The European Medecines Agency (EMEA) has issued draft guidelines on the development of "similar biological medicinal products", the so-called biosimilar medecines.
The draft guideline follows two existing EMEA documents adopted in 2003 and aims at describing the EMEA approach to the development and approval of these products.
The final guidelines will define what is a biosimilar medicine and will be a "user guide" for applicants that claim biosimilarity of their products.
The aim of this guidelines follows the line of recent declarations by Thomas Lonngren, director general of the EMEA, who supports more detailed studies on potential health risks as a condition for new drug approvals.
Any comments to the draft guideline should be sent to the EMEA Comparability Working Party Secretariat - Fax: +44 20 74 18 86 13 E-mail: susana.soobhujhun@emea.eu.int by end of February 2005.
What are biosimilar products?
The draft guidelines explain that a company may choose to develop a new biological medicinal product claimed to be "similar" to an orginal reference medicinal product which has been granted a marketing authorisation in the EU.
The guidelines also say that in this case, comparability studies are needed.
Biosimilar medicines might also include vaccines and allergens.
EuropaBio, the European Association of Bioindustries (which includes multinationals such as BASF, GlaxoSmithKline, Monsanto, Novartis, Procter & Gamble...) defines biosimilar products as second versions of biologic medicines that depend on the same mechanism of action and are intended to be used for the same therapeutic indication as the innovator’ product.
They specify that biosimilar products are not chemical generics, and claim that a small change in the manufacturing process can indeed have an important impact on the efficacy and safety of a product.
