In October 2022, Alvotech announced new advances with partners Fuji Pharma in Japan and JAMP in Canada. In addition, in September 2022, with its partner STADA, Alvotech announced the launch of Hukyndra, its high-concentration, low-volume, citrate-free formulation, biosimilar to Humira (adalimumab), in Switzerland.
On 17 October 2022, Alvotech and Fuji Pharma announced that they have submitted an application to the Japanese Ministry of Health, Labor and Welfare for marketing approval of the first biosimilar candidate developed under the companies’ exclusive commercialization partnership. It has not been specified what the biosimilar candidate is. The Alvotech-Fuji Pharma partnership was originally formed in 2018 [1] and then extended in 2021 [2].
Following this, on 19 October 2022, Alvotech announced that it was extending its partnership with JAMP in Canada, adding two new biosimilar candidates to the partnerships portfolio: AVT16, a biosimilar for an immunology product and AVT33, a biosimilar for an oncology product. Originally, in 2020, Alvotech and JAMP entered into an agreement for an exclusive partnership to supply and commercialize five leading biosimilar candidates in the Canadian market [3].
The Alvotech-JAMP (or BIOJAMP) partnership enabled the launch of the adalimumab biosimilar (AVT02) in April 2022 in Canada. This was launched with the brand name Simlandi in Canada [4].
However, in the EU, Norway, Iceland, Lichtenstein, the UK and Switzerland, the product has the commercial names Hukyndra and Libmyris [5]. As noted above, in Switzerland the product is known as Hukyndra and this is the most recent country to announce the launch of the high-concentration, low-dosage, citrate-free version of adalimumab. In these regions, the product has been launched as part of a partnership with STADA which was announced in November 2019. This partnership hopes to bring AVT02 and six other biosimilar candidates across autoimmunity, oncology, and ophthalmology indications, to market in this region [6]. Alvotech is responsible for development and manufacturing, while STADA is responsible for the commercialization.
Alvotech also has strategic partnerships to bring AVT02 to market in many regions of the world and these include partnership with Teva in the US and Cipla Gulf in a selection of emerging markets [7, 8].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Alvotech makes deal with Fuji Pharma for biosimilars in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/Pharma-News/Alvotech-makes-deal-with-Fuji-Pharma-for-biosimilars-in-Japan
2. GaBI Online - Generics and Biosimilars Initiative. Partnerships formed and extended between Isu Abxis/Pharmasyntez and Alvotech/Fuji Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/pharma-news/Partnerships-formed-and-extended-between-Isu-Abxis-Pharmasyntez-and-Alvotech-Fuji-Pharma
3. GaBI Online - Generics and Biosimilars Initiative. New biosimilars partnerships from Alvotech and Biocon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/pharma-news/New-biosimilars-partnerships-from-Alvotech-and-Biocon
4. GaBI Online - Generics and Biosimilars Initiative. New adalimumab biosimilars prepare to launch in Canada, US and Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/biosimilars/news/new-adalimumab-biosimilars-prepare-to-launch-in-canada-us-and-europe
5. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars
6. GaBI Online - Generics and Biosimilars Initiative. Alvotech signs agreements with Stada and Yas Holding [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/pharma-news/Alvotech-signs-agreements-with-Stada-and-Yas-Holding
7. GaBI Online - Generics and Biosimilars Initiative. Teva changes course in Japan and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/pharma-news/Teva-changes-course-in-Japan-and-the-US
8. GaBI Online - Generics and Biosimilars Initiative. Alvotech and Cipla Gulf partnership announced [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Nov 18]. Available from: www.gabionline.net/Pharma-News/Alvotech-and-Cipla-Gulf-partnership-announced
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