Coherus Partners Formycon/Bioeq File Ranibizumab With FDA
Company ‘Excited For Potential Approval In 2022’ For Lucentis Biosimilar
Launch planning is underway for the Lucentis biosimilar that Coherus BioScienes has in-licensed in the US from Formycon and Bioeq, the US-based firm has revealed, as the eye-disease biologic was submitted to the US Food and Drug Administration.
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As 2021 draws to a close, Coherus BioSciences awaits word on its FDA filing for biosimilar Humira, while Pfizer plots a submission for a designation for interchangeability, aiming to emulate that enjoyed by Boehringer Ingelheim’s Cyltezo. Aurobindo will also plan for the exit of popular managing director Narayanan Govindarajan.
California-Based Coherus BioSciences delved further into its plans and expectations for its proposed proprietary pegfilgrastim on-body device, as it also detailed continued pricing challenges for the pre-filled syringe formulation.
The US FDA has accepted for review the CHS-201 Lucentis biosimilar product developed by Formycon/Bioeq that is to be sold in the US by Coherus BioSciences, shortly after approving the first ranibizumab biosimilar to treat wet age-related macular degeneration.