Biosimilars

Biosimilar pipelines for South Korean firms: Chong Kun Dang, DM Bio and HK inno.N

Biosimilars/General | Posted 31/05/2021

South Korea is becoming a more and more important spot on the map when it comes to biosimilars. Although Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are leading the way in Korea and worldwide, other Korean companies, such as Chong Kun Dang Pharmaceutical (Chong Kun Dang), DM Bio (joint venture between Dong-A ST and Meiji Holdings) and HK inno.N (previously CJ Healthcare), are also expanding their biosimilar pipelines.

Are regulatory and scientific reporting biosimilar QAs consistent and complimentary?

Biosimilars/Research | Posted 21/05/2021

Questions have been raised regarding the consistency and complementarity of reporting biosimilar quality attributes between regulatory and scientific communities. For the first time, a study published in Biologicals [1] has found that while the reporting of quality attributes (QAs) by these two sources lacks consistency, overall, they do complement one another.

Approved biosimilars for South Korean firms: Celltrion and Samsung Bioepis

Biosimilars/General | Posted 21/05/2021

Korean companies, such as Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture), are becoming more and more important both in the country and worldwide when it comes to developing biosimilars.

Australia approves adalimumab biosimilar Abrilada

Biosimilars/News | Posted 21/05/2021

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA), has approved the adalimumab biosimilar Abrilada (PF-06410293).

Role of European patient associations when informing patients about biosimilars

Biosimilars/Research | Posted 21/05/2021

Biosimilars contribute to more sustainable healthcare systems by generating competition in the off-patent biologicals market. The extent to which the benefits of competition in the marketplace are exploited depends, of course, on their use in clinical practice. One of the factors determining adoption in clinical practice is the acceptance by healthcare providers (HCP) and patients. Often, a lack of acceptance comes down to shortcomings in knowledge and understanding about biosimilars. Educating patients about biosimilars is therefore considered as one of the key elements for a successful market for off-patent biologicals and biosimilars.

EC approves bevacizumab biosimilar Abevmy

Biosimilars/News | Posted 14/05/2021

On 26 April 2021, India-based biologicals specialist Biocon Biologics (Biocon) announced that its bevacizumab biosimilar, Abevmy (MYL 1402O), which it co-developed with US-based drugmaker Viatris (formerly Mylan), had received European Commission (EC) approval.

Canadian provinces expand their use of biosimilars

Biosimilars/General | Posted 14/05/2021

New Brunswick has become the third Canadian province to implement a biosimilar switching policy. The province of Alberta has also expanded its switching programme to include biosimilars of the anti-inflammatory treatment adalimumab (Humira).

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.

Cost-savings from higher biosimilar uptake and more appropriate use of ESAs

Biosimilars/Research | Posted 14/05/2021

Chronic kidney disease (CKD) is a growing public health issue worldwide. In Italy, the prevalence of CKD is 7.5% in men and 6.5% in women [1]. In Italy, the annual direct costs of management for patients on dialysis were estimated to be around €30,000 for peritoneal dialysis and €44,000 for haemodialysis [2]. Erythropoiesis-stimulating agents (ESAs) have a significant economic burden in CKD as they are widely used to treat CKD-related anaemia; biosimilars can guarantee a 20%–30% saving on ESA purchase costs in CKD patients [3].

Safety of switching between rituximab biosimilars in cancer

Biosimilars/General | Posted 07/05/2021

In more than 10 years of clinical experience, no substantial clinical and safety differences have been detected among biosimilars and their already approved biologicals [1]. However, concerns are raised with respect to the practice of switching in patients already treated with a specific biological product (either reference or biosimilar) [2].

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.

Samsung Bioepis launches Hadlima in Australia and Canada

Biosimilars/News | Posted 07/05/2021

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 29 March 2021 that it had now launched its adalimumab biosimilar, Hadlima (SB5), in Australia and Canada.

Insurer formularies increase complexity for healthcare providers

Biosimilars/General | Posted 07/05/2021

An assessment of insurer formularies for pegfilgrastim in the US suggests that payer-imposed preferences increase complexity when pharmacists and physicians are choosing which version of a drug to stock and administer.

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].

LG Chem gains approval for adalimumab biosimilar in Japan

Biosimilars/News | Posted 30/04/2021

Japan-based LG Chem (formerly LG Life Sciences) announced on 23 March 2021 in a public filing that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for 20 mg, 40 mg and 80 mg syringe, and 40 mg pen formulations of its adalimumab biosimilar, Adalimumab BS MA (LBAL).

Rheumatoid arthritis treatments in Australia

Biosimilars/General | Posted 30/04/2021

Analysis of the treatment landscape for rheumatoid arthritis in Australia shows that AbbVie’s Humira (adalimumab) and Pfizer’s Enbrel (etanercept) together make up half of total sales.

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.

EC approval for bevacizumab biosimilar Alymsys/Oyavas

Biosimilars/News | Posted 23/04/2021

The European Commission (EC) granted marketing authorization for the bevacizumab biosimilar Alymsys/Oyavas (MB02), on 31 March 2021. The biosimilar is developed by mAbxience, a biopharmaceutical firm with offices in Spain, Argentina and Switzerland.

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.

Biosimilars of enoxaparin sodium

Biosimilars/General | Posted 23/04/2021

Enoxaparin sodium is an anticoagulant medication (blood thinner). It is used to treat and prevent deep vein thrombosis (DVT) and pulmonary embolism (PE) including during pregnancy and following certain types of surgery. It is also used in those with acute coronary syndrome (ACS) and heart attacks.

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].