Sandoz says it is optimistic of filing its proposed biosimilar to Regeneron/Bayer’s Eylea (aflibercept) in the US and the EU “in the coming months” after announcing confirmatory efficacy and safety data for its ophthalmology from the company’s ‘Mylight’ Phase III study.
Several rival biosimilar sponsors have already made progress with aflibercept biosimilar filings, including in the US Celltrion, Formycon/Coherus and Biocon/Momenta, as they look to seize one to the largest
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