From Our Perspective
Insights from CDER leadership and experts on public health actions
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
By Sarah Yim, M.D., director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars
Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and their patients. We have also gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products (interchangeable biosimilars). The recommendations in our draft labeling guidance reflect this experience and have been revised to specifically include interchangeable biosimilar products.
Previous From Our Perspectives
2023
- Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
- CDER Takes Measures to Tackle Stimulant Use Disorder
- CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
- CDER’s Efforts to Expand Opioid Disposal Options
- FDA actions to continue to ensure the safety of the nation’s drug supply
- CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program
- From Our Perspective: CDER’s Continued Efforts to Widen Naloxone Access
- From Our Perspective: Risk Evaluation and Mitigation Strategies (REMS), Part 2 - Implementation: Challenges and Opportunities
- A Two-Part Series: Risk Evaluation and Mitigation Strategies (REMS) Program
2022
- FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time
- FDA Issues Draft Guidances on Real-World Evidence, Prepares to Publish More in Future
2021
- 50 Years of Progress in Treating Patients with Cancer
- FDA Holds Workshop to Discuss the Safe Use of Benzodiazepines
- FDA Approval Demonstrates the Role of Real-World Evidence in Regulatory Decision-Making on Drug Effectiveness
- CURE ID Moves to Automated Data Collection in Light of COVID Pandemic
- FDA’s Decision to Approve New Treatment for Alzheimer’s Disease
- Generic Drugs in the 21st Century: FDA’s Actions Create Transparency and Value for Complex Generic Product Development
- FDA and Duke-Margolis Host Workshop on Scientific and Ethical Considerations for Including Pregnant People in Clinical Trials
2020
- The Orange Book at 40: A valued FDA resource continually enhanced by user input
- Bad Ad Program at 10, Educating Healthcare Providers to Recognize and Report Potentially False or Misleading Prescription Drug Promotion
2017
2016
- Biosimilar product labeling with Dr. Leah Christl
- Encouraging drug development for rare diseases with Dr. Jonathan Goldsmith
- Working to prevent proprietary drug name confusion with Dr. Lubna Merchant
- Expedited oncology drug approvals with Dr. Richard Pazdur
2015
- Helping to Ensure the safety and effectiveness of sunscreens with Dr. Theresa Michele
- The importance of the physical characteristics of generic drugs with Dr. John R. Peters
- Atrial fibrillation, oral anticoagulant drugs, and their reversal agents with Dr. Ellis Unger
- The U.S. drug supply chain and patient safety with Dr. Ilisa Bernstein
- Patients deserve quality medications with Dr. Lawrence Yu
2014
- Statisticians at CDER Part 1, roles and responsibilities with Dr. Lisa LaVange
- Statisticians at CDER Part 2, activities outside of applications with Dr. Lisa LaVange
- Clinical biomarker qualification with Dr. Shashi Amur
- Atrial fibrillation and new oral anticoagulant drugs
2012