The FDA’s recent approval of Hikma Pharmaceuticals’ generic version of Novo Nordisk’s diabetes drug Victoza, a once-daily GLP-1 receptor agonist injection, is a significant milestone. This drug, indicated for glycemic control in patients aged 10 years and above with type 2 diabetes, serves as an adjunct to diet and exercise.

Over 38 million Americans are affected by diabetes—90% to 95% of whom have type 2 diabetes—and liraglutide addresses glycemic imbalances by mimicking GLP-1 effects in the pancreas, which is often deficient in such patients. However, liraglutide and other GLP-1 medications currently face shortages. The FDA, recognizing this issue, has prioritized reviewing generic applications for drugs in short supply, as seen with its recent approval of exenatide (Byetta) by Amneal Pharmaceuticals and Teva’s earlier launch of an authorized generic version of Victoza in the U.S.

Developing complex drugs like liraglutide is challenging due to intricate active ingredients, formulations, and delivery methods, often resulting in limited generic competition. To address this, the FDA offers early regulatory guidance through industry advisories and the pre-ANDA program, streamlining the development and approval processes. These efforts aim to enhance access to complex medications, ensuring availability for patients in need.

IeB Perspective: Underscoring the growing opportunities in addressing drug shortages and advancing complex generics with limited competition, pharma companies and CROs should focus on innovative peptide-based therapeutics, proactive regulatory engagement, and leveraging FDA programs like pre-ANDA for accelerated approvals. The diabetes therapeutic space, with significant unmet needs, offers immense growth potential, particularly for advanced drug-device combinations. Aligning with global regulatory frameworks can further enhance market access and patient reach worldwide.

Need tailored insights and a strategic roadmap that aligns with your business milestones? Connect with our healthcare domain experts and professionals by filling out the form below or emailing them at contact@iebrain.com.