Weight loss products, including semaglutide, will be a key driver of growth for Indian pharma major Biocon, top executives of the company said.
“Our GLP (glucagon-like peptide) portfolio, including Liraglutide, Semaglutide and Tazepetide, is expected to play a major role in the mid to longer-term. We see GLPs as the major growth driver of the business, from fiscal 2026 onwards,” said Peter Bains, Group CEO of Biocon. “Market data here indicate the market opportunity of GLP's to reach nearly $100 million by the end of this decade, and we have a comprehensive pipeline to address and compete in this major strategic market opportunity,” he added in the investor presentation after the Q4 results.
In March, Biocon, through its European partner, Zentiva, had received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA), UK, for its complex formulation Liraglutide (gSaxenda) injection, used in the treatment of weight management as an adjunct to a reduced-calorie diet and increased physical activity.
In April, Biocon had entered into an exclusive licensing and supply agreement with Biomm SA, a specialty pharmaceutical company in Brazil, for the commercialisation of Semaglutide (gOzempic), a drug product used to improve glycemic control in adults with type-2 diabetes.
Weight loss products have driven revenues in recent years for global giants like Novo Nordisk and Eli Lilly through their products like Ozempic, Wegovy, Mounjaro, Zepbound etc. This helped Novo Nordisk to become Europe’s most valuable company in September 2023.
Biocon released its January-March quarter results for fiscal 2023-24 (Q4FY24) on May 16, reporting a decline of 57 per cent in consolidated net profit at Rs 135.5 crore, compared to Rs 313.2 crore in the corresponding period last year. The pharma major's revenue from operations in the fourth quarter of FY24 stood at Rs 3,917 crore, registering a rise of four per cent, compared to Rs 3,774 crore in the year-ago period.
Regarding regulatory inspections at its plants, the company said that it has implemented corrective action suggested by the US regulator. Eli Lilly has floated plans to enter the Indian market soon.
“Turning to our Malaysia site, we have completed the implementation of all the corrective and preventative action as per the committed timelines and have provided the US FDA with a comprehensive update,” Bains said.
“As a next step, we are now anticipating the agency to visit and to inspect both the Bengaluru and Malaysia sites which, subject to outcome, would pave the way for approval of our biosimilar Aspart from Malaysia site and our biosimilar Bevacizumab from our Indian site,” he added.
Insulin Aspart is a rapid-acting, human insulin analog that is FDA approved for the treatment of type-1 and type-2 diabetes mellitus to improve glycemic control in adults and children. Bevacizumab injection products are used in combination with other chemotherapy medications to treat certain types of colon and rectal cancer, non-small cell lung cancer, glioblastoma, renal cell cancer, cervical cancer and ovarian fallopian tube or peritoneal cancer.
A biosimilar is a biological medicine highly similar to another biological medicine already approved in terms of structure, biological activity and efficacy, safety and immunogenicity profile.
The Malaysian plant was last inspected in October 2023 and was classified as Official Action Indicated by the US FDA. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.
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