authorization for NBCDs in the EU

Biosimilars/Research | Posted 07/04/2017

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU and this also includes non-biological complex drugs (NBCDs).