The Bengaluru-based agency has scored an early win amongst its friends with the UK approval for the primary generic model of liraglutide injectible, which is shedding patent safety in November.The load loss drug, offered underneath the model title Saxenda by patent holder Novo Nordisk A/S, is among the many first of the groundbreaking drugs on this class to lose patent safety.
Whereas Saxenda is much much less efficient for weight reduction than later iterations like Wegovy and Ozempic, its generic model is only the start of a jackpot that drug makers like Biocon are awaiting. “My management workforce and group is making certain that we don’t hand over the lead place we’ve now,” Chief Govt Officer Siddharth Mittal mentioned in an interview.
One other 15 peptide formulations are underneath improvement, of which one or two medicine will search regulatory approval this 12 months, he mentioned. Biocon has additionally filed functions earlier than the US and European regulators for liraglutide.
The corporate, helmed by Kiran Mazumdar Shaw, is main the cost amongst Indian drugmakers — the world’s largest provider of generic medicines — as they race to seize a slice of the weight problems medicine market. The worldwide frenzy round these medicines has already lured sector giants Solar Pharmaceutical Industries Ltd., Dr. Reddy’s Laboratories Ltd., and Cipla Ltd., who’re additionally creating their anti-obesity medicine.
Weight reduction medicine have already produced report revenue for progressive pharmaceutical firms from Novo Nordisk to Eli Lilly & Co. The gold rush is ready to unfold to generic makers like India’s largest gamers when patents expire within the coming years on Ozempic and Wegovy, permitting cheaper copies of the treatment to flood the market and plug provide gaps.
Novo Nordisk’s Ozempic and Wegovy are made with the identical lively ingredient, semaglutide, whereas Eli Lilly’s tirzepatide drug is offered as Zepbound. These, together with liraglutide, are a part of a category of medicines known as glucagon-like peptide 1, or GLP-1, agonists.
Biocon is constructing functionality “to make the most of what might be a really, very strategic peptide alternative with GLPs on the middle,” Group Chief Govt Officer Peter Bains advised analysts in November.
‘Very Complementary’
The lack of exclusivity for GLPs will create a multibillion greenback market over the subsequent 10 years and this chance was “very complementary” to Biocon’s present biologics enterprise, in line with Bains.
Within the UK, Mittal mentioned the corporate will look ahead to the publicly-funded, Nationwide Well being Providers, to drift a young to launch its liraglutide injectible. Biocon’s UK utility was filed by its European associate, Zentiva SA. The full addressable UK market alternative for GLP-1 in diabetes and weight reduction is $425 million, in line with a March 27 assertion by Biocon.
Regardless of the weight-loss section being a rage globally, these medicine are but to make an widescale look in India whose 1.4 billion-plus inhabitants is quickly getting extra prosperous and overweight.
Novo Nordisk, which solely sells its semaglutide-based capsule Rybelsus in India, is planning to introduce injectibles Wegovy and Ozempic in 2026, Reuters reported in February. Eli Lilly is conducting scientific trials in India for weight-loss capsule, orforglipron.
Biocon has not but filed for liraglutide approval in India and it’s working with the native drug regulators to see if the requirement of a scientific trials will be waived, Mittal mentioned. The corporate can also be searching for a associate to market its weight problems medicine in India after it offered its branded formulations enterprise to Eris Lifesciences Ltd. final month.
Over the subsequent 20 years, “it is a very enticing house”, Mittal mentioned. The UK approval exhibits that Biocon can confidently “seize the chance within the coming years.”
