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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.
Potential impact of the CMS GENEROUS model
Reference country selection The model provided guidance on reference countries, defined by the G7 countries plus Denmark and Switzerland. Reference...