Description
This guidance provides recommendations to applicants seeking licensure under section 351(k) of the Public Health Service (PHS) Act of a proposed biosimilar or proposed interchangeable biosimilar for fewer than all of the reference product’s licensed conditions of use. This guidance also provides recommendations on the submission of a supplement to a licensed 351(k) biologics license application (BLA) seeking to add a condition of use that previously has been licensed for the reference product to the labeling of a licensed biosimilar or interchangeable product, including considerations related to the timing of such submissions.
Scope & Applicability
Product Classes
2A biosimilar product determined to be interchangeable with the reference product.; may be substituted for the reference product without the intervention of the prescribing health care provider
Biological product shown to be highly similar to an FDA-licensed reference product; Biological product demonstrated to be highly similar to a reference product
Stakeholders
1Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
4before any applicable BsUFA goal date or 6-month targeted review timeline
characterizing the safety of individual drugs
The state of being interchangeable with a reference product
The state of being biosimilar to a reference product
Identified Hazards
Hazards
1safety information required in labeling
Related CFR Sections (5)
- 21CFR316.31§ 316.31 Scope of orphan-drug exclusive approval.
(a) FDA may approve a sponsor's marketing application for a designated orphan drug for use in the rare disease or condition for which the drug was designated, or for select indication(s) or use(s) within the rare disease or condition for which the drug was designated. Unless FDA previously approved Read full regulation →
- 21CFR201.100§ 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act shall be exempt from section 502(f)(1) if all the following conditions are met:Read full regulation →
- 21CFR601.12§ 601.12 Changes to an approved application.
(a) General.Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.
(a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →
Related Warning Letters (5)
- 2025-01-28
Unapproved New Drugs/Misbranded
Mihon Corp. d/b/a VitalityVita and Boulla, LLC
- 2023-12-26
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
East Fork Cultivars
- 2023-03-14
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
ElectRx and Health Solutions, LLC
- 2023-01-17
Finished Pharmaceuticals/Unapproved New Drug/Misbranded
HIS Enterprise Inc dba Adam’s Secret USA, LLC
- 2020-01-28
Unapproved New Drugs/Misbranded
Wave Miami LLC
See Also (8)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage Forms (Status: Final)
- Labeling for Biosimilar Products Guidance for Industry (Status: Final)
- Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry (Status: Draft)
- Labeling for Biosimilar and Interchangeable Biosimilar Products (Status: Draft)
- Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs (Status: Draft)
- Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers (Status: Final)
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (Status: Final)