Biosimilars/Research
Positive clinical data for three anti-TNF-α biosimilars
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].
Mylan presents comparability data for trastuzumab biosimilar
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.
Epoetin alfa biosimilar effective in treating anaemia
Authors of a post-marketing study of the epoetin alfa biosimilar Retacrit say that the biosimilar is effective and well tolerated in treating chemotherapy-induced anaemia (CIA) [1].
Evolution of biosimilars in developed and developing countries
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
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
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
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
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
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
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.
