BioBlast® w/e 29 July 2022: FDA approves Sandoz’s natalizumab, TGA approves Henlius/Cipla trastuzumab, Prestige/Intas bevacizumab deal, Biocon biosimilars revenue up

by , | Aug 1, 2022

Significant biosimilar activities this week include:

25 Jul 22 | US | FDA accepts ABLA for natalizumab biosimilar

Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease in adults – and Crohn´s Disease.  The EMA accepted a MAA for the same product earlier this month.

25 Jul 22 | AU | TGA approves Henlius/Cipla trastuzumab biosimilar

Henlius Biotech announced that the TGA has approved Henlius’ trastuzumab biosimilar, which will be marketed in Australia by Cipla.  The 150mg/vial product HANQUYOU has been sold as Zercepac™ in Europe and will be offered under trade names Tuzucip and Trastucip in Australia, covering all indications of the reference product.

26 Jul 22 | Prestige and Intas to commercialise bevacizumab biosimilar in US, EU & elsewhere

Prestige Biopharma announced an exclusive partnership with Intas and its affiliate Accord Healthcare to commercialise Prestige’s biosimilar bevacizumab in US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.  Prestige´s bevacizumab (HD204) is a biosimilar to Roche’s Avastin®.  US and EU regulatory filings are expected in 2023.

27 Jul 22 | Biocon biosimilars revenue up 29% in advance of close of Viatris deal

Biocon announced that its Q2 2022 revenue for biosimilars was up 29%.  This comes in advance of Biocon’s acquisition of Viatris’ biosimilars business, expected to close later in 2022.

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