EGA Press Release

Friday, 27 May 2005

EGA CALLS FOR REASONED SCIENTIFIC APPROACH TO BIOGENERICS

The EGA has insisted today on the need to follow sound science when laying out the guidelines for “biogeneric” medicines in Europe. The EGA calls on EU medicines authorities to ensure the full participation of the biogeneric industry in all relevant debates.

The call came during EGA’s “3rd Annual Symposium on Biogenerics” before a crowd of some 130 delegates, including representatives of the European Commission and EU medicines regulatory bodies, meeting today and yesterday in London. Key presentations explored topics such as the current market conditions, the latest scientific advances, and the developing regulatory and legal framework for governing the development of biosimilar medicines in Europe.

A solid legal framework for biosimilar products will be firmly in place for the EU as of 20 November 2005 when the EU pharmaceutical legislation adopted last year enters into force, replacing the transitional framework currently in effect. As a result, focus has now shifted from the legal to the scientific debate. Draft concept papers and guidelines on quality issues have been published by the EMEA and are now open for consultation. Additional draft guidelines on clinical and pre-clinical requirements are expected soon. These documents will form the basis of scientific discussions and a workshop between industry and the EMEA at the end of 2005 to determine the future direction of the regulatory requirements for biosimilars.

The most crucial issue for biogenerics companies will be the extent of the pre-clinical and clinical tests and trials required to assure the safety and efficacy of a biosimilar product and to qualify for approval. The EGA fully supports EU legislation which calls for a ‘case by case’ assessment for the approval of biosimilars. This approach requires tests and trials in proportion to the complexity of each specific product. Others in the pharmaceutical industry are pushing for full clinical and pre-clinical trials in every case. While this approach would do little to further guarantee the safety of biogenerics, it would increase costs substantially, severely limiting competition and the delivery of lower-priced products to patients.

Greg Perry, EGA Director General, stated:

“It is absolutely vital that the EGA and other representatives of the biogenerics industry participate fully and actively in the forthcoming scientific discussions to ensure the balanced and well reasoned scientific approach to biogenerics contained in EU legislation is maintained at the regulatory level for the approval of biosimilar medicinal products.”

<< Back

---

For further information contact the EGA on
Tel: +32 (0)2 736 84 11 - .