Susvimo, a PDS version of the blockbuster Lucentis, is a refillable eye implant that will extend Roche's commercial opportunity in wet-AMD but presents training challenges. Pricing is slightly below Lucentis.

Roche upended expectations for biosimilar Lucentis (ranibizumab) in the US, with a recent licensing deal signed with biosimilar sponsor Samsung Bioepis keeping the first proposed rival from the market until June 2022. The originator is also confident its pipeline assets will stem competition.

Samsung Bioepis recently broke new ground with the first US approval for a biosimilar with ophthalmic indications. But, senior vice-president and development division leader Kyung-Ah Kim tells Generics Bulletin, there remains work to be done to ensure that ophthalmic biosimilars can meet their full potential.

User fee goal dates are coming up in October for more than 15 applications, according to the Pink Sheet’s US FDA Performance Tracker.