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Europe's biosimilars market – the next three years will be crucial

14 May 2015 Brendan Melck

The European Generics Association (EGA) - or to give it its full title, the European Generic and Biosimilar Medicines Association - held its 13th annual European biosimilars conference on 23-24th April in London. Developing a sustainable European biosimilars market was a major focus of the conference, as well as the potential cost of failing to do so.

In his speech opening the conference, Nick Haggar, the EGA's president and head of Western Europe Middle East and Africa for Sandoz, the generics division of Swiss pharma major Novartis, emphasised that the biosimilars market was going to heat up considerably in the next three years. Biosimilar versions of a number of major biologic drugs used in the treatment of cancers and rheumatic diseases are expected to complete their development and potentially come on to the market, including Roche (Switzerland) drugs Herceptin (trastuzumab) and MabThera (rituximab), and AbbVie (US) drug Humira (adalimumab). In order to ensure the sustainability of public healthcare systems, in the context of ageing populations and growing incidence of chronic diseases, it will be essential to harness to potential of biosimilars to deliver savings, so that greater numbers of patients can be treated with these medicines.

Arrival of new innovative biologics makes creation of 'headroom' essential
Some speakers drew attention to the fact that the majority of growth in the sales of biologic medicines is focused in the US and the EU, where specialty pharmaceutical products are responsible for most of the market growth. In this context, they highlighted concerns about the arrival of new biologics in disease areas traditionally treated with small-molecule drugs, particularly the new class of cardiovascular drugs, PCSK9 inhibitors, and the associated cost explosion which has been predicted. Making savings from biosimilars of established biologics will be essential to create financial 'headroom' for healthcare systems to fund new treatments coming on to the market.

Warning of potential costs of failure to ensure sustainable biosimilars market
Other speakers underlined the benefits to payors of a sustainable biosimilars market, which could contribute to the sustainability of public healthcare systems. At the same time, he emphasised that all four key stakeholder groups - physicians, payors, patients and industry - had to be brought onside and receive the benefits of such a biosimilars market. Delegates focused on the importance of education in helping to achieve greater uptake, with education to be directed at a range of stakeholders - doctors, payors and patients. They stated that switching from an originator biologic to a biosimilar should be a physician-driven decision in the early stages of a biosimilar's presence on the market, while once it has gained their confidence, and that of their patients, it may become a decision taken together with other stakeholders. The summary is worth noting - the question is not what are the benefits of a well-functioning biosimilars market, but what is the cost of not having one.

Belgium, Ireland and France lag behind on biosimilar penetration
With this in mind, it was instructive to note how the penetration in EU member states of well-established biosimilars such as filgrastim, erythropoietin and human growth hormone (HGH) varied quite strongly; this showed that in most EU markets, biosimilar versions of at least one or two of these products had gained a substantial, and sometimes almost total market share, in terms of treatment days. The major exceptions were Belgium, Ireland and France. Didier Laloye, the general manager of Hospira in France, speaking on behalf of France's generics association Gemme, highlighted the regulatory challenges which faced biosimilars producers in the country, not least from the sheer complexity of the many organisations involved in regulating the sector. This contrasts with Portugal, where Infarmed has broad-ranging responsibilities relating to most aspects of pharmaceutical regulation - its vice president Helder Mota-Felipe showed in his presentation how uptake of these established biosimilars had increased significantly in Portugal in the past few years. No doubt budgetary pressure from the troika played its part here, too.

In the coming years, it can be expected that more intensive efforts will be made to take advantage of the potential savings offered from biosimilars. Biosimilar infliximab has already made major inroads in Norway and Poland, where the patent expired earlier than major European markets, with the biosimilar version having attained 51% of the Norwegian market by volume by March 2015

Poland's 'automatic substitution' guidelines influence greater biosimilar penetration
The case of Poland was also highlighted over the quick uptake of biosimilar infliximab in the country, primarily due to its tendering system. Another reason is the Polish Ministry of Health's active encouragement of automatic substitution (assuming interchangeability) at all treatment stages; according to a recent statement by Poland's Employers' Union of Innovative Pharmaceutical Companies (Infarma), automatic substitution is already happening public hospitals in Poland - which Infarma criticised strongly, pointing to the fact that in no EU country is it required under the law to practice such substitution (this is not formalised into law in Poland, either, although the MoH encouraged it in a position statement published last year).

Growing confidence + budget concerns = greater biosimilars uptake
Other EU countries are likely to be more circumspect when it comes to interchangeability with regard to biosimilar mAbs. However, as suggested by the upsurge in the take-up of the established biosimilars in the EU, even in countries such as Italy, where scepticism was rife, growing confidence for the products will combine with growing concern for the sustainability of public healthcare systems to ensure that a competitive market is established for patent-expired mAbs.

Brendan Melck is a life sciences analyst for IHS
Posted 14 May 2015



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