GaBI Generics and Biosimilars Initiative
News. EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi; FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli; FDA approves second strength of trastuzumab biosimilar Hercessi; EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz; more in Biosimilars/News
Biosimilars/News - GaBi Online
News. EC approval for three ustekinumab biosimilar: Eksunbi, Fymskina, Otulfi; FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli; FDA approves second strength of trastuzumab biosimilar Hercessi; EMA recommends approval of aflibercept biosimilars Afqlir and Opuviz; more in Biosimilars/News
EMA recommends approval of four bevacizumab biosimilars
Mar 12, 2021 · The CHMP recommended at its meetings held on 25–29 January 2021 and on 22–25 February 2021 that the four bevacizumab biosimilars receive a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and ...
Mabpharm gains approval for infliximab biobetter in China - GaBi …
Sep 10, 2021 · US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 20 July 2021 that its partner, China-based Mabpharm, had received marketing approval from China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), for its infliximab ‘biobetter’ (CMAB008).
EC approvals of four biosimilars: Tofidence, Wezenla, Avzivi and …
Oct 8, 2024 · On 22 August and 20 June 2024, the EC granted approval for two ustekinumab biosimilars: Celltrion’s SteQeyma and Amgen’s Wezenla, respectively. Both are biosimilars of Johnson & Johnson’s Stelara (ustekinumab).
FDA approves aflibercept biosimilars Enzeevu and Pavblu
Oct 15, 2024 · The FDA granted approval for Sandoz’s Enzeevu (aflibercept-abzv) and Amgen’s Pavblu (aflibercept-ayyh) on 12 and 23 August 2024, respectively, making them the fourth and fifth approvals for a biosimilar referencing Eylea. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [1], a recombinant fusion protein consisting of the ...
First denosumab biosimilars approved in Canada and the US
Apr 3, 2024 · 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. Sandoz announced that its denosumab biosimilar, Jubbonti and Wyost, received marketing authorization from Health Canada on 20 February and 4 ...
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Generics/News - GaBi Online
Generics/News | Posted 21/10/2022. On 7 September 2022, Dr Reddy’s Laboratories (Dr Reddy’s) announced the US launch of their generic lenalidomide capsules. And in July 2022, Lupin announced that its generic azilsartan medoxomil tablets had been approved by the US Food and Drug Administration (FDA).
FDA approves third aflibercept biosimilar Ahzantive - GaBi Online
On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea. The announcement of Ahzantive/FYB203 by Formycon and its licensing partner Klinge Pharma follows the news of approvals of Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis ...