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February 20, 2013
Merck and Samsung Bioepis have formed an agreement to develop and commercialize multiple prespecified and undisclosed biosimilar candidates.
November 02, 2012
Manufacturing and in-depth characterization provide basis for demonstrating product equivalence.
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on biosimilar monoclonal antibodies (mAbs).
October 30, 2012
AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.
October 01, 2012
The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.
August 01, 2012
An examination of the current and projected market for biosimilars, development costs for biosimilars compared with small-molecule generic drug, and partnerships in biosimilars.
June 07, 2012
Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.
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 10, 2012
Coherus BioSciences, Daiichi Sankyo Form Biosimilar Pact; Sandoz Agrees to Acquire Fougera Pharmaceuticals; and More.