Brand, Generic Disputes Over Access Move Beyond REMS Restrictions

Generic companies say innovators are using voluntary restricted distribution programs to prevent them from obtaining reference drugs for bioequivalence testing; a July hearing is set in a dispute involving Actelion’s Gaucher disease drug Zavesca, which is not subject to a Risk Evaluation and Mitigation Strategy.

The growing tension between the innovator and generic drug industries over access to branded products for bioequivalence testing is moving beyond the framework of restricted distribution programs under Risk Evaluation and Mitigation Strategies.

Legal disputes are on the rise in which generic drug manufacturers assert the brand company has used a voluntary restricted...

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