Tagged as: biosimilars

Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with…

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FDA Publishes Best Practices for Communication Between IND Sponsors and FDA During Drug Development

Last week FDA issued new guidance for industry and FDA review staff, entitled “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”  The guidance is intended to “describe best practices and procedures for timely, transparent, and effective communications between [IND] sponsors and FDA at critical junctures in…

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Momenta and Mylan Collaborating to Develop Biosimilar of Eylea® (aflibercept)

Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of this year.  According to the joint press release, the trial will be a randomized, double-blind, active-control, multi-center study in…

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