HYDERABAD, India — While generic versions of the most popular GLP-1 drugs are not expected in the U.S. until at least 2031, Dr Reddy’s Laboratories already intends to roll out a generic version of Novo Nordisk’s Wegovy (semaglutide) at a steep discount.
A price up to three-fifths off the branded price is feasible, said co-chairman and managing director G.V. Prasad.
In India, Wegovy costs just less than $120 a month for the 0.25 mg dose and over $180 for 2.4 mg dose.
The patent for semaglutide in India expires next month. Dr Reddy's in January was cleared by India's regulatory drug authority to make and market a generic version of Novo Nordisk's Ozempic (semaglutide), and said that it was awaiting clearance for a generic of Wegovy. The company seeks to sell 12 million injectable semaglutide pens in the first year of the introduction.
Dr. Reddy’s also reported that the Food and Drug Administration has accepted for review its biologics license application (BLA) for DRL_AB, a proposed interchangeable biosimilar to Orencia (abatacept).
"We are proud to be the first to submit a BLA for an abatacept biosimilar which marks a significant milestone in our mission to increase patient access to critical, high-quality biologic therapies," said Milan Kalawadia, Dr. Reddy's North American CEO. “We look forward to working with the FDA to bring this in-house developed biosimilar to market as a cost-effective alternative for patients and healthcare providers in the United States."
DRL_AB could be administered as an IV for infusion formulation for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA), adults with active psoriatic arthritis (PsA), and individuals aged six years and older with moderately-to-severely active polyarticular juvenile idiopathic arthritis (pJIA).
The BLA submission includes a comprehensive data package consisting of analytical, pharmacokinetic (PK), and clinical studies.
Prasad said Dr Reddy's is also seeking clearance to introduce a biosimilar for Genentech and Biogen's cancer therapy Rituxan (rituximab) in the U.S.
