Biosimilars/News
EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively.
First denosumab biosimilars approved in Canada and the US
The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.
Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars
In January 2023, Alvotech announced that it has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). In addition, Dr Reddy’s Laboratories Ltd announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI. This is now ready for filing in markets such as the US and Europe.
Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK.
EMA recommends approval of ustekinumab biosimilar Pyzchiva
On 22 February 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.
EC approval of ranibizumab biosimilar Rimmyrah
The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.
FDA BLA updates from Celltrion and Accord
In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector
On 26 December 2023, Coherus BioSciences announced the US Food and Drug Administration’s (FDA) approval of Udenyca OnBody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.
FDA approves bevacizumab biosimilar Avzivi
On 6 December 2023, the US Food and Drug Administration (FDA) approved China–based manufacturer Bio-Thera Solutions’ bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn). This product will be marketed globally by Sandoz.
FDA approves first tocilizumab biosimilar Tofidence
On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.
