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Biosimilars Food and Drug Administration (FDA) Regulatory Agencies

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

Guidance on Biosimilar Submission Requirements in Canada

Goodwin on

Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for...more

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