Blog
RSS FeedPosted by Michael Wonder on 27 Sep 2023
Japanese regulator OKs Celltrion's Humira biosimilar
26 September 2023 - Celltrion said it has received marketing approval from the Japanese Ministry of Health, Labor, and Welfare ...
Posted by Michael Wonder on 26 Sep 2023
Sandoz receives European Commission approval for Tyruko (natalizumab), first and only biosimilar for multiple sclerosis in Europe
26 September 2023 - Decision based on evidence from extensive analytical characterisation demonstrating similarity of biosimilar with reference biologic, in addition ...
Posted by Michael Wonder on 25 Sep 2023
FDA issues complete response letter for Udencya Onbody biologics license application solely due to an on-going review of inspection findings at a third-party filler
25 September 2023 - No issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or ...
Posted by Michael Wonder on 21 Sep 2023
Biocon Biologics receives European Commission approval for Yesafili, biosimilar aflibercept
20 September 2023 - Biocon Biologics, a subsidiary of Biocon, has announced that the European Commission granted marketing authorisation in ...
Posted by Michael Wonder on 21 Sep 2023
Alvotech provides US regulatory update on AVT02, a high concentration interchangeable biosimilar candidate to Humira (adalimumab)
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a ...
Posted by Michael Wonder on 20 Sep 2023
Tyenne, Fresenius Kabi’s tocilizumab biosimilar, receives European Commission approval
19 September 2023 - Tyenne is the first tocilizumab biosimilar approved by the European Commission. ...
Posted by Michael Wonder on 18 Sep 2023
Sandoz receives positive CHMP opinion for breast and gastric cancer biosimilar trastuzumab
18 September 2023 - Positive CHMP opinion based on comprehensive package of analytical, pre-clinical and clinical data. ...
Posted by Michael Wonder on 07 Sep 2023
Inflation Reduction Act may accelerate generic and biosimilar market entry, but questions remain around CMS guidance
5 September 2023 - Last week, the Centers for Medicare and Medicaid Services announced its selection of the first 10 prescription ...
Posted by Michael Wonder on 01 Sep 2023
Celltrion applies for Australian approval for Stelara biosimilar
31 August 2023 - Celltrion said it has completed a marketing authorisation application for CT-P43, a biosimilar referencing Stelara (ustekinumab) ...
Posted by Michael Wonder on 30 Aug 2023
Outlook Therapeutics provides regulatory update on FDA review of ONS-5010 / Lytenava (bevacizumab-vikg) for the treatment of wet AMD
30 August 2023 - FDA issues complete response letter for ONS-5010 biologics license application based on CMC and need for further ...
Posted by Michael Wonder on 24 Aug 2023
FDA approves first biosimilar to treat multiple sclerosis
24 August 2023 - The US FDA today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment ...
Posted by Michael Wonder on 24 Aug 2023
CVS Health launches company to produce cheaper ‘biosimilar’ versions of expensive biotech drug
24 August 2023 - CVS Health is launching a new company that will work directly with drug makers to produce ...
Posted by Michael Wonder on 25 Jul 2023
Launch of arthritis drug biosimilars ramps up US pressure on pricing 'middlemen'
25 July 2023 - Cheaper versions of one of the most costly and widely used arthritis treatments in the US ...
Posted by Michael Wonder on 24 Jul 2023
Biocon Biologics announces positive CHMP opinion for Yesafili, biosimilar aflibercept
24 July 2023 - Biocon Biologics today announced that the EMA’s CHMP has issued a positive opinion recommending approval of ...
Posted by Michael Wonder on 24 Jul 2023
Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar natalizumab
24 July 2023 - Positive CHMP opinion based on evidence from extensive analytical characterisation confirming similarity of biosimilar with reference biologic, ...