Biosimilars

Biologicals: characteristics that make them unique and special

Biosimilars/Research | Posted 01/04/2016

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*.

Biocon receives Japanese approval for insulin glargine biosimilar

Biosimilars/News | Posted 01/04/2016

India-based biologicals specialist Biocon announced on 28 March 2016 that it had received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its insulin glargine biosimilar.

IGBA opposes WHO biological qualifier

Biosimilars/General | Posted 25/03/2016

The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [1]. However, not everyone agrees with their proposal.

Biosimilars: a new challenge in the current pharmacology

Biosimilars/Research | Posted 25/03/2016

In a review of biosimilars in rheumatology author José M Serra López-Matencio and colleagues from the Universidad Autónoma, Madrid, Spain discuss issues surrounding biosimilars*.

Epoetin alfa biosimilar effective in treating anaemia

Biosimilars/Research | Posted 25/03/2016

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].

Pharmacovigilance for mAbs

Biosimilars/Research | Posted 18/03/2016

Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland in his paper discusses questions related to monoclonal antibody (mAb) biosimilars [1]. One question addressed was that of pharmacovigilance for mAbs.

US doctors poised to prescribe biosimilars

Biosimilars/General | Posted 18/03/2016

A survey of specialists in the US has found that nearly half of them expect to prescribe biosimilars to treatment-naïve patients.

Benefits and concerns related to biosimilars

Biosimilars/Research | Posted 18/03/2016

As patents of the first introduced biological therapeutics in oncology have begun to expire, competing pharmaceutical companies are allowed to produce and market the same protein as the originator agent. This follows the pattern of the development of generics. However, biosimilars are fundamentally different from generics. Particularly in the field of oncology, the introduction of monoclonal antibodies has resulted in spectacular therapeutic advances by increasing the cure rate of early cancers and prolonging survival. Similar advances have occurred in rheumatology, haematology, neurology and other fields. Most therapeutic biologicals are monoclonal antibodies with molecular weights of around 140,000 Daltons [1]. Other peptides include hormones, growth factors and vaccines [2]. Most of those products are expensive and their broad application drains the financial resources of healthcare systems. Therefore, the development of biosimilars is expected to be mutually beneficial for both the pharmaceutical industry and society: pharmaceutical companies may enter a lucrative business, whereas payers reasonably expect lower prices for these costly but essential drugs.

Merck Group starts phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 18/03/2016

Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.

Extrapolation of indications for mAbs

Biosimilars/Research | Posted 11/03/2016

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].