Last Friday, Pfizer handed the rights back to its partner Pfenex for PF582, a biosimilar version of Roche/Genentech’s ‘wet’ age-related macular degeneration (AMD) drug Lucentis (ranibizumab) currently in Phase I/II clinical trials.
Pfenex has been left evaluating its options, but for Formycon - which has its own version of Lucentis (FYB201) in development - the news drove a 16% rise in its share price and according to CEO Dr. Carsten Brockmeyer could strengthen the firm’s position in a market worth over $3bn annually.
“To our knowledge we, together with our license partner Santo Holding, are currently the only company in the world with a biosimilar candidate for Lucentis in clinical phase III,” he told Biopharma-Reporter.com.
“In contrast to full antibodies, which are produced by mammalian cell culture, a technology which many companies have, ranibizumab - the active component of Lucentis - is an antibody fragment,” he continued.
“[This is] produced in E. coli, a technology very few companies have access to. Formycon started early with the development of a ranibizumab biosimilar, at a time when most other companies were focusing on the so called first and second wave of biosimilars. So many companies have missed this opportunity.”
Besides Pfenex, Coherus BioSciences has a ranibizumab biosimilar in its pipeline, while Intas Biopharmaceuticals launched a ‘similar biologic’ to Lucentis in India last year. However, Brockmeyer said it remains unclear if the company will pursue a strategy which allows for approval in more highly regulated regions.
Eitherway, Formicon expects to be first to market when Lucentis loses its exclusivity across various markets from 2020 onwards.
“We are optimistic that our biosimilar will receive approval in due time enabling a commercialisation on day one after patent expiry of the reference product.”
Third-wave biosimilars
Along with FYB201, Formycon is developing a copycat version of Regeneron’s Eylea (aflibercept), and describes both as ‘third-wave’ biosimilars.
First wave products are generally versions of cytokines, growth factors and hormones already off patent - such as filgrastim and epoetin alfa. Second wave biosimilars are generally monoclonal antibodies which come off patent before 2020, for example Pfizer/Celltrion’s recently US approved infliximab.
Third wave biosimilars are biologics coming off patent after 2020 which are generally more complex mAbs or antibody fragments, and need – Brockmeyer told delegates at BPI Europe earlier this year – a full understanding of the mode-of-action of the molecule in order to develop.