Mabpharm Files for Infliximab Biosimilar in China; Sorrento to Seek US Biobetter Version

Sorrento Therapeutics said this week that its partner Mabpharm has filed a New Drug Application for its proposed infliximab biosimilar in China, and that it also plans a 2020 Biologics License Application (BLA) in the United States for a “biobetter” of infliximab.

Biobetters are an emerging class of follow-on biologics that could compete with biosimilars for market share. While the term “biosimilar” is applied to a drug that has been demonstrated to be highly similar to its reference, with no clinically meaningful differences from the originator product, the term “biobetter” refers to a therapy that has resulted from intentionally altering a biologic product in order to improve its clinical effects, require less frequent administration, or enhance tolerability.

Originator infliximab is sold as Remicade by Janssen.

Sorrento, through a global licensing agreement with Mabpharm, owns the global rights to Mabpharm’s infliximab biobetter antibody outside of China. Sorrento said it is planning to file all the required document for a BLA by the end of 2020.

In response to a query from The Center for Biosimilars^®, a Sorrento company spokeswoman said the biobetter’s route of administration will be by infusion, but “the biobetter is expected to have some clinical differentiation (safety/efficacy).”

Mabpharm recently submitted a New Drug Application with China’s National Medical Products Administration for a biobetter anti—tumor necrosis factor-alpha chimeric monoclonal antibody based on infliximab, using a system of Chinese hamster ovary cells; the company said that results in a “potentially better safety profile and lower immunogenicity.”

Thus far, the only biobetter option to be approved in any regulatory territory is Celltrion Healthcare’s Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis; it was approved by the European Commission last year.