Aurobindo Pharma To Expand Biosimilar Range With 14 Upcoming Products

Aurobindo Pharma, known for its generic drugs, is broadening its specialty business by fast-tracking the development of biosimilar products, enhancing its supply chain, and expanding operations in emerging markets to drive growth. The Hyderabad-based company is advancing 14 biosimilar products through various stages of development and has filed 14 peptide API drug master files (DMFs) with the U.S. regulatory authorities, according to a recent update on its strategic efforts.

Vice-Chairman and Managing Director K. Nithyananda Reddy said in a statement, “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.”

The U.S. FDA, in an explainer for patients, on its website, mentioned “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.”

According to the U.S. FDA, biosimilars, derived from the same types of sources like living cells or microorganisms, offer safety and efficacy comparable to their reference products. Aurobindo Pharma, based on IQVIA MAT June 2024 data, is the leading generics provider in the U.S. in terms of prescriptions filled. The company boasts a manufacturing capacity exceeding 50 billion formulation units and 19,000 metric tons of active pharmaceutical ingredients (APIs), supported by 29 operational manufacturing facilities.

Additionally, Aurobindo Pharma has six more facilities in the works, slated to become operational within a few years. The company, through its subsidiary TheraNym Biologics, has recently entered the biologics contract manufacturing sector. Moreover, Aurobindo Pharma has announced a master service agreement with MSD and plans to build a biologics manufacturing plant with a capacity of 25-30 million vials per year, involving an investment of up to ₹1,000 crore.