The Europe-based developer of a Lucentis biosimilar recently released interim Phase III results that it says demonstrate comparable outcomes between the two agents for vision improvements at eight weeks. The company says it is eying U.S. approval by 2020.
The news may give Formycon AG of Germany and its Swiss-based licensee, Bioeq IP AG, the advantage, at least for the moment, in the race to develop a biosimilar of Lucentis (ranibizumab, Roche/Genentech). Pfenex has put development of its Lucentis biosimilar candidate on hold. A South Korean company is also developing a Lucentis biosimilar. A biosimilar is a copy-cat of sorts of biological agents, the equivalent to generics of chemical-based agents.
The Formycon-Bioeq candidate, known as FYB201, is the subject of the COLUMBUS-AMD trial for treatment of neovascular age-related macular degeneration. The trial is evaluating patients over 48 weeks of treatment, and the last patients are expected to complete treatment by the end of June, Formycon said in a press release.
Formycon did not release any details of the latest interim findings, but said the confidence interval for improvement of best-corrected visual acuity lies within the predefined equivalence limits, and that the trial has not identified any safety or immunity issues.
Thiemo Schreiber, PhD, of Bioeq, which is conducting the Phase III trial, said the company aims to get approval in the United States in 2020 and in the European Union in 2022—the dates Lucentis comes off patent in the respective jurisdictions.
Pfenex, meanwhile, has shifted gears for its Lucentis biosimilar, PF582. Company Chief Financial Officer Susan Knudson was quoted in April by BioPharma-Reporter.com as saying the company would put the development program on hold. Pfenex has had a problem getting PF582 on track since former partner Pfizer pulled out in 2016. Officially, Pfenex says it is still seeking strategic partners for PF582.
Samsung Bioepis of South Korea also has a Lucentis biosimilar, SB11, in Phase III trials, but has not established a time line for the agent.
Lucentis isn’t the only anti-VEGF agent attracting biosimilar developers. Alteogen of South Korea says it plans to file an investigational new drug application with the Food and Drug Administration for ALT-L9, a biosimilar of Eylea (aflibercept, Regeneron).