Formycon and its licensee Bioeq today announced positive interim results for a phase 3 clinical trial of FYB201, a proposed ranibizumab biosimilar referencing Lucentis, which is an anti–vascular endothelial growth factor therapy approved to treat patients with neovascular age-related macular degeneration.
Formycon and its licensee Bioeq today announced positive interim results for a phase 3 clinical trial of FYB201, a proposed ranibizumab biosimilar referencing Lucentis, which is an anti-vascular endothelial growth factor therapy approved to treat patients with neovascular age-related macular degeneration (nAMD).
According to Formycon, the COLUMBUS-AMD trial, which compared the efficacy of FYB201 of the reference ranibizumab in patients with nAMD, reached its primary efficacy endpoint, measuring the change in best corrected visual acuity after 8 weeks. The confidence interval, says the drug maker, lies within the pre-specified equivalence margin, and the study has not raised any new concerns about safety or immunogenicity.
The final patient in the trial, in which patients are treated for a total of 48 weeks, is expected to complete treatment in the second quarter of 2018. Data from the study will be included in applications for marketing approval in both the United States and Europe.
Thiemo Schreiber, PhD, of Bioeq, said in a statement, “Our aim is the approval and launch of FYB201 as the first biosimilar to Lucentis in the [United States] in 2020 and in the countries of the European Economic Area in 2022. We thus want to offer a larger number of patients more affordable access to this important and highly effective treatment.”
Other companies developing ranibizumab biosimilars include Samsung Bioepis, which began a phase 3 trial of its proposed product, SB11, in 2017. Samsung Bioepis projects that it will have collected its primary outcome data by April of 2019. Additionally, Pfenex, which reassumed rights to PF582 from Pfizer in 2016, has indicated that it may be considering resuming work on its biosimilar candidate after having halted development due to costs and a long development timeline. In April 2018, Pfenex indicated that it was interested in working with a strategic development partner to advance its program.