News Feature | March 13, 2014

Formycon AG Reports Outlicensing Of First Biosimilars Project

By Estel Grace Masangkay

Biosimilars developer Formycon AG reported that it has ended the year 2013 with out licensing of its first biosimilars development project.

The company also appointed experienced pharma managers to its board of directors and advisory board to maximize its momentum as a global biosimilar developer.

Biosimilars are cost-effective follow-on products of complex, biotechnologically developed medicines and drugs. Around 12% to 15% of biotechnologically manufactured medicinal products are winning approval every year with total volume to hit over $15 billion in the year 2020, said Formycon.

Formycon plans to concentrate on third wave biosimilars for highly regulated markets such as those in Europe, U.S., and Japan. Dr. Nicolas Combé, Director and CFO of Formycon AG, said "We are concentrating specifically on the so-called third wave of biosimilars, i.e. products whose patents expire as of the year 2020.”

With active partners secured for its first project, the company said it plans to further license out and extend its pipeline. As of present, Formycon has two projects in development, one of which it licensed to Santo Holding GmbH last December 2013. “We also reached the milestones for the second development project: after conclusion of the analysis phase, we started with the development of the cell line, so that the second Formycon project is also going according to schedule. The licence options for the second Biosimilar of Formycon’s pipeline are already to be examined in the second half of the year 2014,” the company stated in its press release.

A total of twenty bisimilars have won marketing approval in the EU to date.  Other biosimilars are already in the market in other parts of the world such as Switzerland, Australia, Japan, Korea and Malaysia among others. the U.S. Food and Drug Administration (FDA) is currently formulating new guidelines for the marketing authorization of biosimilars (FDA Draft Guidances on Biosimilars).