New EMEA biosimilar drug doc welcomed

The European Association for Bioindustries (EuropaBIO) has welcomed the European Medicines Agency's (EMEA) new guidance on biosimilar drugs, titled: Questions and Answers on biosimilar medicines. The group, which represents about 1,800 small and medium-sized firms engaged in biotechnology R&D, testing, manufacturing and distribution, especially supported the European regulator's definition of biosimilar products as distinct from generics.

The EMEA document states that, "since biosimilar and biological reference medicines are similar but not identical, the decision to treat a patient with a reference or biosimilar medicine should be taken following the opinion of a qualified health care professional." This would appear to limit any government or insurance policy of automatic substitution in the pharmacy of a branded for a follow-on biotechnology product.

Andrea Rappagliosi, the chairman of the EuropaBio's health care council, said: "this document provides some clarification on the use of biosimilars and underscores the importance of the biosimilar regulatory pathway established in 2004." He added: "the EMEA should be acknowledged for its leadership in drawing attention to the uniqueness of biosimilars and the need for a separate approach for the use of this new class of products to that of generics."