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How the biosimilars market is changing

Access to high quality medicine at affordable prices without jeopardizing patients’ health is one of the key challenges in developed countries where rising life expectancy and growing average age puts pressure on national healthcare systems. Biosimilars represent a class of medicinal products that seem to be attractive in tackling this challenge. However, market acceptance of biosimilars in general is still low.

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*.

Biosimilars: a new challenge in the current pharmacology

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

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

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.

Benefits and concerns related to biosimilars

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.

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].

Beyond biosimilarity

The advent of monoclonal antibody (mAb) biosimilars has raised a series of questions in the healthcare community. Just a few of these questions were discussed by Professor Pierre Michetti, a gastroenterologist at the Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland [1]. 

Efficacy and safety of biosimilar infliximab compared to other biologicals in rheumatoid arthritis

In the paper by Baji et al. [1], the authors carried out a meta-analysis to compare the efficacy and safety of biosimilar infliximab and other available biologicals for the treatment of rheumatoid arthritis (RA), namely abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab and tocilizumab. The analysis compared the recommended doses of biological disease-modifying anti-rheumatic drugs (DMARDs) indicated in RA.

Extrapolation of indications in biosimilars: infliximab

Physicians may not be well informed about the scientific concept underlying the principle of extrapolating* indications for biosimilars. This in turn may lead them to distrust biosimilars, leading to a lower than expected uptake in Europe, especially in extrapolated indications. Members of the European Medicines Agency’s (EMA) Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) address these concerns using extrapolation of indications in biosimilar infliximab as an example [1].