First Consolidation of Global Generic Development Standards

The U.S. Food and Drug Administration (FDA) adopted the International Council for Harmonisation (ICH) M13A final guideline on October 31, 2024. This reflects the document finalized by the ICH Harmonization Committee in Step 4 in July 2024, incorporating it into the U.S. regulatory system. It applies to bioequivalence (BE) standards for generic drug approvals and post-approval changes, rather than new drug approvals or Phase 1, 2, and 3 clinical trials. The FDA-led Generic Drug Cluster, launched in 2021, celebrated its third anniversary in June 2024 and operates a data-sharing program with Health Canada. This regulatory infrastructure aims to reduce the time and clinical trial costs for companies developing the same product for multiple regions by minimizing differences in study design across countries.

Reduced Testing Burden for 814 Products

M13A addresses the pharmacokinetics (PK)-based BE study design and analysis for immediate-release tablets, capsules, and granules/powders for oral suspension intended for systemic circulation. On the same day, the FDA revised the guidance for 814 individual products (PSG), re-evaluating high-risk and low-risk products and shifting the recommendation to perform both fasting and fed studies for these products to a focus on either condition. A randomized, single-dose, crossover study and the use of the highest marketed strength are standard, and some products can also utilize biopharmaceutical classification system (BCS)-based waivers. Subsequent M13B will address waiver criteria for additional strengths, and M13C will cover highly variable drugs, drugs with a narrow therapeutic index, and complex study designs, gradually expanding the scope of application.

Changes in the Prescription Market and Competitive Landscape

In the U.S., generics account for approximately 91% of dispensed prescriptions and only about 18% of drug costs, meaning that development efficiency directly impacts patient out-of-pocket costs and supply stability. According to FDA analysis, the 742 ANDAs fully approved in 2022 resulted in USD 18.9 billion in savings within 12 months of approval, with the first 32 generic products contributing USD 5.22 billion. M13A is not a regulation that relaxes approval standards but rather a system that ensures that the same safety, efficacy, and quality are demonstrated with more consistent data. Reducing redundant testing benefits not only large generic companies such as Amneal Pharmaceuticals (NYSE: AMRX), Torrent Pharmaceuticals (NSE: TORNTPHARM), and Lupin (NSE: LUPIN) but also smaller companies that are sensitive to development costs, improving their economic viability for market entry.

Commercial Effects Demonstrated by Latuda

The active ingredient in Latuda is lurasidone hydrochloride, a marketed atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A and 5-HT7 receptors. The FDA approved Sunovion Pharmaceuticals' NDA 200603 as a treatment for schizophrenia on October 28, 2010, and approved the first generic ANDAs from Amneal, InvaGen, Lupin, Accord Healthcare, and Torrent on January 3, 2019. This product line underwent therapeutic equivalence review of ANDAs rather than an advisory committee (AdComm) vote for the individual new drug, with competing treatments including marketed generic aripiprazole, quetiapine, and risperidone. After the launch of generics in early 2023, the average price in the market for over 325,000 prescriptions per month decreased by 96% from USD 47.71 to USD 1.87, with a 90% market share and USD 4.417 billion in savings in 12 months, demonstrating how regulatory efficiency translates into actual market restructuring.