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The US approach to biosimilars explained

Eileen McDermott, New York


The FDA’s draft guidance for biosimilars has provided some clarity for biosimilar applicants and innovator biologic companies. But lawyers say many questions remain

The guidance was released last week on the Federal Drug Adminsitration’s website, but has not yet been published in the Federal Register. The comment period will not begin until the Federal Register Notice is announced.

The United States paved...


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