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RSS FeedPosted by Michael Wonder on 31 Jan 2023
A watershed year for biosimilars — if regulators and policy makers step up
31 January 2023 - 31 January is set to mark the start of a watershed year for the biosimilars industry ...
Posted by Michael Wonder on 31 Jan 2023
Amjevita (adalimumab-atto), first biosimilar to Humira, now available in the United States
31 January 2023 - Four years of real world experience in more than 300,000 patients and over 60 countries. ...
Posted by Michael Wonder on 30 Jan 2023
Sandoz receives positive CHMP opinion for citrate free high concentration formulation of adalimumab biosimilar
30 January 2023 - Sandoz is seeking approval of high concentration formulation adalimumab for use in all indications of reference medicine. ...
Posted by Michael Wonder on 26 Jan 2023
A “method of use” to prevent generic and biosimilar market entry
25 January 2023 - A critical pathway that generics and biosimilars manufacturers have used to circumvent patent thickets has been “skinny ...
Posted by Michael Wonder on 17 Jan 2023
Stada and Xbrane receive approval for Ximluci
17 January 2023 - Stada and Xbrane have announced that the UK’s MHRA has provided a marketing authorisation for Ximluci. ...
Posted by Michael Wonder on 17 Jan 2023
Celltrion gets nod from Canadian regulator for sales of Avastin biosimilar
17 January 2023 - Celltrion obtained permission from Health Canada to sell Avastin (bevacizumab) biosimilar Vegzelma (CT-P16) on Tuesday. ...
Posted by Michael Wonder on 17 Jan 2023
China NMPA approves Bio-Thera Solutions’ BAT1806, a biosimilar to Actemra (tocilizumab)
16 January 2023 - World’s first approved biosimilar to Actemra. ...
Posted by Michael Wonder on 04 Jan 2023
Samsung Bioepis announces Health Canada approval of citrate free high concentration of Humira biosimilar (adalimumab; SB5)
3 January 2023 - With the approval, Samsung Bioepis has both low (40 mg/0.8 mL) and high (40 mg/0.4 mL) concentration ...
Posted by Michael Wonder on 24 Dec 2022
Celltrion USA announces submission of the biologics license application of novel subcutaneous formulation of CT-P13 to US FDA
22 December 2022 - CT-P13 SC is a novel subcutaneous formulation of infliximab. ...
Posted by Michael Wonder on 22 Dec 2022
Update on US regulatory status of AVT02, Alvotech’s proposed high concentration, interchangeable biosimilar to Humira
22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for ...
Posted by Michael Wonder on 21 Dec 2022
Ontario expanding safe use of biosimilars
20 December 2022 - Transitioning to biosimilars will allow province to invest in and improve access to medicines. ...
Posted by Michael Wonder on 15 Dec 2022
Fresenius Kabi receives US FDA approval for biosimilar Idacio (adalimumab)
14 February 2022 - Idacio is a citrate free formulation of adalimumab. ...
Posted by Michael Wonder on 10 Dec 2022
FDA accepts Biogen biologics license application for BIIB800, a biosimilar candidate referencing Actemra (tocilizumab)
9 December 2022 - Biogen announced that the US FDA has accepted for review the abbreviated biologics license application for ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 23 Nov 2022
Rezvoglar becomes second interchangeable insulin biosimilar
23 November 2022 - The FDA has granted Eli Lilly’s long-acting insulin glargine biosimilar, Rezvoglar, an interchangeability designation, making it ...