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Biosimilar Labeling: FDA Says Leave Comparability Data Out

 
• By Derrick Gingery

Data developed to show no clinically meaningful differences with the reference product could confuse prescribers, agency says in new draft guidance.

Biosimilar labeling generally should not include the clinical data that 351(k) sponsors used to gain approval unless necessary for the product's safe and effective use because they may be confusing to prescribers, FDA said.

A new draft guidance released March 31 states that biosimilar product labeling should instead describe the clinical efficacy...

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More from United States

340B Reform Advocates Hail CBO Report, But ‘Scoreable’ Savings Still In Doubt

 
• By Michael McCaughan

The 340B program increases federal health care costs by encouraging the use of costlier medications, the Congressional Budget Office said. But the agency also did not provide a specific estimate of the impact.

Stealth’s Forzinity Accelerated Approval Shows US FDA Confirmatory Trial Status Flexibility

 
• By Sue Sutter

Stealth has until March 2026 to begin enrolling its confirmatory trial for its Barth syndrome drug elamipretide, marking a rare instance where a novel drug received accelerated approval even though the required postmarketing study was not underway.

ACIP Weakened COVID-19 Vaccine Advice, But Less Than Rhetoric May Suggest

 
• By Sarah Karlin-Smith

The new recommendations should not change insurance coverage, but the tone of the meeting frustrated many medical experts, because of the negative comments on the vaccines.

Inexperience And Confusion: ACIP Struggles To End MMRV, Hep B Debates

 
• By Bridget Silverman

Confusion, inconsistency and strongly held views complicated the CDC's Advisory Committee on Immunization Practices' votes to change vaccine recommendations for the measles, mumps, rubella, varicella vaccine in young children and tabling of a vote on hepatitis B vaccine at birth.

More from North America

US FDA Appears To Be Managing MAHA Well By Feeding Instead Of Receiving Priorities

 
• By Ramsey Baghdadi

The newly issued Make America Healthy Again strategy report suggests that FDA leaders are doing a good job of feeding ideas to the Trump Administration, rather than having the agency agenda dictated from above.

Stakeholders Warn Medicare Payment Proposals For Cell, Gene Therapy Could Hamper Access

 
• By Cathy Kelly

CMS proposals would reduce Medicare payments for cell and gene therapy manufacturing and preparation, which will further disincentivize outpatient or community-based treatment, advocates and sponsors said.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.