Genentech Inc. filed a complaint against Centus in the United States (US) state of Texas on 15 November 2020. It is alleged that Centus’s Equidacent, a biosimilar to Genentech’s Avastin (bevacizumab), infringes 10 US patents.
The complaint has been filed as a Complaint for Patent Infringement and Declaratory Judgment and names corporations that are all foreign to the US. As such, Genentech deems that a court in any judicial district is suitable and has selected Texas as the product will be sold there.
The US Food and Drug Administration (FDA) accepted Centus’s Biologics License Application (BLA) on 18 November 2019. In their complaint, Genentech alleges that Centus did not provide required manufacturing information and that detailed ‘only conclusory assertions’ are made where detailed statements are required.
In addition, Centus provided a Notice of Commercial Marketing on 24 April 2020 indicating that their product would be marketed after 1 October 2020. However, Genentech has noted that on 9 November 2020, Centus refused to delay launch until litigations had been resolved.
When it comes to the 10 patent infringements, Genentech has noted that they are related to methods of making bevacizumab; cultivating Chinese hamster ovary (CHO) cells; making recombinant proteins; treating cancer with bevacizumab; making recombinant antibodies; treating a patient having glioblastoma with a vascular endothelial growth factor (VEGF) antagonist, methods of increasing the specific productivity of CHO cells that produce exogenous polypeptides, and filtrating viruses from compositions comprising recombinant proteins.
This is not the first time that Genentech has litigated over a bevacizumab biosimilar. In 2017, it made allegations against Amgen’s Mvasi, which were dismissed by FDA in 2019 [1]. Overall, in this current battle, Genentech seeks findings of infringement, a preliminary and permanent injunction, lost profits and attorneys’ fees.
Equidacent has also been approved in the European Union; and was granted marketing authorization on 29 September 2020 [2]. It is thought that here, it will be soon joined by another bevacizumab biosimilar, Aybintio, which is produced by Samsung Bioepis [3].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Genentech and Amgen settle biosimilar disputes [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Policies-Legislation/Genentech-and-Amgen-settle-biosimilar-disputes
2. GaBI Online - Generics and Biosimilars Initiative. EC approval for bevacizumab biosimilar Equidacent [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-bevacizumab-biosimilar-Equidacent
3. GaBI Online - Generics and Biosimilars Initiative. Phase III trial updates of Samsung Bioepis bevacizumab and aflibercept biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Dec 4]. Available from: www.gabionline.net/Biosimilars/Research/Phase-III-trial-updates-of-Samsung-Bioepis-bevacizumab-and-aflibercept-biosimilars
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