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Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term ‘strength’ in s 351(k) of the PHS Act for parenteral solutions to mean ‘total drug content’. The current interpretation does not allow a bio...

22 Nov 20 | Innovent released results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

24 Nov 20 | EU | The EMA approved Pfizer’s Nyvepria® (biosimil...

US District Court Judge Leonard Stark refuses to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

The Centre for Biosimilars reported on Alvotech’s global biosimilar strategy. Dr Joseph McClellan, Alvotech’s Chief Scientific Officer commented on Alvotech’s long-term expansion plans for global biosimilars markets, suggesting that Alvotech will obtain re...

Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.

Novartis released its annual report ‘Meet Novartis Management 2020’. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and na...

Alvotech and Alvotech & CCHT Biopharmaceutical announced they have partnered with Yangtze River Pharmaceutical Group to form an exclusive strategic partnership for the commercialisation of eight biosimilar medicines in China.  Alvotech and Alvotech & CCHT will be jo...

BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).