FDA Uses Biosimilar Strategy For Complex Generics, Offers Pre-ANDA Meetings
Executive Summary
Meetings must have specific topics, and may not always be granted, but are available to sponsors to gain advice on moving forward with complex products.
You may also be interested in...
Pre-ANDA Meeting Goals May Be Created In GDUFA II
Idea could help sponsors of complex generics, but will it extend to other ANDAs?
Advair Generics Likely Lucrative Product For Few That Can Clear High Bar
With release of draft bioequivalence guidance for GSK’s blockbuster asthma and COPD treatment, generics seem more likely than ever, but there may be only a select number of companies who can meet the guidance’s requirements.
Teva’s Final Copaxone Firewall Is Complexity Of ANDA Review After Court Tosses Patent
Federal Circuit finds claims covering Copaxone’s latest expiring patent are invalid; Mylan says it plans to launch its generic of the MS drug in May 2014.