Biosimilars/Research
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.
Insulin biosimilar meets primary endpoint in phase III studies
US pharma giant Merck announced on 13 June 2016 positive results from two phase III studies evaluating its insulin glargine biosimilar (MK-1293).
Prescribing similar biotherapeutic products in Latin America
Prescribing practices vary across different countries in Latin America and reveal gaps in understanding and in the use of distinguishable names for biologicals [1].
European regulatory pathways for biosimilars
The European regulatory pathways for biosimilars were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.
Extrapolation of indications for mAbs
Monoclonal antibody (mAb) biosimilars have recently entered the market, raising questions in the healthcare community. One of the questions discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, was that of extrapolation of indications for mAbs [1].
Biologicals: characteristics that make them unique and special
The unique characteristics of biologicals were discussed in a review of biosimilars in rheumatology by author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain*.
