Dr Reddy’s to work ‘closely’ with USFDA on biosimilar rituximab to launch it in US

Hyderabad Pharma major Dr Reddy’s Laboratories will work together with the US Food and Drug Regulator (USFDA), according to its top leadership.

“Our dossier for the proposed rituximab biosimilar candidate received a Complete Response Letter from the USFDA. We will continue to work closely with the USFDA to address and resolve all concerns within stipulated timelines in order to make this biosimilar rituximab available to patients in the U.S. as soon as possible,’‘ Dr Reddy’s Chairman K Satish Reddy and Co-chairman and Managing Director G V Prasad said in their message to the shareholders in the Annual Report for the year 2023-24.

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As part of the usual course of business, the Hyderabad-based company faced several regulatory inspections at its manufacturing sites in FY2024. they said, adding, “Our all-time readiness approach stood us in good stead but we continue our state of constant vigilance in Quality compliance.’‘

Overall, Dr Reddy’s delivered strong. financial results in FY2024. “We had double digit revenue growth at 14 per cent, reported EBITDA margin for the year at 29.7 per cent, and ROCE of over 35 per cent. Our growth and profitability were driven by our performance in the U.S. Strategic collaborations played an important role in helping us introduce the latest generation of treatments to patients in India, both in our current core business as well as future growth drivers,’‘ they said. 

MILESTONE

The company marked its 40th year of serving patients with a legacy of access, affordability, innovation, and sustainability in February 2024. The company was founded in 1984 to enable patients to access life-saving medicines, and to use science and innovation to open new avenues to meet unmet medical needs. 

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“This pioneering spirit and quest for excellence drove us to achieve significant industry-firsts such as investment in drug discovery in the 1990s, expansion into international markets and first-to-market launches in several countries, the first 180-day exclusivity granted to Indian pharma by the USFDA, listing on the NYSE, and adoption of voluntary disclosures and science-based commitments in sustainability,’‘ Reddy and Prasad said. 

For the leadership duo, there is still a long way to go for the drug-maker. “No company can afford to rest on its past laurels. The pharma landscape continues to evolve constantly and remains extremely competitive. Our approach is to ensure that we continue to do the basics well in our core businesses of API, generics, branded generics, biosimilars and OTC,’‘ they said.

On the other hand, as demographics, disease patterns, business models evolve, it is important to anticipate healthcare trends of the future. The company started investing in areas that it thinks could be future growth drivers – novel molecules (NCEs, NBEs, CAR-T), digital therapeutics (wearables, apps), and consumer healthcare (nutrition and OTC wellness). 

”These are relatively new and long-gestation areas requiring companies to think and do things differently through strong partnerships, investment in newer capabilities, and an appetite for risk. In FY2024, we made good progress in some of these areas,’‘ the message said.