About Author: Dr Cyrus Karkaria leads Lupin’s biotechnology division and is responsible for developing the company’s global biosimilars portfolio. With over three decades of experience at Celldex Therapeutics, CuraGen and Biogen, Cyrus has a proven track record in managing biologic drug development and commercialization of products across multiple markets, including the U.S. Cyrus is a post-doctorate from Harvard Medical School and a Ph.D. from the University of Maryland. He also holds a master’s degree in biochemistry from Mumbai University.
The Indian biopharmaceutical industry is one of the fastest growing globally and currently valued at US $60 billion. The country’s biosimilars market size was valued at US $349 million in 2022 and is estimated to expand at a CAGR of 25.2% from 2022 to 2030 to reach US $2.1 billion in 2030.
Our biopharma companies are already major outsourcing partners to global pharma companies. Industry can boast about its cost competitiveness, fast-growing manufacturing base, intellectual capital, strong marketing, and distribution network in domestic and international markets. These trends, combined with India’s huge population base, growing literacy and health awareness, increased purchasing power, growth in healthcare financing products and access to good quality medical care, will continue to propel the domestic Biopharmaceutical industry to new heights.
Trastuzumab biosimilar Ogivri, co-developed by Biocon and Mylan, became the first biosimilar from India to be approved in the US and the first Herceptin biosimilar globally. Neulasta, a pegfilgrastim biosimilar and India’s 2nd biosimilar followed suit.
Challenges before the industry
Despite the quick success and competitive advantages, India carries a mere 3% share of the global biosimilar market space. High investment costs in the development of biosimilars, added to their complex clinical and developmental requirements, dampen the zest of companies, disregarding the market demand and their therapeutic advantages.
The world-class manufacturing facility, global quality standards and understanding of the global IP and regulatory landscape are key ingredients for the global development of biosimilars. Indian biopharma companies have faced challenges in achieving market authorization in regulated/semi-regulated markets. The lack of defined guidelines for biosimilars in many emerging markets leads to tedious review processes, sometimes giving rise to unnecessary additional clinical studies, which is a cause of concern for the industry.
Indian Biopharmaceutical industry also needs a well-differentiated product portfolio and service offering to create a notable presence amongst US/EU regional players. Patient-friendly device development and digital platforms can help in this pursuit.
“Despite the quick success and competitive advantages, India carries a mere 3% share of the global biosimilar market space.”
In terms of the supply chain, most of the biopharmaceutical products need cold chain infrastructure to increase access and expand the biopharma market. Cost-competitive logistics and distribution networks need to be developed to improve the reach of Biosimilars to smaller towns and cities.
As part of the biosimilar development exercise, procurement of Innovator products in multiple batches and from various geographies has been a cost-intensive exercise. Harmonization of regulatory guidelines, though long discussed, has yet to be fully substantiated.
High turnaround timelines for biosimilars from conception to launch and Product life cycle management to battle innovator moves are some of the other challenges to overcome.
Key trends in India and Asia-Pacific
APAC, a pack of enticing opportunities for manufacturing biosimilars, is on an exciting journey, with markets projected to grow at 30 % each year. In the last decade, there was a massive shift from developing and manufacturing biosimilars from the West to the East, most evidently, in South Korea, going from 0% in 2012 to ~ 43 % today in the global biosimilars market by value. Japan is the 2nd highest investor in the research and development of biosimilars after the United States. India has been a long player in the generics market and has a highly advanced biosimilar pipeline.
Governments are acknowledging this opportunity to boost the economy and are accelerating this shift to the East. The Indian Government has been actively promoting biological drug development under the ‘Make in India’ initiative, BIRAC driven ‘National Bio-Pharma Mission, a collaborative initiative between DBT and the World Bank was initiated by the government.
Japan Biosimilar Association (JBSA) was established in Japan to address challenges in the development of biosimilars. Recent policy changes have also supported uptake in Japan; the new guidelines published by the Japanese Ministry of Health, Labor, and Welfare in April 2020 incentivise medical institutes to prescribe self-injecting biosimilars.
In China, the inclusion in the National Reimbursement Drug List of advanced biologic treatments in 2017 & 2019 has increased the uptake of biologics and will allow the market to expand further. Estimates suggest that about 400 separate biosimilars are in active development in China. The Chinese government launched the Marketing Authorization Holder (MAH) plan to allow drug license holders to sell in China using a contract manufacturer.
Oncology offers significant opportunities
For the last few years, activities in biosimilar development have been focused on the “big six” top-selling monoclonal antibodies worldwide: adalimumab (Humira), infliximab (Remicade), etanercept (Enbrel), rituximab (Rituxan/Mabthera), trastuzumab (Herceptin) and bevacizumab (Avastin). The latter three play a significant role in treating oncology patients and top the list of the best-selling oncology treatments. However, biosimilars are now available for all these biologic agents and have decreased treatment costs by bringing about price competition between the reference product and its biosimilar competitors.
Future biosimilar opportunities will likely focus on the next wave of oncology products. Top cancer drugs predicted in the Oncology space include Opdivo, Keytruda, Tecentriq, Darzalex, Perjeta and Gazyva, with projected USD 5-10 B+ sales revenue. Second-tier molecules with predicted revenues of 800M to 2.5B USD include Yervoy (ipilimumab), Xgeva (denosumab), or Kadcyla (trastuzumab-emtansine).
“Companies seeking to be first to market with a biosimilar must also accelerate their drug development.”