News & Analysis as of

Final Guidance Biosimilars Life Sciences

McDermott Will & Emery

Preparing for 2025: Key Trends in FDA Guidance Agendas

McDermott Will & Emery on

In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more

Foley Hoag LLP

FDA Updates Select Q&As on Biosimilar Regulation

Foley Hoag LLP on

The Food and Drug Administration (FDA) updated a final guidance and a companion draft guidance (the “first draft guidance”) providing answers to questions related to the agency’s regulation of biosimilar products and its...more

Wilson Sonsini Goodrich & Rosati

FDA Releases Final Guidance: Transition of Previously Approved Drugs to Being "Deemed Licensed" Biologics

U.S. prescription drugs can broadly be divided into two categories: 1) small molecule drugs and 2) biologics. Small molecule drugs tend to be chemically synthesized and often have molecular weights under 1,000 Daltons....more

Kramer Levin Naftalis & Frankel LLP

Biosimilars in 2020: What’s Ahead

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more

Hogan Lovells

FDA guidance may ease path to biosimilar interchangeability

Hogan Lovells on

On Friday, FDA published the final guidance, “Considerations in Demonstrating Interchangeability With a Reference Product,” which is intended to assist sponsors in demonstrating that a biosimilar product is interchangeable...more

Morgan Lewis

New Approach for Biologic and Biosimilar Names

Morgan Lewis on

FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products (Naming Guidance)....more

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