Europe's advisory body CHMP updates on pandemic medicines, backs Hospira's biosimilar filgrastim and several generics and clears added use for Tar

Following three days of meetings last week, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) reviewed further results from clinical studies and post-marketing experience for all three centrally-authorized pandemic influenza vaccines, gave a positive opinion on Hospira's filgrastim and gave a positive opinion on Tarceva (erlotinib) in non-small cell lung cancer.

Regarding the flu vaccines, the CHMP said that the data confirm the expected immunogenicity and safety profile for the vaccines for Baxter International's Celvapan, Novartis' Focetria and GlaxoSmithKline's Pandemrix. For Celvapan, the Committee recommended changes to the product information to include additional information on the vaccine's immunogenicity and safety. The latest data on the safety of Celvapan show no unexpected serious safety issue. The most frequent adverse reactions that have been reported are non-serious and as expected.

The Committee adopted a positive opinion recommending the granting of a marketing authorization for Nivestim (filgrastim), from Hospira, intended for the treatment of neutropenia. This medicine has shown to be similar to the reference medicinal product Amgen's Neupogen - which, with follow on drug Neulast (pegfilgrastim) generated sales of $4.64 billion for the US biotechnology firm last year, already authorized in the European Union, in the indication applied for. Novartis' generics unit Sandoz gained similar clearance for its biosimilar filgrastim in February this year and Ratiopharm (just acquired by Teva) in March 2008 (The Pharma Letters passim).