Formycon AG's Keytruda Biosimilar Gains FDA Acceptance

First Berlin Equity Research has reaffirmed its BUY recommendation for Formycon AG, maintaining a target price of €50. The update comes following the FDA's acceptance of Formycon's Keytruda biosimilar candidate, FYB206, for review. This development is significant for Formycon, as FYB206 represents a major portion of their enterprise valuation and is a key value driver for the company.

The acceptance triggers milestone payments from North American commercialization partner Zydus, supporting revenue forecasts of €60m-€70m for 2026. Additionally, it initiates the 'patent dance' process with Merck, developers of Keytruda, potentially positioning FYB206 for an early market entry post-2029 in the U.S.

Formycon's FYB206 may enter the U.S. market more readily than competitors due to the 'Buy-and-Bill' model, managed by doctors rather than pharmaceutical managers. This contrasts with the more challenging Stelara biosimilar market.