Clover Biopharmaceuticals will adopt GE Healthcare’s centrally automated FlexFactory platform at its facility in Zhejiang, China where it plans to make a biosimilar to Amgen’s Enbrel.
The US FDA has approved its sixth biosimilar and second version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab): Cyltezo, made by Boehringer-Ingelheim.
Imraldi becomes the second version of AbbVie’s best-selling biologic Humira (adalimumab) to be approved and the fourth biosimilar success for Samsung Bioepis in Europe.
The EMA has recommended the approval of Samsung Bioepis’ adalimumab biosimilar, placing the firm on the brink of having three anti-TNF inhibitors in Europe.
Samsung Bioepis’ Renflexis has become the second biosimilar of rheumatoid arthritis biologic Remicade (infliximab) to be recommended for approval in the US.
US patients and physicians favour domestically-made biosimilars according to Coherus Biosciences. But if quality is assured should the manufacturing location matter?
Biosimilar developers have welcomed a court ruling against AbbVie regarding Humira indication patents, but an IP lawyer warns the judgement is not binding outside the UK.