Are there biosimilar or interchangeable alternatives to tirzepatide approved or under review by the FDA?

1. What the FDA has actually approved for tirzepatide — only brand products

Tirzepatide is available in the United States as branded, FDA‑approved injections: Mounjaro for type 2 diabetes and Zepbound for chronic weight management ^{[1] [2] [6]}. The FDA and Eli Lilly materials cited describe these brand approvals and the clinical trials supporting Zepbound’s approval ^{[1] [2]}.

2. No biosimilars or interchangeability filings shown in these sources

The sources provided include the FDA’s biosimilar information pages and guidance on demonstrating biosimilarity, but none of the items in this set report an FDA licensure, application, or review of a biosimilar or interchangeable product referencing tirzepatide specifically ^{[7] [8]}. Available sources do not mention any specific biosimilar or interchangeable tirzepatide candidate under active FDA review.

3. What reporters and law firms covered instead — compounding and shortage policy

Coverage in these materials focuses on compounding pharmacies that made tirzepatide during supply constraints, litigation over the FDA’s shortage determinations, and the agency’s subsequent ramp‑down of enforcement discretion — not biosimilar approvals ^{[9] [3] [4] [10]}. NPR and other outlets reported that compounding of tirzepatide was permitted during a shortage but was required to stop when the FDA declared the shortage resolved ^{[5] [3]}.

4. Why compounding activity can be confused with “alternatives” — and why it’s not the same as a biosimilar

Compounded tirzepatide products were made by pharmacies to increase access during shortages, but they were not FDA‑approved generics or biosimilars; the FDA treats them differently and, when shortages are resolved, restricts that compounding activity ^{[5] [4]}. Compounded copies lack the approval pathway, interchangeability assessment, and Purple Book listing that biosimilars/interchangeables receive ^[7]. Reporting notes safety and legal concerns about compounded copies and subsequent enforcement and litigation ^{[5] [9]}.

5. Regulatory path and scientific hurdles for a tirzepatide biosimilar

The FDA’s biosimilar framework and recent guidance on demonstrating biosimilarity and the need for comparative efficacy studies outline complex requirements for large‑molecule therapeutics ^[8]. These documents explain the technical and clinical standards a sponsor would need to meet to obtain biosimilar or interchangeable status; none of the provided sources indicate that a sponsor has yet completed or filed such a program for tirzepatide ^[8].

6. Practical alternatives patients and clinicians are actually using today

In practice, reporting and health sites point patients to other FDA‑approved GLP‑1 or related therapies (semaglutide products, liraglutide, and other weight‑management drugs) or to branded tirzepatide (Mounjaro, Zepbound) rather than an approved biosimilar ^{[11] [12] [13]}. Sources stress that compounded products are not FDA‑approved and that courts and FDA actions have limited their availability after the shortage was deemed resolved ^{[5] [3] [4]}.

7. Conflicting viewpoints and potential industry motives in the coverage

Industry materials (e.g., law firm briefings and corporate releases) emphasize safety, quality control and the need to limit compounding of complex biologics — positions that protect brand‑manufacturer control and product standards ^{[9] [2]}. Compounding associations and some clinics argued for continued access to compounded tirzepatide during supply gaps, citing patient access concerns; litigation around the FDA’s shortage determinations reflects this conflict ^{[9] [10]}. These competing perspectives show both patient‑access arguments and manufacturer/regulator concerns about safety and product integrity ^{[9] [10]}.

8. Bottom line and what to watch next

Based on the provided reporting and FDA materials, there are no FDA‑approved biosimilar or interchangeable tirzepatide products currently identified in these sources — only branded Mounjaro and Zepbound — and the recent regulatory focus has been on compounding controls after a resolved shortage, not biosimilar approvals ^{[1] [2] [3] [4]}. To track any future biosimilar/interchangeable filings or approvals, consult the FDA’s Purple Book and the FDA biosimilar review pages for updates ^[7].

Limitations: these conclusions use only the documents and reporting you provided; if you want, I can search the FDA Purple Book and recent FDA press releases for any filings or approvals after these items to confirm whether a biosimilar application has since appeared.