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Smart & Biggar

Update on biosimilars in Canada – June 2025

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This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access—since our March 2024 update. Consultation on revised biosimilar...more

Venable LLP

May 2025 Stelara® and Humira® Interchangeable Biosimilar Approvals

Venable LLP on

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

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Patent Listings and Other Information Coming to the Purple Book

Rothwell, Figg, Ernst & Manbeck, P.C. on

The COVID-19 relief and spending bill signed into law on December 27, 2020, includes a provision – Division BB, Title III, Subtitle C, Section 325[1] – that adds a new paragraph 9 to 42 U.S.C. §262(k) requiring the U.S. Food...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

Goodwin

Legislative Update: State Biosimilar Substitution Laws

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More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and...more

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