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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.
Consequences of counterfeit pharmaceutical product sales
Recently, both the FDA and EMA have raised concerns about counterfeit drug products, including GLP-1s used for weight loss and diabetes, being marketed in the...