EGA Press Release

Thursday, 18 May 2006

BIOSIMILAR PRODUCTS: A REALITY IN EUROPE

Speakers at the opening sessions of the 4th Annual EGA Symposium on Biosimilar Medicines in London today welcomed the European Commission’s recent approval of two biosimilar products as vindication of their belief in the ability of science to demonstrate comparability. Dr Tim Oldham, chairman of the EGA’s Biotechnology and Biosimilar Committee stated: “The EGA welcomes the European Medicine Agency’s interpretation of the science underpinning the applications as demonstrating ‘equivalent therapeutic effect’ to the reference product.”

Market authorisation was granted for the human growth hormone replacement product Omnitrope on 12 April 2006, making it the EU’s first biosimilar product to be approved. In its European Public Assessment Report (EPAR), the EMEA stated that:

“Omnitrope is a ‘biosimilar product’: this means that Omnitrope is similar to a biological medicine already authorised in the EU (also known as the ‘reference medicine’). Omnitrope has been compared to and matches the reference medicine (Genotropin) in terms of quality (how it is made), safety (for example the side-effects that can occur when receiving treatment are similar), and effectiveness.”

The report goes on to state that, “The effectiveness of Omnitrope has been shown to be equivalent to that of Genotropin.” A second biosimilar product, Valtropin, was authorised by the Commission on 24 April in exactly the same terms.

But while its faith in science and in European regulators has been vindicated, the European biosimilar industry remains concerned that this new generation of affordable medicines may not reach patients as quickly as possible. Greg Perry, Director General of EGA emphasised that “the European biosimilar industry is very anxious about an effort to multiply the number of unnecessary barriers that must be hurdled before patients and healthcare systems can have access to high quality, lower cost versions of these life-saving medicines.”

The EGA is specifically concerned that:

1. delays in the review of WHO guidelines on the naming of proteins are creating confusion over naming conventions. This could lead to the EMEA refusing to grant the same INN name to biosimilars as given to the reference product, despite precedent and sound science confirming that this is the correct path to take.
2. moves by innovator companies could require that a series of mechanisms be applied specifically to biosimilars to assure the traceability of the products to patients. This could significantly restrict access to biosimilars and increase the cost of delivering them to market. Existing monitoring processes and procedures (and associated improvement initiatives) should apply to all biopharmaceuticals and other medicines in the interest of patient safety.
3. the hurdles of pricing approval, reimbursement status and substitutability might be raised higher than those currently in place for generics, despite the clear statements of therapeutic equivalence in the assessment reports (EPARs) for biosimilars.

Dr Oldham and Mr Perry both concluded by congratulating the European medicines authorities for their initiatives at the EMEA to communicate to healthcare professionals and patient groups throughout Europe about the rigour and discipline of the approval processes. “And,” said Dr Oldham, “we would like to thank both the European Commission and the EMEA for their participation at the EGA Biosimilars Workshop and at the Paris EMEA/DIA meeting, along with all other stakeholders present.”

• Read the FAQ on Biosimilars.

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