From Our Perspective
Education Efforts to Help Increase Biosimilar Understanding and Acceptance
By: Sarah Ikenberry, M.A., Senior Communication Advisor, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER
A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved biological product (biologic), as known as a reference product. Biosimilars are proven to be a safe and effective alternative to the reference product and may be offered at a lower cost.
Previous From Our Perspectives
2024
- Education Efforts to Help Increase Biosimilar Understanding and Acceptance
- CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients
2023
- FDA’s 50 Years of Experience with Cannabis Research Helping to Support Tomorrow’s Cannabis Drug Development
- 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
- CDER’s Continued Efforts to Widen Naloxone Access
- Risk Evaluation and Mitigation Strategies (REMS), Part 2 - Implementation: Challenges and Opportunities
- A Two-Part Series: Risk Evaluation and Mitigation Strategies (REMS) Program
End of Translation
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