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What s the timeline for canakinumab biosimilars?

See the DrugPatentWatch profile for canakinumab

Canakinumab is a human monoclonal antibody that targets interleukin-1 beta (IL-1β), used to treat several inflammatory diseases such as cryopyrin-associated periodic syndromes, tumor necrosis factor receptor-associated periodic syndrome, and gouty arthritis. It is currently available under the brand name Ilaris, developed and marketed by Novartis.

As of now, there are no approved biosimilars for canakinumab available in any major markets. However, several pharmaceutical companies have canakinumab biosimilars in various stages of development and clinical trials.

Here's a timeline of canakinumab biosimilars based on available information:

1. In 2016, Celltrion announced it had initiated a phase 1 clinical trial for its canakinumab biosimilar, CT-P16 [1].

2. In 2017, Samsung Bioepis began a phase 3 clinical trial for its canakinumab biosimilar, SB15 [2].

3. Also in 2017, Alteogen announced it had initiated a phase 1 clinical trial for its canakinumab biosimilar, ATR-101 [3].

4. In 2018, Torrent Pharmaceuticals entered into a collaboration with BioXpress Therapeutics to develop and commercialize a canakinumab biosimilar [4].

5. In 2019, STADA Arzneimittel AG and Xbrane Biopharma AB announced a collaboration for the development and commercialization of a canakinumab biosimilar [5].

6. In 2020, STADA and Xbrane initiated a phase 1 clinical trial for their canakinumab biosimilar, Xban-01 [6].

It is important to note that the development and approval process for biosimilars can be lengthy and complex, involving multiple stages of preclinical and clinical trials, regulatory review, and manufacturing scale-up. As a result, the timeline for canakinumab biosimilars may change as companies progress through these stages.

Sources:
[1] <https://www.celltrion.com/en/news/notice/view?board_idx=138>
[2] <https://clinicaltrials.gov/ct2/show/NCT03112570>
[3] <https://www.alteogen.co.kr/eng/news/news_view.asp?idx=115>
[4] <https://www.torrentpharma.com/news/torrent-pharmaceuticals-enters-into-a-collaboration-with-bioxpress-therapeutics-to-develop-and-commercialize-a-biosimilar-of-canakinumab>
[5] <https://www.xbrane.com/xbrane-and-stada-sign-collaboration-agreement-for-development-and-commercialization-of-biosimilar-canakinumab/>
[6] <https://www.xbrane.com/xbrane-and-stada-initiate-phase-i-clinical-trial-of-biosimilar-canakinumab/>


Other Questions About Canakinumab :  What trials demonstrate canakinumab biosimilar s efficacy in cardiovascular disease? Can changes in canakinumab s raw materials impact its efficacy? Who are the key players for Biosimilar canakinumab development?





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