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 dropping 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 way 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 group and group is making certain that we don’t hand over the lead place we’ve now,” Chief Government Officer Siddharth Mittal stated in an interview.
One other 15 peptide formulations are underneath improvement, of which one or two medication will search regulatory approval this 12 months, he stated. 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 medication 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 growing their anti-obesity medication.
Weight reduction medication have already produced report revenue for progressive pharmaceutical corporations from Novo Nordisk to Eli Lilly & Co. The gold rush is ready to unfold to generic makers like India’s greatest gamers when patents expire within the coming years on Ozempic and Wegovy, permitting cheaper copies of the medicine 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 referred to as glucagon-like peptide 1, or GLP-1, agonists.
Biocon is constructing functionality “to reap the benefits of what could possibly be a really, very strategic peptide alternative with GLPs on the middle,” Group Chief Government Officer Peter Bains advised analysts in November.
‘Very Complementary’
The lack of exclusivity for GLPs will create a multibillion greenback market over the following 10 years and this chance was “very complementary” to Biocon’s present biologics enterprise, based on Bains.
Within the UK, Mittal stated the corporate will look forward to the publicly-funded, Nationwide Well being Companies, to drift a young to launch its liraglutide injectible. Biocon’s UK software was filed by its European associate, Zentiva SA. The overall addressable UK market alternative for GLP-1 in diabetes and weight reduction is $425 million, based on a March 27 assertion by Biocon.
Regardless of the weight-loss phase being a rage globally, these medication 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 stated. The corporate can also be on the lookout for a associate to market its weight problems medication in India after it offered its branded formulations enterprise to Eris Lifesciences Ltd. final month.
Over the following 20 years, “it is a very engaging area”, Mittal stated. The UK approval exhibits that Biocon can confidently “seize the chance within the coming years.”
