Biosimilars/Research

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.

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].

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.

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.

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].

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.