FDA reviews a proposed Keytruda biosimilar, Roche expands its obesity pipeline with an RNAi deal, and guselkumab shows promise for fistula remission in Crohn disease.
News|Articles|September 21, 2026
Why early development assessment is essential in modern biologics development
Author(s)Lonza
In biologics development, a strong scientific idea is only the beginning. A molecule may show compelling biology in discovery, demonstrate good target engagement, and generate early excitement internally or with investors, but none of this guarantees that it can become a safe, manufacturable, and clinically viable therapeutic. That is the reality many early-stage companies face, and it is exactly why early development assessment matters. Early drug development is complex, multidisciplinary, and shaped by interdependent decisions. Data from discovery, drug substance, drug product, immunology, analytics, safety, and regulatory activities must ultimately come together in the first-in-human enabling package. Read this content piece to explore how at Lonza, these connected workstreams are assessed in a coordinated way, helping teams build a more complete and decision-ready foundation for development.
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