The European Generic Medicines Association (EGA) is pressing governments to draft a global agreement regarding the approval process for biosimilar medicines (“follow-on biologics”). Addressing the 8th EGA International Symposium on Biosimilar Medicines in London, EGA Director General Greg Perry advocated that now is the time to seek an international guideline.

Countries around the world, including Canada, U.S.A., Australia, Japan, Turkey and others already have a regulatory framework for biosimilar medicines. It is expected that the WHO will finalize their guidelines for evaluating similar biotherapeutic products (SBPs) this year. As a result, “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,” he said. It is essential to demonstrate the biosimilar matches the innovator product in terms of quality, safety and efficacy, and also to reassure patients and healthcare professionals. This will be addressed with a thorough comparability exercise with the reference product.

With the first major group of originator’s biosimilar products coming off of patent and/or data protection, it is expected the market for biosimilars to greatly increase in the coming years.

For more information, please see the following links:

http://www.egagenerics.com/pr-2010-09-02.htm

http://www.pharmatimes.com/Article/10-09-10/%e2%80%9cConsistent_global_approach%e2%80%9d_to_biosimilars_urged.aspx

http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf