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NVO - FDA implements new rule aimed at boosting competition in insulin
Novo Nordisk A/S
Effective March 20, the FDA will institute a new rule that marketing applications for biologics, including insulins, will be regarded as licenses under the Public Health Service Act, enabling the filing of applications for biosimilars. The agency says the rule should enhance the transition from branded products to biosimilar and interchangeable products thereby opening up the U.S. market to competition.
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