Brussels, 31 October 2013

In their joint response to the European Medicines Agency (EMA) consultation on its draft revised guideline on biosimilars, ISDB and the Medicines in Europe Forum argue that the costly requirements imposed on biosimilars primarily serve to defend companies' intellectual property, not public health.

> Click here to download the joint response by the Medicines in Europe Forum and ISDB to the consultation (pdf, 267 Ko)

Key points

• The context surrounding the current discussions on "biosimilars", i.e. copies of biotechnology-derived medicinal products, is one of pharmaceutical companies pushing for greater protection of their intellectual property. Companies that market novel originator medicinal products are striving to prolong their monopoly for as long as possible, thereby delaying the market introduction of cheaper competing copies.
• All biological medicinal products exhibit variation related to their methods of production, even between different batches of the same originator product. Drug regulatory agencies should therefore impose the same requirements on companies manufacturing an originator product (for example when the manufacturing process or manufacturing site is changed) as on companies manufacturing biosimilars.
• The comparability of an originator medicinal product and a copy can usually be assessed using analytical methods and, if necessary, in bioequivalence studies. This is after all the method routinely used to assess the comparability of two batches of the same proprietary medicinal product.
• The main argument put forward by both pharmaceutical companies selling originator products and drug regulatory agencies to justify the requirement to conduct clinical and preclinical studies before a biosimilar can be marketed is the risk of differing immunogenicity between the biosimilar and the originator, for example due to differences in their glycosylation profiles. Yet in the vast majority of cases, these slight differences in immunogenicity will have no clinical impact: their efficacy and adverse effect profile will be similar.
• Specific preclinical and clinical studies provide a false sense of security. The results obtained will always be the same: the two medicinal products have equivalent harm-benefit balances and can be used for the same purposes as long as one remains attentive to the emergence of any safety signals, as with any medicinal product.
• In France, biosimilars are about 20% to 30% cheaper than the reference product. Their uptake is held back by various systemic barriers in Member States: some require biological medicinal products to be prescribed by their brand names, most do not allow pharmacists to substitute biological medicinal products with a biosimilar, etc.
• Ten years after the invention of "biosimilar" status in Europe, it remains an unattractive prospect for pharmaceutical companies and is having little impact on Member States' spiralling healthcare costs.
• As of 2013, the EMA's guidelines on biosimilars seem to be shifting towards a more pragmatic approach, dispensing with certain clinical trials that rather than help demonstrate "biosimilarity" are, in reality, used to delay the market introduction of copies.  
• The EMA could also encourage the development of useful biosimilars by upholding the integrity of international nonproprietary name (INN) system; by adopting a responsible policy on access to data; by creating a centralised list of groups of biosimilar medicinal products; and by developing proactive pharmacovigilance.

©Medicines in Europe Forum and ISDB October 2013

> Click here to download the joint response by the Medicines in Europe Forum and ISDB to the consultation (pdf, 267 Ko)