Biosimilars

Mylan and Biocon submit pegfilgrastim biosimilar to EMA

Biosimilars/News | Posted 19/08/2016

Mylan and Biocon announced on 21 July 2016 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the European Medicines Agency (EMA).

Bevacizumab similar biologics launched in India

Biosimilars/News | Posted 19/08/2016

Generics makers Reliance Life Sciences (Reliance) and Hetero have both launched similar biologics of Roche’s blockbuster cancer therapy Avastin (bevacizumab) in India.

Evolution of biosimilars in developed and developing countries

Biosimilars/Research | Posted 19/08/2016

The development of biologicals has experienced continuous growth over the past three decades. The expiration of patent protection for many biologicals has led to the development of biosimilars in many countries around the world. This paper reviews the literature on biosimilars and covers their therapeutic status, clinical trials, approved biosimilars and regulatory guidelines in Japan, South Korea and Malaysia [1].

Biosimilars: the benefits need to be communicated

Biosimilars/Research | Posted 12/08/2016

Extrapolation may be the most contentious issue of biosimilar development, but it is also its single greatest benefit, says Dr Martina Weise of the Federal Institute for Drugs and Medical Devices in Germany.

Samsung Bioepis adalimumab biosimilar submitted to EMA

Biosimilars/News | Posted 12/08/2016

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 18 July 2016 that its adalimumab biosimilar candidate, SB5, had been accepted for review by the European Medicines Agency (EMA).

Sandoz plans to launch five more biosimilars by 2020

Biosimilars/General | Posted 12/08/2016

Sandoz, the generics division of Novartis, has announced plans for five major global biosimilar launches by 2020.

Biosimilars: clinicians and regulators need to talk

Biosimilars/Research | Posted 05/08/2016

In Europe, there is a clear gap between the regulatory decisions that govern biosimilar approval and the recommendations of medical societies. The fact that the views of medical societies, whose members are the physicians that will prescribe biosimilars, disagree with those of regulators, may hold back biosimilar uptake.

FDA rejects Sandoz’s biosimilar pegfilgrastim application

Biosimilars/News | Posted 05/08/2016

Novartis disclosed on 19 July 2016 that the application by its Sandoz unit to market a biosimilar version of pegfilgrastim has been rejected by the US Food and Drug Administration (FDA).

Pure red cell aplasia in a CKD patient after treatment with epoetin zeta

Biosimilars/Research | Posted 05/08/2016

Authors from the Versilia and Manzoni Hospitals in Italy report the case of a patient who developed pure red cell aplasia (PRCA) following subcutaneous administration of epoetin zeta, which is one of the two biosimilars of epoetin alfa licensed in Europe [1].

FDA advisors recommend approval of Sandoz’s etanercept biosimilar

Biosimilars/News | Posted 29/07/2016

US Food and Drug Administration’s (FDA) advisors have voted to recommend the approval of Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).

Biosimilars of tocilizumab

Biosimilars/General | Posted 29/07/2016

Last update: 4 December 2020

Tocilizumab is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells.

The economic impact of biosimilars in the US

Biosimilars/Research | Posted 29/07/2016

Biologicals are large molecule compounds used to treat rare or complex diseases. Between 2013 and 2014, spending on specialty drugs, including biologicals, increased 32.4%, while spending on small-molecule drugs increased by just 6.8%. By 2016, eight of the 10 top-selling drugs are expected to be biologicals.

Positive clinical data for three anti-TNF-α biosimilars

Biosimilars/Research | Posted 29/07/2016

Results of studies of three biosimilars from Samsung Bioepis, Benepali (etanercept), Flixabi (infliximab) and candidate biosimilar SB5 (adalimumab), have shown ‘comparable outcomes with regards to both the efficacy and safety of treatment’ when compared to their respective reference products, according to the company [1-3].

Doctors want more details in biosimilars labelling

Biosimilars/Research | Posted 01/07/2016

In the European Union (EU), labels (Summaries of Product Characteristics, SmPCs) for biosimilars and their reference products are, in many instances, almost identical despite different data requirements for the authorization of biosimilars.

Mylan presents comparability data for trastuzumab biosimilar

Biosimilars/Research | Posted 01/07/2016

Generics giant Mylan Pharmaceuticals (Mylan) presented robust data from its biosimilar trastuzumab programme at the American Society of Clinical Oncology (ASCO) Annual Meeting ASCO 2016 held in Chicago, USA on 3–7 June 2016.

Real-world safety data for epoetin alfa biosimilar

Biosimilars/Research | Posted 01/07/2016

A 2-year post-marketing study of the epoetin alfa biosimilar Binocrit has found the biosimilar to be safe in daily clinical practice, according to the authors [1].

Health Canada approves Inflectra biosimilar for extra indications

Biosimilars/News | Posted 24/06/2016

US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s medicines regulator, Health Canada, in three extra indications.

Biosimilar rituximab in biological naïve rheumatoid arthritis patients

Biosimilars/Research | Posted 24/06/2016

Cost remains a major constraint in the use of originator biologicals in rheumatology in developing countries, paving the way for ever increasing usage of biosimilars. However, apart from the cost, their efficacy and safety are of tremendous interest to clinicians in both developing and developed worlds.

Insulin biosimilar meets primary endpoint in phase III studies

Biosimilars/Research | Posted 24/06/2016

US pharma giant Merck announced on 13 June 2016 positive results from two phase III studies evaluating its insulin glargine biosimilar (MK-1293).

Improvement in uptake of biosimilars in Spain

Biosimilars/Research | Posted 17/06/2016

Author Ainhoa Aranguren Oyarzábal and colleagues from the Madrid Health Service (MHS), Spain found that there has been an increase in the uptake of biosimilars in Spain since indicators were introduced [1].