The FDA has taken two coordinated steps aimed at expanding generic drug competition and improving patient access to lower-cost medicines, publishing a final guidance on therapeutic equivalence evaluations alongside a new batch of 55 product-specific guidances (PSGs) for generic drug development.
Final Guidance Clarifies Therapeutic Equivalence Process
FDA published its final guidance for industry, Evaluation of Therapeutic Equivalence, which revises and finalizes the draft version issued in July 2022. The guidance clarifies the process by which certain applicants may request therapeutic equivalence (TE) codes and explains how FDA conducts its TE evaluations, including the assignment of those codes.
Therapeutic equivalents are approved drug products that FDA has determined to be pharmaceutical equivalents for which bioequivalence has been demonstrated, and which are equally safe and effective for patients when used according to their labeling. TE evaluations are compiled in Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the "Orange Book," which helps determine when drug products may be substituted for one another. The evaluations serve as public information for state health agencies, prescribers, and pharmacists to support informed drug product selection. FDA noted that when lower-cost, therapeutically equivalent drug products are available, American consumers gain more treatment options with the same safety, efficacy, and quality.
New Batch of Product-Specific Guidances Targets Complex and High-Priority Products
Separately, FDA published a new batch of draft product-specific guidances for developing generic drugs and generating evidence to support abbreviated new drug applications (ANDAs). PSGs are intended to facilitate generic drug development, streamline ANDA assessment, and support access to generic drugs that meet the same high-quality, safety, and effectiveness standards as their brand-name counterparts.
Today's batch includes 55 PSGs: more than 30 for products with no approved ANDAs (including 15 for complex products), 24 new and 31 revised guidances overall, and 18 addressing complex products (7 new and 11 revised). The batch covers products including:
- Targeted oncology oral kinase inhibitors approved for specific types of non-small cell lung cancer (NSCLC), reflecting continued advancement in precision oncology
- A first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor — the first and currently only approved treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and adolescents — representing a breakthrough for a chronic lung disease with no prior FDA-approved therapies
- A poly (ADP-ribose) polymerase (PARP) inhibitor, a pioneering approval particularly for BRCA-mutated cancers that helped establish the regulatory framework for biomarker-driven cancer therapies
The batch also includes guidance supported by GDUFA-funded research, such as a revised PSG for ferumoxytol injection (FERABRIGHT, NDA 219868) with new bioequivalence recommendations and additional physicochemical characterization tests, and a new PSG for benzoyl peroxide; tretinoin topical cream (TWYNEO, NDA 214902) recommending in vitro bioequivalence studies and other characterization tests as an alternative to a comparative clinical endpoint bioequivalence study.
Once finalized, the PSGs will describe FDA's current thinking and recommendations for developing generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all public docket comments before finalizing PSGs.
Part of Broader Drug Competition Action Plan
Both actions were published as part of FDA's Drug Competition Action Plan, which aims to facilitate generic competition, promote patient access, and improve health care costs. The product-specific guidance batch also advances the goals of President Trump's Executive Order 14273, "Lowering Drug Prices by Once Again Putting Americans First," by accelerating the development and approval of generic drugs.
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