In a decision with implications for health care costs, a federal appeals court ruled drug makers cannot use state laws to punish their biosimilar rivals from withholding information about their medicines.
The ruling came in response to opposing views of a procedure found in the Biologics Price Competition and Innovation Act, which is supposed to determine when biosimilar drugs can be launched. A biosimilar drug is a nearly identical variant of a biologic and is expected to provide the same result in patients.
Such disputes are being closely watched, because biosimilars are forecast to save between $27 billion and $58 billion in health care costs by 2021, according to IQVIA, a market research firm. Only eight have so far been approved by regulators, but they are expected to cost about 20 percent less than biologics.