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Interchangeability New Regulations

Venable LLP

May 2025 Stelara® and Humira® Interchangeable Biosimilar Approvals

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In May 2025, the FDA approved numerous biosimilars as interchangeable with Stelara® (ustekinumab) and Humira® (adalimumab), bringing the total number of Stelara® interchangeables to four, plus an additional biosimilar (Sandoz...more

Goodwin

Wisconsin and West Virginia Pass Biosimilar Legislation

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Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products. Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on...more

Goodwin

South Dakota Passes Automatic Substitution Law for Interchangeable Biosimilars

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South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product. According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the...more

Goodwin

Year in Review: Top Five Legal Developments of 2017

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Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Goodwin

Nebraska Enacts Law To Allow Automatic Substitution Of Interchangeable Biosimilars

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As we previously reported, the Nebraska legislature had been considering a bill that would allow automatic substitution of “interchangeable” biosimilar products where a physician prescribes a biologic product. Last month, the...more

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