Our Biologics business is developing into a global player in biosimilars
Our endeavour is to improve access to biosimilar products globally through a combination of collaborations and clinical research. Having launched multiple biosimilar products in India and other emerging markets, we have also taken this business into highly regulated markets. Over the last 25 years, our biosimilars business has developed into a fully integrated organisation, with capabilities across development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have built a balanced and diversified portfolio, with the aim to be first-to-market in highly regulated markets.
Facilities
Our Biologics teams are based across Hyderabad (India), Basel (Switzerland), and New Jersey (USA). Our cGMP manufacturing facility in Hyderabad is WHO-approved and audited by several regulatory agencies. The facility has on-site integration of drug substance (DS) and drug product (DP) manufacturing. This approach gives us the advantage of cost optimisation and we have a history of successful DS and DP technology transfers.
Overall, a manufacturing capacity of more than 14,000 litres and multiple reactors of 1,000 litres allow us to support varied manufacturing needs. We also have the capability to manufacture viral vaccines and viral vectors used for a variety of therapeutic applications.
Research & Development
The vertically integrated R&D team has top-class professionals with diverse capabilities, from in-house cell line development to clinical development. We have extensive development experience across a variety of biological products including monoclonal antibodies, glycosylated and PEGylated proteins and fusion receptors, with the capacity to develop non-infringing high concentration proprietary formulations. We have the ability to run complex global biosimilar studies, to meet the requirements of regulatory agencies across the world, including U.S. Food and Drug Administration (US FDA) and European Medicines Agency (EMA).
Our Products
Patients across the world have been treated with our oncology and immunology biologics products. Our biosimilar business is an important strategic initiative and will drive both near-term and future growth. In 2007, we launched the world’s then first biosimilar rituximab in India under the brand name Reditux.
Our current portfolio comprises six commercial products marketed in India, with some products marketed in more than 25 other countries. One of our products, Pegfilgrastim, has been commercialised in the U.S. and in Europe through our partner. In addition, we have a pipeline of products in oncology and auto-immune diseases, in various stages of development for global launches, including a biosimilar Abatacept candidate as well as a biosimilar Rituximab candidate. We are also ramping up manufacturing capacity to support our global expansion plans.
In December 2021, we entered into a binding agreement for an exclusive partnership for the supply and commercialization of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia. Our partnership with Prestige BioPharma helps us combine their established expertise in the area of biosimilars with our commercial strengths and growth ambition by expanding our biosimilar offerings in Emerging Markets.
In December 2022, we announced that the successful completion of the phase 1 study of DRL_TC, a proposed biosimilar of tocilizumab. Our tocilizumab biosimilar candidate, DRL_TC, successfully met its primary and secondary endpoints in its Phase 1 study. This Phase 1 study used a subcutaneous formulation to evaluate the pharmacokinetic equivalence, safety and immunogenicity of our tocilizumab biosimilar candidate in comparison to reference products. In June 2023, we announced the successful completion of the Phase 1 study DRL_TC via the intravenous route.
In July 2023, our proposed rituximab biosimilar application was accepted for review by USFDA (United States), EMA (Europe) and MHRA (United Kingdom). In January 2023, we had announced the successful completion of the full set of clinical studies of our proposed rituximab biosimilar candidate, DRL_RI, for filing in highly regulated markets.
In March 2024, we launched Versavo® (bevacizumab) in the UK. Versavo® (bevacizumab) is indicated for the treatment of several types of cancers including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer.
We have spent the last two decades investing in building tools, understanding the science of complex proteins, intra-cellular metabolism and pathways, modulating mechanics of cell production, and understanding elements of structure and function that makes a difference in clinical use. We have experienced first-hand the impact that high-quality biosimilars can make to patients worldwide. We are strongly driven by our purpose of accelerating access by making complex life-saving biosimilar products affordable to patients across the globe because Good Health Can’t Wait.
