Sun Pharma wins approval to launch generic Ozempic

JOHANNESBURG, July 15: India’s Sun Pharmaceutical Industries has received approval from South Africa’s health regulator to manufacture and ​sell a generic version of semaglutide, the active ingredient ‌in Novo Nordisk’s top-selling diabetes and obesity drugs.

Novo’s patent on semaglutide – used in diabetes drug Ozempic and weight-loss treatment Wegovy – expired in March, ​prompting expectations of a wave of cheaper generics ​from local and international drugmakers.

The entry of generics also ⁠poses a challenge to U.S. company Eli Lilly, which has ​launched blockbuster diabetes and obesity drugs in South Africa as ​well.

The approval from the South African Health Products Regulatory Authority makes South Africa the second market, after India, where Sun Pharma has secured ​clearance for a generic semaglutide injection, the company said in ​a statement.

The approval is for adults with inadequately controlled type 2 diabetes.

Sun ‌Pharma ⁠said it plans to launch the product in South Africa in the coming days. The drug will be sold as a pre-filled, multi-dose injectable pen in two strengths — 2 mg ​and 4 mg — ​for once-weekly ⁠use.

“We remain committed to improving access to generics and making evidence-based treatment options available to ​patients and healthcare professionals,” said Sun Pharma’s Chief ​Operating ⁠Officer Aalok Shanghvi.

South Africa’s weight-loss drug market is dominated by Eli Lilly’s Mounjaro and Novo’s Ozempic and Wegovy, although the products ⁠face ​growing competition from compounded versions of the medicines.

Regulators ​have been increasing efforts to monitor and regulate the compounded-drug market amid strong ​demand for low-cost treatments.