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February 28, 2020
Article
This is the third Form 483 Biocon has received for the insulin plant in 3 years.
February 24, 2020
Article
Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.
February 21, 2020
Article
With Trazimera in place, Herceptin now has 3 biosimilar competitiors.
July 27, 2018
Article
Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.