Biopharmaceuticals accounted for nearly 25 percent of the global pharmaceutical market revenues from marketed drugs (~USD 1100 billion) in 2016. To add to this, the patent expiry of the leading 10 biologic drugs represents a massive USD 70 billion opportunity for pharma companies over the period 2015-2020. Against this backdrop, Indian generic pharma players will have to explore mergers and acquisitions (M&As) and alliances to enter new markets and grab a major share in the global biosimilar market, says leading data and analytics company GlobalData. India is the world’s largest supplier of generic drugs. Biopharmaceuticals, which include vaccines, therapeutics and diagnostics, was the largest sub-sector of the Indian biotechnology industry and accounted for approximately 65 percent of the total revenues in 2015. There are already more than 70 biosimilar products approved in India. According to GlobalData, the Indian biosimilar market is expected to increase from nearly USD 250 million in 2016 to more than USD 1 billion by 2020.
Some of the notable Indian companies that have been quick to get off the block are Dr. Reddy’s Laboratories (DRL), Glenmark, Biocon and Lupin among others. Indian companies are actively pursuing M&As and marketing tie-ups to gain a foothold in the biosimilar space. A pertinent example of a successful tie-up is that of Biocon and Mylan. The FDA approval for their biosimilar drug trastuzumab (Ogivril) marks a first for any Indian tie-up. Biocon, in partnership with Mylan, has also received approvals from the European Commission and TGA, Australia for the biosimilar Insulin Glargine—Semglee, and FDA approval for pegfilgrastim (Fulphila), a biosimilar to Amgen’s Neulasta. These approvals are expected to unlock an estimated $1bn opportunity for Biocon. Biocon has entered into a partnership with Sandoz to jointly develop and market biosimilars. With other biosimilars like adalimumab, bevacizumab and etanercept in pipeline, Biocon is nicely placed to reap the biosimilar windfall.
Lupin is now reporting significant progress with respect to its biosimilar portfolio after nine years of hard work and investment. Earlier this year, it applied with the European Medicines Agency for etanercept approval and plans to apply for approval in other major markets as well. The company forged sales and distribution agreement with Nichi-Iko for etanercept in Japan and has partnered with Mylan to market it in Europe, Australia, New Zealand and Asia. However, the biosimilars market is a challenging market to traverse. Entry into the biosimilars market involves significant investments in terms of R&D, manufacturing and marketing set-up and longer time to market. Vikas Bedi, Head of APAC Healthcare Research at GlobalData, says: “Although Indian companies have been very successful in the generic market, a serious effort for biosimilars has been forthcoming from only a few, as quality standards continue to be an issue with them.”
Biocon had to withdraw its marketing approval applications for two anti-cancer drugs in Europe in 2017 as regulatory authorities sought re-inspection of its manufacturing facilities. Cipla feels that an in-house effort on biosimilars is quite demanding in terms of resources, time and investment and is likely to impact their focus on respiratory and specialty pharmaceuticals. Bedi adds: “Indian pharma industry is not actually known for its innovation and specialty orientation. As a result, the road to success for Indian pharma companies demands a significant change in vision, approach and application.” The traditional strengths of India in terms of infrastructure, low cost skilled workforce, the current biosimilar pipelines, fresh investments and M&As and alliances will help Indian companies to cement their place in the biosimilar market. However, they need to raise manufacturing quality standards to global levels and reduce dependence on the US market.
Bedi concludes: “Marketing tie-ups can provide access to new technology, products and markets, and reduce the investment in terms of time, money and effort. The Government of India, on its part, has to come up with a transparent regulatory framework and a market friendly policy to allow Indian companies to evolve and transition to take advantage of the ‘biosimilarization’ wave that is already gathering momentum.” – Medical Buyer Bureau