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A new study indicates Intas Pharma’s romiplostim biosimilar Romy® has demonstrated a high overall response rate without adverse events in patients with immune thrombocytopenic purpura. Romy® has been approved in India.

Agilent awarded Prof. Anurag Rathore an Agilent Thought Leader Award for his contributions to the field of biopharmaceutical research and his work with advanced methods for molecular characterisation of biosimilars.

Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

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.