Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry

Description

This guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act. The guidance discusses considerations for presenting data and information about reference products or biosimilar products in promotional communications to help ensure that they are accurate, truthful, and non-misleading.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

4

Biological Reference Product

Product licensed under section 351(a) of the PHS Act

Biosimilar Product

biological products shown to be biosimilar to a reference product

Interchangeable Biosimilar Product

biological products shown to be interchangeable with a reference product; Product type subject to labeling changes and supplement categories

Reference Product

The biological product to which a biosimilar is compared

Stakeholders

2

Manufacturer

Entity responsible for submitting NDINs

Health Care Provider

Physicians, veterinarians, dentists, and other licensed professionals

Regulatory Context

Regulatory Activities

3

351(k) Application

Application seeking licensure of a biological product as biosimilar or interchangeable

Licensure

Requirement for biological products under the PHS Act

Postmarketing Reporting

Requirement to submit HCEI to FDA at the time of initial dissemination.

Document Types

1

FDA-approved labeling

Describes findings of safety, purity, and potency

Attributes

4

Proprietary Name

Commercial name granted by an authority for marketing

Proper Name

Naming format for biological products in the combination regimen.

Core Name

component of the proper name

Safety, Purity, and Potency

Terms in which there must be no clinically meaningful differences; Standards required to be demonstrated for biological product licensure

Technical Details

Testing Methods

1

Comparative Clinical Study

Used to support demonstration of no clinically meaningful differences

Standards & References

Specifications

2

Dosage Form

Required information in promotional communications

Strength

Concentration of the active pharmaceutical ingredient

Related CFR Sections (5)

21CFR202.1§ 202.1 Prescription-drug advertisements.
Prescription drug as used in this section means any drug defined in section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act or § 201.105 of this chapter , applicable to drugs intended for use by humans and to veterinary drugs, respectively.Read full regulation →
21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
21CFR201.10§ 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the Federal Food, Drug, and Cosmetic Act shall appear together, without any intervening written, printed, or graphic matter, except the proprietary names of ingredients, which may be included with the listing of established names, and suchRead full regulation →
21CFR600.3§ 600.3 Definitions.
As used in this subchapter:Read full regulation →
21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

False or misleading risk presentation

8

Failure to submit under Form FDA-2253

5

Failure to use required established name

3

Omission of material facts

2

Misbranded drug

2

Misbranded

2

Failure to submit promotional materials

2

False or misleading claims about efficacy

2

Lack of fair balance

1

Omission of risk information

1