Coherus Awaits August 2022 Date As FDA Accepts Ranibizumab Biosimilar
Company Set For Showdown With Samsung Bioepis For Biosimilar Lucentis
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.
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Xbrane Biopharma has taken a key step on its journey to begin generating cash from operations by early 2024 at the latest, after its Xlucane biosimilar ranibizumab asset was submitted to the European Medicines Agency by co-development and commercialization partner Stada.
User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.
Samsung Bioepis has celebrated the FDA’s first ever approval of an ophthalmic biosimilar with its endorsement of the firm’s Byooviz ranibizumab rival to Lucentis. The firm has also signaled a surprising expected launch date in the US, as well as offering expectations for launch in Europe where the biosimilar was also recently approved.