Biosimilars/News
EMA recommends approval of first natalizumab biosimilar Tyruko for MS
On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Tyruko (natalizumab), a biosimilar of reference product Tysabri, intended for the treatment of multiple sclerosis (MS).
China approves bevacizumab copy biological Ankeda
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 9 December 2019 that it had approved Ankeda, a bevacizumab copy biological.
EMA recommends approval of first aflibercept and tocilizumab biosimilars
On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Yesafili (aflibercept), an ophthalmology biosimilar, and Tyenne (tocilizumab), an immunosuppressant used largely for treatment of arthritis.
Coherus: lowest price adalimumab biosimilars announced
Coherus BioSciences has announced that it will launch Yusimry, its adalimumab biosimilar, at the lowest price announced to date in the US.
Celltrion: advances for Yuflyma and Vegzelma biosimilars
In the first half of 2023, South-Korea based Celltrion Biologics announced the approval of their Yuflyma (adalimumab-aaty) biosimilar in the US, the winning of a bid to supply Italy and Belgium with bevacizumab biosimilar Vegzelma.
Alkem launches first cetuximab similar biologic in India
In May 2023, Alkem Oncology announced the launch of Cetuxa, the fist similar biologic of cetuximab used in the treatment of head and neck cancer. The cetuximab originator was developed by Merck and is sold under the brand name Erbitux.
EMA recommends approval of eculizumab biosimilar Epysqli
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 March 2023 that it had adopted a positive opinion for Epysqli.
Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US
The STADA and Xbrane co-developed Ximluci, ranibizumab biosimilar is to launch in Europe and will now also be available on the UK’s National Health Service (NHS). In addition, the partners have submitted their Biologics License Application (BLA) to the US Food and Drug Administration (FDA).
US and EC approvals for Hyrimoz, US approval for Udenyca autoinjector
In March 2023, the US Food and Drug Administration (FDA) approved Sandoz’s Hyrimoz biosimilar, a citrate-free high-concentration formulation (HCF) of adalimumab, as well as Coherus Biosciences’ (Coherus) innovative single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv).
Biosimilar launches in Canada and US: Byooviz and Stimufend
In Canada, Biogen announced that their Byooviz (ranibizumab) injection, a biosimilar of Lucentis, is available as of March 2023. In the preceding month, Fresenius Kabi launched Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, in the US.
