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In a development with widespread implications for health care costs, the US solicitor general recommended that the US Supreme Court review a heated dispute over a rule that will determine when lower-cost biosimilar medicines can be launched. And the solicitor general also took a position that may provide a boost to biosimilar manufacturers.

At issue is the ability of brand-name drug makers to delay the introduction of biosimilars, which are highly identical versions of expensive biologics, but are expected to cost less.

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The rule that the Supreme Court will review concerns the notice that a brand-name company is entitled to receive from a drug maker that wants to sell a biosimilar. The rule is found in a federal law known as the Biologics Price Competition and Innovation Act, which says a company seeking to sell a biosimilar must give the manufacturer of the brand-name biologic at least a 180-day notice before selling its drug (see page 10).

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