OR WAIT null SECS
February 11, 2015
Pfenex announced that it entered into an agreement to partner with Hospira on the development and commercialization of PF582, a biosimilar candidate to Lucentis.
February 03, 2015
Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.
February 02, 2015
Ligand-binding assays are fundamental to characterizing biosimilars.
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Market forces may limit the success of CMOs.
January 08, 2015
An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.
December 19, 2014
FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.
December 01, 2014
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
November 20, 2014
FDA opens public docket on proposed criteria for “first generic” ANDAs.
Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.