Spotlight on CDER Science
Safety Outcomes When “Switching” Between Biosimilars and Reference Products
Biological products (biologics) play an important role in clinical care, providing safe and effective treatments for many disorders. They are a diverse category of products that include vaccines, proteins (such as insulins, monoclonal antibodies, and growth factors), as well as blood and blood products.
Previous Spotlight on CDER Science Articles
2023
- Safety Outcomes When “Switching” Between Biosimilars and Reference Products
- Computational Simulations Shed Light on Factors Affecting Nasal Spray Distribution
- Bispecific Antibodies: An Area of Research and Clinical Applications
- Laboratory Study Shows Oral Antacid Drug Performs Differently When Mixed with Various Food Vehicles
- Using Patient-Reported Outcomes to Measure Frailty in Patients with Multiple Myeloma
- The Role of Disclosures: Helping to Understand Oncology Clinical Trial Endpoints
- Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development
2022
- Assessing the Respiratory Effects of Approved Opioid Products When Co-administered with Commonly Prescribed Drugs
- A Real-World Case Study of Levothyroxine Use Addresses Institutional Concerns About Generic Product Interchangeability
- Learning from Patient Text Messaging to Optimize Opioid Prescribing and Reduce Misuse
2021
- First-of-kind Pediatric ECG Data Warehouse for Use in Pediatric Product Development Programs and Prevention of Sudden Cardiac Death in the Young
- Ensuring the Rigor of Regulatory Science: CDER Conducts Laboratory and Clinical Studies to Investigate Reports of NDMA Production from Ingested Ranitidine Products
2020
- Remdesivir (Veklury) Approval for the Treatment of COVID-19—The Evidence for Safety and Efficacy
- Real-world Evidence from a Narrow Therapeutic Index Product (Levothyroxine) Reflects the Therapeutic Equivalence of Generic Drug Products
- Promoting Innovation in Medical Product Assessment: A Risk-based Framework for Evaluating Computational Models for Regulatory Decision-Making
- Rigorous Detection of Nitrosamine Contaminants in Metformin Products: Balancing Product Safety and Product Accessibility
- Translating In Vitro Antiviral Activity to the In Vivo Setting: A Crucial Step in Fighting COVID-19
2019
- Assessing effects of drugs in wastewater on aquatic wildlife
- New FDA Study Shines Light on Sunscreen Absorption
- A Novel Mouse Model Offers Insights About Hypersensitivity to an HIV Drug
- New Drug Class Employs Novel Mechanism for Migraine Treatment and Prevention
2018
- CDER Scientists Investigate Critical Cellular Functions That Can Be Targeted to Kill Cancer Cells
- New Class of Drugs Fulfills Promise of RNA-based Medicine
- Advancing the Science of Nanotechnology in Drug Development
- CDER Scientists Use Modern Measurement Tools for Quality Assurance and Comparability of Complex Drugs
2017
- CDER Researchers Explore the Promise and Potential of 3D Printed Pharmaceuticals
- In Pursuit of Tardive Dyskinesia: The Breakthrough Designation and Approval of Valbenazine
- FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products
- Lab Tests in Rodents Suggest Potential New Biomarker for Acute Pancreatic Injury
- Novel Approach Allows Expansion of Indication for Cystic Fibrosis Drug
- Modernizing the Way Drugs Are Made: A Transition to Continuous Manufacturing
- Tuberculosis Biorepository Aims To Bolster TB Drug Development by Facilitating Research on Biomarkers