Biosimilars are follow-on biologics which can be introduced in the market after patents of the originator biologic medicine (reference product) have expired. Contrary to small molecule generics where the active ingredient is an identical copy of the referenced originator medicine, biosimilars are highly similar to the reference product but not identical as their large molecules are produced from living organisms. The European Union (EU) and the European Medicines Agency (EMA) have been the leader in the development of a regulatory framework for biosimilars since 2004 when the legal framework for their review and development was established. Based on this framework, the EMA has developed and refined over time a comprehensive set of regulatory guidelines based on which biosimilar applications are reviewed and approved or rejected. Omnitrope® (somatropine), a human growth hormone, was the first biosimilar approved by the European Commission (EC) in 2006. As of July 2019, 54 biosimilars of 16 originator biologic medicines have a marketing authorisation. Of those 54 approved biosimilars brands, 13 brands are duplets making the number of approved distinct biosimilars 48. A further 7 approved biosimilar brands have withdrawn their marketing authorisation for non-safety related reasons.Biologic medicines, i.e., medicines developed from recombinant DNA, have revolutionised patient care since the 1980s and roughly 25% of all new medicines approved in recent years and in development today are biologics. With this scientific revolution, the share of biologics of the global pharmaceutical market in terms of sales is approaching 25%. As the vast majority of biologics under development being specialty medicines primarily in the fields of oncology and immunology as well as orphan drugs , their share of the total pharmaceutical market is expected to continue to grow in the future. Given their complexity and the investment needed to meet ever more stringent regulatory and payer requirements combined with the growing demand for new treatments of an ageing population, the cost of these medicines and the burden on governments and insurance companies in Europe and North America in particular is expected to continue to grow.
Originator medicines’ exclusivity rights, i.e., patents are granted to allow innovator companies to earn a return on their investment as well as to fund future research into novel and advanced treatment solutions. Like in the case of small molecule generics which become available following the expiry of originator patents, the introduction of biosimilars broadens treatment choices for physicians and their patients and by increasing competition reduces health care expenditure since biosimilars are introduced and available at a lower price which tends to force originator biologics to also reduce their prices to remain competitive. Due to its global leadership in biosimilar regulation and approvals, the biosimilar market in Europe has been the largest market to date, representing approximately 60% of the global biosimilar market and growing consistently year over year. As a result, European countries with their diverse healthcare systems and their experience to date serve as real world examples of different approaches of biosimilar policies to build an efficient and sustainable biosimilar market and thus offer an opportunity for other countries to learn and to avoid mistakes which may put short but in particular long-term savings at risk.
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