Biosimilars for aflibercept and ranibizumab in development

Formycon is solidifying its position in ophthalmologic follow-on products with the development of a biosimilar for aflibercept. It joins the follow-on version of ranibizumab that is already in Phase 3 clinical trials.

Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved by regulatory agencies in markets such as the EU and the United States, based on proven similarity with the originator biopharmaceutical reference product. While the global market for biosimilars are currently estimated at USD 2.5 billion, industry experts expect this figure to grow tenfold by the year 2020.

The biosimilars for aflibercept (FYB203) and ranibizumab (FYB201) are under joint development with Dutch-based Santo Holding GmbH. Bioeq GmbH, a subsidiary of Santo Holding GmbH, will be responsible for the clinical development, approval and  global marketing and licensing of both products.

“The development of biosimilars for Lucentis and Eylea has made us pioneers in the area of ophthalmology biosimilars with the two most important products in this field. We believe we are the only company with a Lucentis biosimilar already in the pivotal Phase III clinical study. Our strong position is also underlined by the number of formulation and application patents we have already filed which gives us a further competitive advantage,” said Dr. Carsten Brockmeyer, CEO of Formycon AG.

Formycon hopes to launch their biosimilars the day after the patent on the reference product expires, according to a company press release. Patents for aflibercept and ranibizumab are estimated to expire around 2020.