Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2024
US FDA approves Celltrion's Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab)
17 December 2024 - Steqeyma is expected to be marketed in the US in February 2025. ...
Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 07 Dec 2024
US FDA approves Biocon Biologics' Yesintek biosimilar to J&J's Stelara (ustekinumab)
2 December 2024 - Biocon Biologics announced today that the US FDA has approved Yesintek (ustekinumab-kfce), a biosimilar to the ...
Posted by Michael Wonder on 02 Nov 2024
Alvotech and Teva announce US FDA approval of additional presentation of Selarsdi (ustekinumab-aekn), expanding its label to include further indications approved for reference product, Stelara (ustekinumab)
22 October 2024 - Approval of Selarsdi 130 mg/26 mL in a single dose vial for intravenous infusion expands label to ...
Posted by Michael Wonder on 17 Oct 2024
The science of biosimilars - updating interchangeability
18 October 2024 - Almost 15 years ago the US FDA was given the authority to approve biosimilars through the ...
Posted by Michael Wonder on 13 Oct 2024
US FDA approves Dong-A ST’s Imuldosa (ustekinumab-srlf), a biosimilar to Stelara
11 October 2024 - Dong-A ST announced on October 11 2024 that Imuldosa (ustekinumab-srlf/DMB-3115), a biosimilar referencing Stelara, has won ...
Posted by Michael Wonder on 09 Oct 2024
Teva Prolia (denosumab) biosimilar candidate is accepted for review by US FDA and EU EMA
8 October 2024 - TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of ...
Posted by Michael Wonder on 30 Sep 2024
Fresenius Kabi and Formycon receive US FDA approval for biosimilar Otulfi (ustekinumab-aauz)
30 September 2024 - In accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has ...
Posted by Michael Wonder on 12 Aug 2024
Sandoz receives FDA approval for Enzeevu (aflibercept-abzv), further strengthening US biosimilar position
12 August 2024 - Enzeevu (aflibercept-abzv) approved to treat neovascular age-related macular degeneration. ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 23 Jul 2024
FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab)
22 July 2024 - Epysqli is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. ...
Posted by Michael Wonder on 22 Jul 2024
Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for adalimumab-adbm injection, Boehringer’s biosimilar to Humira
18 July 2024 - First biosimilar with an exclusive low cash price on the GoodRx platform. ...
Posted by Michael Wonder on 01 Jul 2024
FDA grants approval for Eylea biosimilar FYB203/Azhantive (aflibercept-mrbb)
28 June 2024 - Formycon and its licensing partner Klinge Biopharma announce that the US FDA today approved FYB203/Azhantive (aflibercept-mrbb), ...
Posted by Michael Wonder on 01 Jul 2024
FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialised by Sandoz in US
1 July 2024 - FDA granted provisional determination for interchangeability designation for Pyzchiva. ...
Posted by Michael Wonder on 29 May 2024
FDA approves first interchangeable biosimilar for two rare diseases
28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to ...