Bioeq will retain responsibility for filing of the Biologics License Application (BLA) with the U.S. Food and Drug Administration in Q4 2019 and for subsequent product supply. Coherus plans to launch the product in 2021.
Commenting on the agreement, Hannes Teissl, Board Member at Bioeq, said, "We are proud of having secured Coherus as our partner of choice for the U.S. This agreement is an important milestone in bringing a more affordable, highly effective treatment option for retinopathies, including age-related macular degeneration, to U.S. patients."
According to the terms of the agreement, Bioeq will receive upfront, regulatory and launch milestone payments as well as shared profits.
Commenting on future plans, Nicola Mikulcik, Board Member at Bioeq, said, "Starting in 2020, Bioeq will also be in a position to offer rights for its biosimilar ranibizumab to marketing and distribution partners outside the U.S."
Lucentis® is a registered trademark of Genentech, Inc. It is a biopharmaceutical product containing the monoclonal antibody ranibizumab, approved for eye conditions including neovascular ('wet') age-related macular degeneration, macular oedema following retinal vein occlusion, diabetic macular oedema, and diabetic retinopathy. In the U.S., annual sales of Lucentis® are around USD 1.8b.1
Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Biosimilars exhibit proven analytical and clinical similarity to their respective branded reference products.
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and the Strüngmann Group. Bioeq develops, licenses and commercializes biosimilars.
Coherus BioSciences is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus commercializes UDENYCA® (pegfilgrastim-cbqv) in the U.S. and has received regulatory approval for UDENYCA® in the European Union. For additional information, please visit www.coherus.com.
1. Reported US sales of CHF 1,798m equivalent to USD 1,816m (Fx 0,99). Roche, Quarterly Report Q3 2019. https://www.roche.com/investors.htm. Last accessed 4 November 2019.
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SOURCE Bioeq IP AG
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