Pearce IP BioBlast: w/e 17 Apr 2020

Significant biosimilar activities this week include:

  • On 14 April 2020, Mylan and Biocon launched Fulphila® (pegfilgrastim) in Australia. Fulphila® is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections.

  • On 15 April 2020, Merck and Samsung Bioepis launched Ontruzant® (trastuzumab) in the US.  Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline based therapy.

  • On 16 April 2020, Biocon announced it had received an Establishment Inspection Report (EIR) from the FDA for two biologics facilities in Bengaluru.  Biocon expects that this EIR will allow for the filing of marketing authorisation applications for biosimilar products in several global markets.

  • On 16 April 2020, the Centre for Biosimilars published America's Health Insurance Plans call for further action to address barriers to competition for biosimilars.  This action includes shortening product exclusivity periods, creating a searchable Purple Book, introducing more and better education about biosimilars and eliminating product hopping.

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Biosimilars Bulletin 

November 9, 2020

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