Creating a sustainable biosimilar product pipeline
Formycon has the capabilities and resources to drive the development of biosimilar drug candidates all the way from early originator product analysis through to pivotal clinical trials and regulatory approval in the high regulated markets.
With FYB201, FYB202, FYB203 and FYB205 the company currently has four biosimilar products in pre-clinical and clinical testing phases. Each of the biosimilars will target a multi billion dollar originator market. Two of these biosimilar candidates have already been out-licensed. License partner for FYB201 is Bioeq IP AG, a joint venture of Santo Holding AG and Polpharma Group. License partner for FYB203 is Santo Holding (Deutschland) GmbH. For FYB202 Formycon has formed a joint venture with Aristo Pharma GmbH, a company of the Struengmann Group.
Most advanced of Formycon’s biosimilar pipeline is FYB201, a biosimilar version of the blockbuster ophthalmology drug ranibizumab (Lucentis®)*. In partnership with Bioeq IP AG Formycon has commenced a global pivotal Phase III clinical trial of FYB201. The objective of this study is to demonstrate biosimilarity of FYB201 to Lucentis®, in terms of safety, efficacy and immunogenicity, in patients with neovascular age-related macular degeneration (nAMD). The study was developed in consultation with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which should facilitate regulatory approval in these two key markets. In May 2018 Formycon and Bioeq announced that FYB201 showed comparable efficacy to the reference product in the phase III study.
Ranibizumab inhibits vascular endothelial growth factor (VEGF) which is responsible for excessive formation of blood vessels in the retina leading to progressive loss of vision.
Market launch of the FYB201 biosimilar is anticipated upon expiry of the Lucentis® patent in the U.S. in 2020 and in Europa in 2022.
FYB203 is a biosimilar for Eylea®** (aflibercept). As Lucentis® Eylea® is used for the treatment of neovascular age-related macular degeneration (neovascular AMD) and other serious eye conditions. Besides to the vascular endothelial growth factor VEGF-A aflibercept also binds to placental growth factor PlGF. Thus aflibercept suppresses the formation of blood vessels in the retina, which would impair the vision.
With FYB201 and FYB203 our development pipeline covers the two most important and best-selling medications in the field of ophthalmology.
FYB202 is a Biosimilar Candidate for Stelara®*** (ustekinumab), a human monoclonal antibody. Since 2009, the drug has been used to treat various severe inflammatory conditions such as moderate to severe psoriasis. In 2016, its indications were extended, allowing Stelara to also be used for the treatment of Crohn’s disease. Ustekinumab addresses major patient potential and offers significant opportunities for growth.
Formycon will steadily update the information on its product development pipeline, and add further biosimilar product development candidates in the future.
* Lucentis is a registered trademark of Genentech Inc.
** Eylea is a registered trademark of Regeneron Pharmaceuticals Inc.
*** Stelara is registered trademark of Johnson & Johnson