Biological products, including biosimilar and interchangeable biosimilars, are large and generally complex molecules.  A biological product may weigh more than 800 times than a drug product (e.g., aspirin).  See the figure below.

Who is the audience for this webpage?

FDA’s biological product-specific labeling resources on this webpage are primarily directed to industry staff who develop prescription labeling for biological products. For additional prescription drug labeling resources for industry such as those for the Prescribing Information, FDA-approved patient labeling, carton and container labeling, generic drug labeling, labeling databases, and product databases visit FDA’s Labeling Resources for Human Prescription Drugs. If you are a healthcare professional, patient, or caregiver, visit Frequently Asked Questions about Labeling for Prescription Medicines.

Biosimilar and Interchangeable Biosimilar Labeling Guidances

• Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1) (draft guidance) 
• Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed (draft guidance) 
• Labeling for Biosimilar and Interchangeable Biosimilar Products (draft guidance)

Deemed BLAs Guidance

• The “Deemed to be a License” Provision of the BPCI Act - Questions and Answers (final guidance) 

Nonproprietary Nomenclature of Biological Products Guidances and MAPP

• Nonproprietary Naming of Biological Products (final guidance – January 2017)
• Nonproprietary Naming of Biological Products: Update (draft guidance – March 2019)
• Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351 of the PHS Act MAPP

Other Biological Product-Specific Labeling Resources

• Biosimilar Product Information: Includes a list and information about all FDA-licensed biosimilar products in the U.S.
• Biosimilars: Labeling, Scientific, Regulatory, and Clinical Considerations for Health Care Providers (June 2023 presentation)
• Classification Categories for Certain Supplements Under BsUFA III (draft guidance)
• Deemed BLA Database includes a list of applications for biological products under section 505 of the Federal Food, Drug, and Cosmetic Act was deemed to be a license for the biological product under section 351 of the Public Health Service Act.
• Labeling for Biological Products (December 2019 presentation and video) and (June 2019 presentation) 
• Purple Book is a searchable online database that contains information about biological products licensed by the FDA under the Public Health Service Act including therapeutic biological products, vaccines, allergenic products, blood products, cellular and gene therapy products, and plasma derivatives.

Contact Information

For specific application or supplement questions or for general questions about prescription drug labeling, please visit Prescription Drug Labeling Contact Information.