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SP0038 How Can The Proliferation of Biosimilars Impact on R&D and Quality?
  1. R. Van Vollenhoven
  1. Amsterdam Rheumatology and Immunology Center ARC, Amsterdam, Netherlands

Abstract

Almost twenty years ago, the advent of biological therapies changed the world of rheumatology in three ways: clinical results became dramatically better; treating patients became more complicated but also much more rewarding; and the price of antirheumatic therapy skyrocketed. The advent of biosimilars that has started recently is viewed by many as an important correction of the third aspect; it will also add a little to the complexity of treating patients; but by definition, it will not make clinical results any better at the individual patient level: “bio-similar”.

Certainly, making antirheumatic therapy sustainable at the societal level is a laudable goal, if not for the individual physician, then at least for the health care system as a whole. But are there any downsides to the introduction in practice of biosimilars?

Part of the answer to that question can be understood if one asks another question: why are biosimilars less expensive than the originator products? An important part of the answer to that question is that the manufacturer of biosimilars can avoid the very large investments in research and development (R&D) that are needed for developing originator products. But this is then also the answer to the first question: the savings generated by biosimilars are to a significant extent taken from the R&D budgets in pharmaceutical industry. For those who are concerned about the long-term perspectives of health care from the societal point of view this should be a sobering thought.

A second concern is generated by the increasing number of biological products on the market, including both originator and biosimilar products. These medications are by their nature complex mixtures of proteins, the quality control of which is an extremely demanding task. The agencies charged with overseeing these processes will have to adjust to a reality where, for the treatment of RA alone, nine approved originator products will co-exist with easily as many biosimilar products, some of which are manufactured in several different places around the globe and transported across continents under varying physical conditions. To maintain the highest possible level of quality under these circumstances will be a daunting task for these agencies.

Biosimilars are now a fact of rheumatological life. Neither of the two concerns described here should be a reason not to use biosimilars when it would be medically appropriate to do so. But for those who are charged with setting health-care priorities, enthusiasm over the shorter-term financial gains with biosimilars should be balanced with prudence in view of the longer-term perspectives for future generations of patients.

Disclosure of Interest R. Van Vollenhoven Grant/research support from: AbbVie, Amgen, BMS, GSK, Pfizer, Roche, UCB, Consultant for: AbbVie, Biotest, BMS, Celgene, Crescendo, GSK, Janssen, Lilly, Merck, Novartis, Pfizer, Roche, UCB, Vertex

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