EGA Press Release

Thursday, 2 September 2010

EGA CALLS FOR A WORKABLE GUIDELINE FOR BIOSIMILAR MONOCLONAL ANTIBODIES AND A CONSISTENT SCIENTIFIC GLOBAL APPROACH TOWARDS BIOSIMILAR MEDICINES

In his opening address to the 8th EGA International Symposium on Biosimilar Medicines today in London, EGA Director General Greg Perry praised the EU for continuing to inspire the rest of the world regarding the development of scientific biosimilar guidelines.

“If healthcare systems are to continue to function long-term”, he said, “we must address the importance of biosimilar monoclonal antibodies next. Science for monoclonal antibodies is already here today and our industry is expecting a workable guideline”. Addressing a large audience of some 200 participants, including over 40 European and international regulators, Mr Perry said, “As regulations fall into place around the world, there is a need to reach a global agreement on criteria and guidelines for biosimilar medicines in the interest of patients and the better availability of high-quality medicines.” Mr. Perry stressed that a thorough comparability exercise with the reference product is essential to demonstrate that the biosimilar medicine matches its reference product in terms of quality, safety and efficacy and to reassure patients and healthcare professionals. He also emphasised that the intention of the 2004 EU pharmaceutical legislation was to introduce a legal basis for the approval of similar biological products designed to compete with existing reference products.

2010 is also the year of the finalisation of the WHO guidelines on the evaluation of similar biotherapeutic products, which are founded on the same basic scientific principles as in the EU. “This is an important step towards a global, harmonised, regulatory approach,” Mr. Perry emphasised.

With progress in the U.S., Australia, Canada, Japan, Turkey and other countries around the world already armed with a regulatory framework for biosimilar medicines, the time is approaching to undertake a benchmarking exercise. A consistent, scientific global approach is essential to move towards true global development for biosimilar medicines. This goal is inspired by ethical and scientific principles as well as economic considerations, and will have a significant positive therapeutic impact for millions of patients living with life-threatening and chronic diseases.

Over the past year, there have additionally been several milestone developments for our industry. FDA approved the first generic enoxaparin, a biosimilar filgrastim was put on the substitution list in Norway and NICE in the UK included a biosimilar product for the first time in its assessment procedure.

One major negative development has recently overshadowed the positive trend for biosimilar medicines, namely the European Commission’s recent interpretation regarding the handling of duplicate marketing authorisations in the Centralised Procedure. Duplicate applications, which are needed to ensure greater availability of biosimilar medicines, are now not allowed for companies belonging to the same group. “This constitutes also a barrier to trade and will slow down the dynamic of market penetration of this new type of medicine. We need to tackle this issue urgently,” Mr. Perry insisted.

In conclusion, Mr. Perry issued a call to support a wider use of biosimilar medicines. “For the sake of Europe’s patients”, Mr. Perry said, “we need incentives on the demand-side, a consistent rational approach towards interchangeability and an increase of awareness and information aimed at reinforcing the confidence of patients and healthcare professionals in these high quality biopharmaceuticals”.

---

For further information contact Suzette Kox
E-mail: