Date: 2017-11-27
Type of
information: Initiation of development program
phase: 1
Announcement: update
Company: Formycon (Germany) Bioeq (Germany)
Product: FYB203 biosimilar version of Eylea® (aflibercept)
Action
mechanism:
- fusion protein/biosimilar/VEGF receptor. Aflibercept is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1. It binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Disease: neovascular age-related macular degeneration
Therapeutic
area: Ophtalmological diseases
Country:
Trial
details:
Latest
news:
- • On November 27, 2017, Formycon announced that the company is completing its final measures to establish a highly efficient biosimilar manufacturing process for FYB203, a biosimilar candidate for Eylea®** (aflibercept) which is used to treat neovascular, age-related macular degeneration (nAMD) and other serious eye conditions. Formycon has submitted various patent applications for the pharmaceutical formulation of this product, and therefore believes that FYB203 is also in a highly promising position for its market launch following the expiry of the reference product’s legal protection in the USA in 2023.
• On September 29, 2017, Formycon announced that the development of FYB203, a biosimilar project for Eylea® (aflibercept), which is also already being licensed out is progressing in accordance with the project schedule.
- • On February 29, 2016, Formycon has announced details on the second biosimilar product which is jointly developed with Santo Holding . FYB203 is a biosimilar candidate for Eylea® (aflibercept). In 2015, Eylea® achieved an estimated market volume of more than $ 4 billion. Formycon out-licensed FYB203 exclusively to Santo Holding GmbH in Holzkirchen in May 2015. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, the approval and the global marketing and licensing of FYB203. Both development programs will be developed in close coordination with the FDA, as well as the European Medicines Agency (EMA), and are striving towards approval in both regions.
Is
general: Yes
