Formycon Sees Opportunity Amid Patent Cliff

Formycon, a German biotech company, is taking advantage of patent expirations at Novartis and Merck to expand its business. The company's flagship project, FYB206, targets the market for Merck's Keytruda, which will reach peak sales of $33 to $34 billion by 2028 but faces a patent cliff with key US substance patents set to expire in late 2028.

The ophthalmology segment is another area where Formycon is performing well. Its Lucentis biosimilar captured over 80% market share in the UK, while Novartis's global Lucentis sales fell by 29% in 2024 due to cheaper alternatives entering the market.

To demonstrate pharmacokinetic equivalence with Keytruda, Formycon completed a Phase III trial called Dahlia in melanoma patients. The study showed that FYB206 is absorbed and metabolized similarly to Keytruda, allowing the company to skip lengthy efficacy studies and expedite its approval process.