Lupin is building a discovery pipeline with over seven to eight molecules targeting the oncology and inflammation segments. The company, producing both branded and generic drugs, is also planning an investment of $20 million to expand and build additional facilities and capacities exclusively for biologics in Pune in next two to three years.
?We have over seven to eight molecules in the pipeline. Of these, three are already undergoing clinical trials, while two are in pre-clinical stage. One more molecule will be entering pre-clinical stage soon,? Cyrus Karkaria, Lupin president said, adding that the company was gearing up to launch a new product this year. He also indicated that some of these lead molecules could be potential out-licensing targets at some point of time.
Biosimilar products include recombinant erythropoietin, recombinant granulocyte colony stimulating factor (G-CSF), interferon alpha and beta, human insulin, monoclonal antibodies and human growth hormone. These are used oncology, infectious diseases, chronic autoimmune diseases, growth-related deficiencies and haematology.
As part of its expansion, Lupin will be expanding facilities in Pune, which will be operational in next two to three years. ?We currently have a production facility near the lab. We will be building additional facilities with about $20 million investment in next two to three years,? Cyrus explained. Last year, the company announced plans to invest over R450 crore towards capacity expansion and strengthening sales force. Lupin is also gearing up to launch its first biosimilar product in India by early next year besides targeting 5-7% of its business from biosimilar business.
The company had entered into a licensing agreement with Sydney-based NeuClone for cell-line technology which will provide exclusive proprietary cell-line technology to be developed into biosimilar drugs targeting cancer.
Several drug companies, including Dr Reddy?s, Cipla and Biocon, among others, are eying the opportunity in biosimilars. Industry estimates global market for biosimilars or follow-on biologic drugs is about $100 billion and the Indian market is about R2,500 crore.
Meanwhile, the US Food and Drug Administration has issued three guidances on biosimilar product development to assist industry in developing such products in the US. These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.