Biotech Values

[DewDiligence]

EMA will issue additional FoB regs in next few months:

http://www.reuters.com/article/2012/01/06/us-medicines-biosimilars-idUSTRE8050ZQ20120106

Guido Rasi, the new executive director of the European Medicines Agency (EMA), told Reuters on Friday the London-based watchdog would issue its final guideline on biosimilar monoclonal antibodies in March or April.

Draft guidelines on the approval process for copies of other drugs will follow in May or June. These will include low molecular weight heparin, such as Sanofi's Lovenox or enoxaparin, and modern analogues of insulin.

However, NVS and MNTA have said that they no interest in a Lovenox FoB for the EU because the prevailing price is too low.