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October 06, 2011
EMA released two concept papers for consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines.
August 17, 2011
Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.
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.
August 02, 2011
Are biosimilars the next big thing or just the next big bubble?
July 02, 2011
Follow-on versions of complex biologics require extensive expertise in development and regulatory procedures.
June 16, 2011
Merck and Hanwha Chemical have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel, a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.
June 02, 2011
FDA weighs multiple views regarding the Biologics Price Competition and Innovation Act.
May 12, 2011
FDA is asking for input on the development of a user-fee program for biosimilar and interchangeable biological product applications.
May 02, 2011
Innovator and generic-drug companies need to adapt to compete in the biosimilars market.
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.