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Lev Gerlovin, Ezra Josephson | Life Sciences
Let’s say interchangeability is a viable regulatory option for manufacturers of biosimilars. Would it always make sense to seek an interchangeability designation from a strategic perspective? Because of the diversity and complexity of product and manufacturer characteristics, there may not be a single optimal strategy, but rather a continuum. Click below to read the article.
Evidence requirements for orphan drugs
CRA’s Life Sciences Practice focuses on global policy, commercialization, and market access issues dedicated to orphan drug issues, including orphan evidence...