The Lupin Biotechnology Research Group was established 5 years ago with a vision to provide affordable, high quality biopharmaceuticals with a focus on biosimilars. In a short span of 5 years, Lupin Biotech scientists have created and developed a basket of 10 biosimilars, which are now in various stages of development. 8 of these are potential blockbusters addressing diverse and niche therapeutic indications like Oncology, Inflammation, Antivirals, Osteoporosis and Rheumatoid arthritis.
Highlights, FY 2013
- Lupin Biotech received marketing authorisation for its first oncology product following the successful completion of its multi-centric, Phase III Clinical Trial in India
- Another long-acting oncology product is close to receiving marketing authorisation and has demonstrated excellent biosimilarity in Phase III Clinical Trials in India
- 5 biosimilar products, including a basket of Blockbuster Monoclonal Antibodies and therapeutic Recombinant Proteins are in advanced stages of development, having successfully completed pre-clinical studies
- 3 process patents have been filed for 2 of these products
The product development process adopted in Lupin's biosimilar products conforms to ICH and biosimilar guidelines issued by the Indian regulatory bodies and also in keeping with global regulatory requirements. The products have been designed with proprietary expression systems, innovative processes and novel formulations, encompassing 15 patents filed and 23 publications so far. Novel formulations have been successfully developed for three of the products, thus providing a competitive advantage. Lupin Biotech team's efforts position the Company well in the lucrative but challenging global Biosimilars space.