OR WAIT null SECS
June 02, 2012
Extensive physicochemical characterization of the innovator product and the proposed biosimilar provides the foundation for demonstrating biosimilarity.
Does global development have to entail multiple comparability studies?
May 02, 2012
Poland's government aims to make the Eastern European country a biotech powerhouse.
April 05, 2012
On Mar. 29, 2012, the Generic Pharmaceutical Association reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.
March 02, 2012
Has the long-awaited guidance answered all of the industry's questions?
December 08, 2011
On Dec. 6, 2011, FDA announced that a public meeting will be held on Dec. 16, 2011 to discuss recommendations for a user fee program for biosimilar biological products for fiscal years 2013–2017.
November 02, 2011
Biosimilar manufacturers need better expression systems and analytical tools to compete.
August 11, 2011
Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.
March 31, 2011
The global market for biosimilars is set to grow from $243 million in 2010 to $3.7 billion in 2015, according to research from Datamonitor, an independent industry analyst company.