Formycon AG (FYB.DE) on Wednesday said its pivotal Dahlia pharmacokinetic study of FYB206, a biosimilar candidate to Merck's cancer drug Keytruda, met its primary endpoint.
The study demonstrated pharmacokinetic equivalence between FYB206 and Keytruda, which had generated global sales of $31.7 billion in 2025.
Formycon said it will now focus on completing remaining development activities and finalizing regulatory submission documents, working with authorities to make FYB206 available after the reference product's exclusivity expires.
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