Pearce IP BioBlast: w/e 01 May 2020

Significant biosimilar activities this week include:

  • 23 April 2020: Henlius Biotech announced it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.

  • 28 April 2020: Mylan and Biocon launched Fulphila® (pegfilgrastim) in Canada. Fulphila® is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

  • 29 April 2020: Gedeon Richter announced it has entered an asset purchase agreement with Mycenax Biotech for the purchase of a biosimilar tocilizumab product. Under the agreement, Richter will receive worldwide rights to develop, manufacture and commercialise the product which is expected to reach global markets in 2025.

  • 30 April 2020: Amgen filed suit against Hospira and Pfizer in the District Court of Delaware, alleging infringement of US patent 10,577,392, relating to the manufacture of Neupogen®. Interestingly, the patent was only granted on March 03, 2020, nearly 2 years after Hospira launched Nivestym®. 

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August 19, 2020

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