Tagged as: Mylan

Pipeline Updates from Clover, Pfizer, and Mylan/Biocon

Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone.  The facility, which is scheduled to open in the second half of 2018, will feature…

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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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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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Mylan and Biocon Gain Approval for Trastuzumab Biosimilar in Brazil

On December 29, Mylan and Biocon announced that their trastuzumab biosimilar, Zedora, was approved by Brazil’s National Sanitary Surveillance Agency. Zedora, a biosimilar of Genentech and Roche’s Herceptin, is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, and HER2-positive advanced gastric cancer. Zedora…

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