On September 18, 2023, the FDA (Food and Drug Administration) announced the availability of a draft guidance for industry entitled “Labeling for Biosimilar and Interchangeable Biosimilar Products.” This draft guidance is intended to describe proposed labeling requirements for biosimilar and interchangeable biosimilar products. Per the FDA, “the recommendations for biosimilar and interchangeable biosimilar product labeling in this draft guidance pertain only to the prescribing information, except for certain recommendations pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, Instructions for Use). When finalized, this draft guidance will revise and replace the guidance for industry entitled “Labeling for Biosimilar Products.”[1]
Our first post reviewed the FDA’s proposed recommendations regarding the inclusion or exclusion of FDA’s Purple Book assignments for biologicals within product’s Prescribing Information (PI). This post will provide a general description of the remaining recommended changes to biosimilars’ PI. The important date to remember is November 17, 2023, which is the last day the FDA will receive comments concerning the recommendations. PHSL is providing a summary of the FDA’s proposal and strongly recommends reading the entire publication to accurately evaluate the impact to biosimilar labeling for existing products and for those products anticipating FDA approval in the near future.
PHSL assists companies in staying up to date on the inherent complexity of the Purple Book and biologicals, which includes biological naming conventions and their impact on prescribing and dispensing. PHSL can provide an independent evaluation of the FDA’s proposal on biological products PI and can assist in crafting a company’s response to the proposed guidelines with the November 17 deadline in sight.
Major Proposed Changes
The FDA identified four significant changes from the previous July 2018 Guidance “Labeling for Biosimilar Products”.[2]
- “Labeling for interchangeable biosimilar products
- Product identification when the reference product labeling describes a clinical study conducted with a non-U.S.-approved biological product.
- Pediatric use statements
- Incorporating relevant immunogenicity data and information from the reference product labeling in the biosimilar or interchangeable biosimilar product labeling.”
Key Sections
PHSL has summarized key sections of the FDA’s proposals on biosimilar product labeling, as follows:
Section IV. SPECIFIC RECOMMENDATIONS ON CONTENT OF BIOSIMILAR AND 160 INTERCHANGEABLE BIOSIMILAR PRODUCT
- Recommended Approaches to Product Identification
PHSL Summary: This section identifies when and where in the PI each of the following may be used: product name, biosimilar name, or a core name + products. Each section includes a sample, using a hypothetical drug product and its biosimilar:
- “When to Use the Biosimilar or Interchangeable Biosimilar Product Name
- When to Use the Reference Product Name
- When to Use the Core Name Followed by the Word ‘Products’
- When to Use More Than One Product Identification Approach
- When the Reference Product Labeling Describes a Clinical Study Conducted With a Non-U.S.-Approved Biological Product”[3]
To recap, the following example contained in the draft guidance helps illustrate these naming conventions.
Key (hypothetical product)
Reference Product Name: JUMEXANT (replicamab-hjxf)
Biosimilar Product Name: NEXSYMEO (replicamab-cznm)
Core Name + Products: replicamab products
- Recommended Approaches to Content Presentation
PHSL Summary: The FDA describes proposed guidance to address complex situations surrounding biosimilars, such as shared clinical studies or approvals for different indications. This guidance covers several aspects of the content of the PI, including Boxed Warnings, Contraindications, Warnings and Precautions, Adverse Reactions, Drug Interactions, and Use in Specific Populations. The FDA provides multiple examples for each issue. For manufacturers, PHSL recommends your organization conduct a thorough review to determine the potential impact on your products’ labeling.
- Recommended Approaches to Specific Sections of Biosimilar and Interchangeable Biosimilar Product Labeling (covered in previous blog post)
PHSL Summary: The FDA wants to have a consistent approach with all biosimilar and interchangeable biosimilar product labeling. The proposed guidance details the FDA recommendations on how a biosimilar or interchangeable is described in the PI, including the naming conventions and how approval for different indications will impact the language contained in the PI. This section covers the Highlights section of the PI, including a Biosimilarity statement, Indications and Usage, Use in Specific Populations (specifically Pediatric Use Subsection), and Clinical Pharmacology/Immunogenicity.
Section V FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar Products.
PHSL Summary: This section covers recommended changes to patient labeling including Medication Guides, Patient Information, and Instructions for Use. The changes are specific to the terminology used to describe the reference product and the biosimilar within patient-centric sections of the PI.
Section VI and VII are specific guidelines for when and how the FDA requires revisions of the PI. This section is important to review. as it describes the FDA’s approach to the PI when a biosimilar obtains different indications than the reference product.
Contact PHSL to discuss how these changes impact your organization and to prepare a response to share your input with the FDA during this critical time period.
Posted: October 2023
[1] Federal Register: Labeling for Biosimilar and Interchangeable Products; Draft Guidance for Industry; Availability. 9/15/2023
[2]Email 9/18/2023: FDA Releases a New Draft Guidance on Labeling for Biosimilar and Interchangeable Biosimilar Products – Drug Information Update
[3] Federal Register: Labeling for Biosimilar and Interchangeable Products; Draft Guidance for Industry; Availability. 9/15/2023