With an eye on India's biosimilar market which is estimated to grow to US$ 5 billion by 2022, Epygen Biotech, an international biotechnology group headquartered at the Dubai Science Park, is coming up with a manufacturing plant at Patalganga in Raigad MIDC belt, Maharashtra with five biosimilars in pipeline.

Spread over 60,000 square feet, the manufacturing facility will be operational by the end of 2018 and will commercialize five biosimilars which are being developed at our own technology incubation center at Navi Mumbai in Maharashtra. Besides India, we also have laboratories and facilities in USA and Dubai. Around Rs. 175 crore have been earmarked by the company for research and development of five biosimilar drugs which will be launched by 2022, said Debayan Ghosh, founder & president, Epygen Biotech.

Currently, the preclinical trials are happening based on Patalganga plant and CTs are lined up. The first biosimilar drug, recombinant streptokinase (rSK) will be launched by the company in the country by early 2019 to treat cardiovasular disease. We have licensed this new version of the Thrombolytic protein (rSK) technology from CSIR, government of India, which will be commercialised by next year, he said.

The market of this stepping stone product is estimated to be Rs. 100 crore. Around 17 lakh people die of heart attack in India every year. Many of them cannot afford expensive treatment options like TPA or Cath lab. They can benefit from our biosimilar drug, recombinant streptokinase which will be cheaper than existing treatment procedures, he added.

Epygen's other pipeline products are Pegfilgrastim which is meant for the prevention of chemotherapy-induced neutropenia among cancer patients. Another E.coli based postmenopausal osteoporosis recombinant protein called Teriparatide is also in pipeline. Besides this, there are a couple of oncology biosimilars in the pipeline such as monoclonal antibody for metastatic colorectal cancer. This mAb will be harvested from a Chinese hamster ovary (CHO) cell.

Over next five years, we will launch all the molecules which are currently under pipeline. By 2022 global biosimilar market will cross USD 60 billion mark. India has 20 per cent of world's population but it produces just one per cent of world's biologics. By 2022, Indian bio-pharmaceutical space will go up to US$ 5 billion from existing less than US$1 billion. To capitalize on growing biosimilar market in India and the region, Epygen is foraying into the country with a robust pipeline of biosimilar drugs. Biological drugs offer effective treatment for a slew of critical ailments-- oncology, rheumatoid arthritis (RA), diabetes etc. We need to make sure that treatment of the critical ailments reaches the larger population where governments can play a key role, said Ghosh.

The growth of biosimilars could substantially cut health-care costs in India. Indian regulatory system is also evolving to streamline the biosimilar regulation at par with global regulations such as EMA which will create enabling environment for growth of bio-pharma industry.

While the Indian market holds great promise for biosimilars, the country lacks eco-system for biopharmaceutical industry. The eco-system has to be extrapolated to the regions other than Bangalore and Hyderabad to make the country hub of biosimilar manufacturing, he opined.

Talking about cost effectiveness of biosimilar drugs, he said that cost of innovator drug Herceptin of Roche used for breast cancer hovers around Rs. 65,000 a vial. The price of Mylan-Biocon’s trastuzumab, herceptin biosimilar is comparatively much lesser. In Europe, biosimilars have led to 60 per cent price erosion of biologics. In future, biosimilar drugs will rule the market. Therapeutic segments-- oncology, immune disorder-- arthritis, psoriasis, and diabetes will witness a significant growth of biosimilar drugs in coming years.

Besides India, Epygen is also planning to launch products in the RoW (Rest of the World) market which is an exciting assortment of more than 35 different markets entailing South East Asia, Asia Pacific, Africa & Middle East. This is 10% of the world's biosimilar market. It increases our market potential by 10 folds, he concluded.