Generic Drugs as an alternative to Semaglutide

Why in News?

Patent expiry of Semaglutide has enabled launch of multiple generic versions in India with prices reduced by 70–90%.

Obesity

• It is a chronic disease due to excess accumulation of body fat that affects health, often defined by a Body Mass Index (BMI) of 30 or higher.
• It is driven by genetic, socioeconomic, and lifestyle factors primarily consuming more calories than are burned.
• Health Risks - It is associated with serious conditions, including cardiovascular disease, type 2 diabetes, high blood pressure, high cholesterol, liver disease, sleep apnea, and various cancers.

Type 2 diabetes is a major health crisis in India, with an estimated 77–101 million adults suffering from the condition, making it the world’s "diabetic capital".

Semaglutide

• Semaglutide is a prescription drug used for type 2 diabetes and obesity management.
• Drug Class - GLP-1 receptor agonist (Glucagon-Like Peptide-1).
• Uses-Type 2 diabetes management and Obesity and long-term weight control.
• Comparator Drug - Tirzepatide (dual GIP/GLP-1 agonist).
• Global Context - One of the fastest-growing drugs worldwide, relevant for pharma economics.
• Mechanism of Semaglutide – Mimic GLP-1 hormone, reduce hunger signals and increase satiety.
• Leads to lower calorie intake and gradual weight loss.

Generic Medicines

• Drugs that are bioequivalent to branded (innovator) medicines, with the same active ingredient, dosage, safety, and efficacy.
• Regulated by - Central Drugs Standard Control Organisation (CDSCO).
• Patent Rules
  • Enter market after patent expiry.
  • Governed under WTO–TRIPS Agreement.
  • Patent duration - 20 years from filing date.
  • India’s Patents Act, 1970 (Section 3d) prevents “evergreening” of patents.
• Jan Aushadhi Scheme - Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) provides affordable generics through government-run outlets.
• Some Generic drugs used as alternative for semaglutide - Semanat Semafull, Semaglyn, Mashema, Alterme, and Noveltreat.
• Easy-to-inject pen devices - Semanext, Livarise, and Sembolic.

Reference

Indian Express | Semaglutide