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.
Sandoz Puts Aflibercept In Its Sights With Phase III Data
Biosimilar Player Says It Will Offer ‘Differentiating Feature’ For Eylea Rival
Sandoz is looking to move ahead with its planned filings for one of the most significant off-patent biologic opportunities in the coming years – Eylea (aflibercept).

More from Products
Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
More from Generics Bulletin
Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.
Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.
Echoing wider sentiments in the biosimilar and generic drug industry, the IGBA has warned of the potential consequences of mercantilist tariffs on the global drug supply and their impact on industry and patients.