Aurobindo Pharma, a prominent player in the generic pharmaceutical industry, is significantly broadening its specialty sector by focusing on the accelerated development of biosimilar products, enhancing its supply chain, and scaling operations in high-growth markets. This strategic move is aimed at propelling the company’s business forward.
Currently, Aurobindo Pharma is advancing the development of fourteen biosimilar products at various stages. In the United States, the company has submitted fourteen drug master files (DMFs) for peptide active pharmaceutical ingredients (APIs). This submission marks a crucial step in the company’s push into the biosimilars market, reflecting its commitment to expanding its product offerings in this sector.
The company’s Vice-Chairman and Managing Director, K. Nithyananda Reddy, emphasized the firm’s dedication to investing in research and development, as well as projects related to increasing production capacity and enhancing capabilities. These efforts include a particular focus on biosimilars and contract manufacturing for biologics. Reddy highlighted that these investments are expected to drive future growth for Aurobindo Pharma.
According to the U.S. Food and Drug Administration (FDA), biosimilars are biologic medications that are highly similar to an already approved biologic medication, known as the reference product. The FDA explains that biosimilars exhibit no clinically meaningful differences from their reference counterparts. These medications are produced using similar sources, such as living cells or microorganisms, and are deemed equally safe and effective as the original biologics.
In addition to its biosimilar initiatives, Aurobindo Pharma has emerged as the leading generic drug provider in the United States based on prescriptions dispensed, as per data from IQVIA MAT June 2024. The company boasts a substantial manufacturing capability, with over 50 billion formulation units and 19,000 metric tons of active pharmaceutical ingredients (APIs) across 29 operational manufacturing facilities.
Furthermore, it is constructing six additional facilities, which are anticipated to become operational within the next couple of years. Aurobindo Pharma is also expanding its presence in the biologics sector through its subsidiary, TheraNym Biologics. Recently, the company announced a master service agreement with MSD and plans to establish a new biologics manufacturing plant. This facility will have the capacity to produce between 25 to 30 million vials annually, with an estimated investment of up to ₹1,000 crore.
Overall, Aurobindo Pharma’s strategic initiatives underscore its commitment to driving growth through diversification and innovation in the pharmaceutical industry, particularly in the areas of biosimilars and biologics, while continuing to strengthen its manufacturing and operational capabilities.
Aurobindo Pharma, headquartered in Hyderabad, is a leading global pharmaceutical company specializing in generic and specialty medicines. It focuses on biosimilars, biologics, and robust manufacturing capabilities, with over 50 billion formulation units and a significant presence in the U.S. market. The company is committed to advancing healthcare through innovation and strategic investments in research and development.