In a move that may have significant implications for health care costs, Sandoz has asked the US Supreme Court to resolve a contentious dispute over a rule for launching biosimilars. Specifically, Sandoz wants the court to decide when a drug maker that wants to sell a biosimilar medicine must give notice to the manufacturer of the brand-name version about its product launch.
At issue is the ability of brand-name drug makers to delay the introduction of biosimilars, which are highly identical versions of expensive biologics. And a great deal is at stake for patients, payers, and drug companies because biosimilars are forecast to save an estimated $44 billion in US health care costs over the next decade. Most analysts and payers forecast that biosimilars will cost 10 percent to 30 percent less than the brand-name biologics.
Sandoz, which is the generic unit of Novartis, hopes to resolve a legal battle that has been under way concerning the notice that a brand-name company is entitled to receive.
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