In late 2022 and early 2023, Alvotech announced several strategic partnership advances to further their global reach as a biotech company specializing in the development and manufacture of biosimilar medicines.
Specifically, these advances cover their partnership with Fuji Pharma Co in Japan, STADA in Europe and Bioventure, a Dubai-based pharmaceutical company, Minapharm Pharmaceuticals, a Cairo-based pharmaceutical company, and MiGenTra GmbH, a Germany-based company in Africa and the Middle East. In all cases, products are developed and manufactured by Alvotech and marketed and commercialized by their partners.
Alvotech-Fuji Pharma partnership
Together with partner Fuji Pharma Co, Alvotech is expanding their existing exclusive commercialization partnership that covers Japan, by adding a new undisclosed biosimilar candidate. The Alvotech-Fuji Pharma partnership was formed in 2018 [1] and then extended in 2020 [2] and 2022. The partnership now covers seven biosimilars including the new candidate. In October 2022, Alvotech-Fuji Pharma announced the submission of an application to the Japanese Ministry of Health, Labour and Welfare for marketing approval of the first biosimilar candidate developed under the companies’ partnership [3].
Alvotech-STADA partnership
In Europe, Alvotech and STADA are increasing the availability of high-quality biological treatments by rolling out their Hukyndra (adalimumab) high-concentration, low-volume, citrate-free formulation of adalimumab in several European countries: Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania and Slovenia. This follows initial introduction of Hukyndra in nine other European countries: Austria, Estonia, Finland, France, Germany, Lithuania, Slovakia, Sweden and Switzerland.
Hukyndra is also known as Libmyris [4] and the developmental name, AVT02.
Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis. The originator is AbbVie’s Humira [5].
Hukyndra is the first product launched through the exclusive Alvotech-STADA partnership first announced in November 2019 [3] covering biosimilar candidates across immunology, oncology and ophthalmology indications.
Alvotech-Bioventure-Minapharm-MiGenTra partnership
Alvotech has also signed an exclusive license agreement with Bioventure, Minapharm Pharmaceuticals and MiGenTra GmbH for the commercialization of multiple biosimilar candidates in Egypt and 18 additional countries in Africa and the Middle East. The partnership will now see the latter companies share the launching and marketing responsibilities of Alvotech manufactured biosimilars in these regions. All other terms and product details in the agreement currently remain confidential.
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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 2023 Jan 27]. 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 2023 Jan 27]. 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. Advances for Alvotech’s partnerships in Japan, Canada and Switzerland [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/advances-for-alvotech-s-partnerships-in-japan-canada-and-switzerland
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Jan 27]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
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