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Biosimilar Competition: How Might FDA Be Convinced To Change Its Naming Policy?

Executive Summary

Following FDA/FTC workshop, several stakeholders urge FDA to do away with suffixes for biosimilar names while others seek reconsideration of switching studies for interchangeability.

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FDA/FTC's Hot Ticket: Biosimilar Workshop On How To Boost Market, From Education To Lawsuits

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Payers are driving the selection of reference products or biosimilars, creating an ‘artificial interchangeability’ unlikely to be affected by the actual regulatory designation, industry reps say; former FDA commissioner Scott Gottlieb says misinformation campaigns around biosimilar and interchangeable products may lead to enforcement by the FDA and Federal Trade Commission.

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