European generics group calls for workable guidelines for biosimilar MAbs and consistent approach to biosimilars overall

In his opening address to the eighth European Generic Medicines Association (EGA) International Symposium on Biosimilar Medicines in London, UK, EGA director general Greg Perry praised the European for continuing to inspire the rest of the world regarding the development of scientific biosimilar (copies of genetically-engineered drugs) guidelines.

'If health care 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 health care professionals. He also emphasized 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.