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February 14, 2017
Aurobindo has added four cell-culture derived biosimilars to its product line.
January 27, 2017
The agency recommended approval of a total of eight drugs at its January 2017 meeting, two of which are biosimilars.
January 13, 2017
An FDA guidance on biosimilar naming garnered mixed responses from the Biosimilars Forum, the American College of Rheumatology, and Pfenex.
December 19, 2016
A pilot project, beginning in 2017, will support the development of biosimilars.
November 02, 2016
Reliable, high-quality products require innovative analytics and production.
The biosimilar pathway permits licensure based on less than full clinical data.
September 30, 2016
Ravi Limaye gives an overview of the biosimilar industry and projects for 2020.
September 26, 2016
The agency approves Amjevita (adalimumab-atto) for the treatment of inflammatory diseases.
September 12, 2016
Concerns have emerged that continued growth in the biosimilars market could be limited by mounting pressure to push down on prescription drug outlays.
August 15, 2016
The agency has adopted guidelines on the pharmacovigilance of biological drugs.