First Berlin Equity Research has published a research update on Formycon AG (ISIN: DE000A1EWVY8). Analyst Simon Scholes reiterated his BUY rating and maintained his EUR 50.00 price target.

Abstract
On 13 October Formycon announced the acceptance of its Keytruda biosimilar candidate, FYB206, for review by the FDA. Formycon submitted the biologics license application (BLA) for FYB206 to the FDA in Q3 of this year. FYB206 accounts for ca. half of our enterprise valuation of Formycon, and is the company’s main value driver in our view. We have no indication that any of Formycon’s competitors in the Keytruda biosimilar race have so far submitted a BLA. We think FDA acceptance of Formycon’s FYB206 BLA has two main implications. First, it triggers milestone payments from FYB206’s commercialisation partner for North America, Zydus. These payments underpin 2026 revenue guidance of €60m-€70m, which we believe implicitly incorporates FYB206 BLA acceptance-related milestones. Second, we expect it to mark the start of the patent dance–i.e. exchange of information and discussions with Keytruda’s developer/manufacturer (Merck) on the timing of the FYB206 launch. Ideally, these talks will secure FYB206 a position in the first launch group. Other leaders in the race to bring a Keytruda biosimilar to market include Celltrion, Samsung and Sandoz. Keytruda was the world’s best-selling drug in 2025 with sales of USD31.7bn. Formycon expects the earliest market entry of FYB206 after the expiry of market exclusivity of Keytruda in 2029 in the U.S. and after 2030 in the EU. Keytruda is subject to the buy-and-bill distribution and payment model in the U.S. This means that the process is controlled by individual doctors rather than the large pharmaceutical benefit managers who dominate the Stelara biosimilar market. We expect the U.S. Keytruda biosimilar market will be easier for Formycon to tackle than the U.S. Stelara biosimilar market. We maintain our Buy recommendation at an unchanged price of €50 (upside: 166%).