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Countering points made in biosimilars piece

The insight article by Alan Cassels ‘Why biosimilars should be interchangeable with biologics’ (Clinical Pharmacist 2017;9:2) provides a great opportunity to clarify some key points. I would like to counter some of the points made in Cassels’ piece — criticisms he says are used to slow down or derail the use of biosimilar products.

Biosimilars have been approved according to the established international regulatory standards (which the European Medicines Agency pioneered) and are demonstrated to be safe and efficacious. That is the point of the regulation. Although it may be tempting to claim that the biopharmaceutical industry is aiming to discredit biosimilars, it is simply not the case. Our industry has contributed to the biosimilar regulatory standards and we have set out support for biosimilars. In the UK, we have been partners in the work led and co-ordinated by NHS England “to improve clinician confidence and clarify understanding amongst decision makers”, including the document ‘What is a biosimilar medicine?’

Developing and manufacturing biosimilars is a challenging process, and highly skilled biopharma companies are investing in these important medicines. Although the first biosimilars in Europe were made by predominantly generics and biosimilars companies (including Novartis’ subsidiary, Sandoz), the manufacturers of biosimilars now include Amgen, Pfizer, Lilly, Biogen Idec, Boehringer Ingelheim and others.

This article concludes that the participation of these research-led biopharma companies is just a defensive strategy to hedge their bets. By anyone’s standards, examples of investment of more than $1bn in biosimilars seems a bit of an expensive hedge. Moreover, these companies are sponsoring many of the current biosimilars under review and recently approved.

The article does not define interchangeability clearly, and that term holds different meanings around the world. In Europe, interchangeability is defined as “the medical practice of changing one medicine for another that is expected to achieve the same clinical effect in a given clinical setting and in any patient on the initiative, or with the agreement of the prescriber”. The guidance focuses on the decision-making of doctors because they can judge the benefits and risks of medicines and the needs for any given patient, and change treatment on the basis of the evidence and opportunity in that setting.

Automatic substitution is not needed to deliver savings from the introduction of biosimilars. Competition is what delivers savings, and competition is just as effective when doctors and patients are given the means to assess the opportunity and make appropriate changes. Competition also needs to be designed in procurement practices and factors that support decision making, like effective information and metrics.

This has been a clear focus for the NHS England National Programme Board for Biosimilars and NHS England Medicines Optimisation, where criteria include efficacy, safety, sustainability and efficiency. The evidence of how Europe has benefited from savings through biosimilar market entry has been assessed by IMS for the European Commission, and robustly challenges the arguments in this article.

Additionally, doctors and patients have a central role to play in treatment decisions. Education and training for healthcare professionals and patients are a priority for the work we are pursuing through the NHS England National Programme Board for Biosimilars. Rather than dismissing patients and doctors’ lack of knowledge or lack of judgement, the stakeholders contributing to this programme board (including the Association of the British Pharmaceutical Industry) believe firmly that a strong foundation for biosimilars lies in genuine education and dialogue.

And finally, Europe is still leading the way on biosimilars. The United States is only now having its first biosimilars (with the fourth approval in September 2016) compared with the 15 biosimilar molecules in nine different molecular classes that have been approved in Europe, and currently marketed under 23 distinct brands. The lesson we need to share is the value of collaborating across industry, healthcare systems, regulatory and health technology assessment bodies, professional societies and patients to provide if not the “one version of the truth” (because science keeps us guessing) for biosimilars, at least the “one source for the truth”.

Virginia Acha

Executive director – research, medical and innovation

Association of the British Pharmaceutical Industry

Citation: Clinical Pharmacist DOI: 10.1211/CP.2017.20202218

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