After an extraordinary year that saw demand patterns and the supply chain upended by the COVID-19 pandemic, as well as a major merger that has transformed one of the global off-patent industry’s biggest players, Generics Bulletin’s Top 50 has once again seen significant changes.

Samsung Bioepis has confirmed completion of its Phase III trial for a proposed biosimilar to Soliris, putting it ahead of rival developer Amgen which has negotiated a date-certain US launch.

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.