Aurobindo Pharma says 14 biosimilar products under development

Aurobindo Pharma expanding specialty business, accelerating biosimilar development, and strengthening supply chain to boost growth in generics market.

Generic drugmaker Aurobindo Pharma is expanding specialty business, accelerating biosimilar product development as well as strengthening the supply chain and scaling operations in the growth markets to boost the business.

Fourteen biosimilar products are under different stages of development and in the U.S. it has submitted 14 peptide API drug master files (DMFs), the Hyderabad-headquartered firm said in a release on the strategic initiatives being pursued.

“We will continue to invest in research and development, line/capacity expansion related projects and capability enhancement projects, including biosimilars and biologics CMO. These investments will further drive our growth,” Vice-Chairman and Managing Director K. Nithyananda Reddy said.

The U.S. FDA, in an explainer for patients, on its website, said “biosimilar is a biologic medication. It is highly similar to a biologic medication already approved by FDA – the original biologic (also called the reference product). Biosimilars also have no clinically meaningful differences from the reference product.”

Biosimilars are made from the same types of sources, for example living cells or microorganisms and are just as safe and effective as their reference products, the U.S. FDA said.

Citing IQVIA MAT June 2024 data, Aurobindo Pharma said it is the largest generics player in the U.S. by prescriptions dispensed. The company has a manufacturing capacity of over 50 billion formulation units and 19,000 million tonne active pharmaceutical ingredients (APIs) with 29 manufacturing facilities in operations. Further, six facilities are under construction and expected to be operational in a couple of years.

Through subsidiary TheraNym Biologics, it had recently ventured into biologics contract manufacturing. Aurobindo Pharma had also announced signing of a master service agreement with MSD and plans to put-up a biologics manufacturing plant with a capacity of 25-30 million vials per annum at an investment of up to ₹1,000 crore.