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Generic-drug makers sue brand-name companies for product samples

Refusal to sell samples for bioequivalence testing violates antitrust laws, generics say

The battle between generic and brand-name drug companies has escalated.

The latest litigation involves allegations that brand-name drug makers are refusing to sell product samples to generic-drug companies for bioequivalence testing—testing that determines whether the generic version of a drug is the exact replica of the brand-name version. Food and Drug Administration regulations require generic makers to complete such testing to prove that their drugs have the same biological effects as their brand-name counterparts. Generic-drug companies claim their brand-name rivals’ refusal to sell samples prevents them from completing the required testing and violates antitrust laws.

Ashley Post

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