New collaborations to commercialize oncology biosimilars have been announced between Sandoz and Bio-Thera Solutions, and between Innovent Biologics and Ascentage Pharma.
Sandoz – Bio-Thera Solutions collaboration
On 8 September 2021, Sandoz announced its agreement with China-based Bio-Thera Solutions (Bio-Thera) to commercialize the latter’s bevacizumab oncology biosimilar, BAT1706.
Bio-Thera had submitted an application for its proposed bevacizumab biosimilar, BAT1706, to the European Medicines Agency on 25 November 2020 [1]; whilst the US Food and Drug Administration had accepted the Biologics License Application for its proposed bevacizumab biosimilar, BAT1706, in January 2021 [2].
Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor alpha (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian [3].
Bevacizumab is commonly used in combination with other treatments. The originator drug product is Genentech’s (now part of Roche) cancer medicine, Avastin, which had 2016 sales of CHF 6.8 billion (Euros 5.95 billion) before the advent of biosimilars.
Under the terms of the agreement, Bio-Thera Solutions, will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine following approval in the US, Europe, Canada and other selected countries. In addition, Bio-Thera Solutions will receive an upfront and milestone payments and is entitled to receive profit share payments.
The agreement sees Sandoz adding to its biosimilars and generics portfolio of over 50 products.
On 24 August 2020, Bio-Thera and BeiGene entered into a license, distribution and supply agreement for BAT1706 in China [4].
Innovent Biologics – Ascentage Pharma collaboration
In July 2021, Innovent and Ascentage announced a multifaceted strategic collaboration. This includes the joint commercialization of Ascentage’s China developed olverembatinib leukaemia biosimilar in China, together with the collaborative clinical development of an additional biosimilar (HALPRYZA®, a rituximab biosimilar injection) and a novel oncology medicine (lisaftoclax). Innovent also made an equity investment of US$30 million in Ascentage, and the latter will be eligible to receive up to US$115 if certain pre-specified milestones in development, registration and annual sales performance of the olverembatinib biosimilar are met. Profits from the commercialization agreement will be split equally.
Back in June 2020, China’s National Medical Products Administration approved Innovent’s copy biological IBI305, Byvasda [5] to be used in combination with its TYVYT (Sintilimab), positive phase III results were reported on 23 November 2020 [6].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/news/EMA-accepts-application-for-bevacizumab-biosimilar-BAT170
2. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for bevacizumab biosimilar BAT1706 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/news/FDA-accepts-application-for-bevacizumab-biosimilar-BAT1706
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-bevacizumab
4. GaBI Online - Generics and Biosimilars Initiative. Bio-Thera and BeiGene sign deal to license, distribute and supply Avastin copy biological BAT1706 in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/pharma-news/Bio-Thera-and-BeiGene-sign-deal-to-license-distribute-and-supply-Avastin-copy-biological-BAT1706-in-China
5. GaBI Online - Generics and Biosimilars Initiative. China approves bevacizumab copy biological Byvasda [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/news/China-approves-bevacizumab-copy-biological-Byvasda
6. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for sintilimab plus copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Oct 22]. Available from: www.gabionline.net/biosimilars/research/Positive-phase-III-results-for-sintilimab-plus-copy-biological-Byvasda
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