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®.