Considering the expiration of patents of best selling biologics, greater regulatory support, scientific expertise, lower labour and goods costs, and smooth access to both domestic and regional markets, India has a tremendous potential to emerge a key player in manufacturing and marketing of biosimilars, the follow-on versions of biologic drugs, according to experts.
Patents for over six top selling biologics viz. Humira, Enbrel, Rituxan/MabThera, Avastin, Herceptin and Remicade will be expired between 2015 and 2020 allowing manufacturers of biosimilars to seek US FDA approval for generic biologics. More than 160 biosimilars have been reported in different stages of development for these six best selling biologics.
The “Guideline on Similar Biologics: Regulatory Requirements Marketing Authorization in India for Biosimilar Drugs” was released by the Department of Biotechnology and the Central Drugs Standard Control Organization to streamline the approval process and ensure high-quality biotech drugs. It will help Indian biosimilar industry attract more investment and reap benefit of biologics patent expiry.
Says Pushpa Vijayaraghavan, director at Hyderabad-based Sathguru Management Consultants, “Several large Indian companies have invested in biosimilars and have developed in-house product development capability. They are largely focused on India and rest of the world markets as initial targets but intend to aim for the developed markets in the future. Indian biosimilar segment has today built a foundation on which global success can be steered with appropriate commercial strategies and policy environment required to succeed in this capital intensive and time sensitive opportunity.”
The collaborations will be fundamental to Indian industry’s success in biosimilars. While Indian industry has now developed high level of technical capability, given the time sensitivity in biosimilars, asset level collaborations for technology access could accelerate time to market and global competitiveness, said Vijayaraghavan.
Compared to the US, the Indian regulatory bodies have been granting approval to Indian-manufactured generic biologics with reference products that have received approval in the US or Europe under an ad hoc abbreviated approval pathway for several years. There has been twenty biologics approved by India under this regime. There are several cases where the Indian regulatory authorities have approved these biologics based on phase 3 bioequivalence studies consisting of around 100 patients.
India’s biosimilar industry clocks growth at a compounded annual growth rate of 30 per cent. The domestic market is pegged at over $900 million. The country offers a better market to drug makers to exploit the over $1 billion global biosimilar industry in regulated markets.
Biosimilars having a therapeutic edge over generic drugs are difficult to copy than generic drugs because of the structure of the molecules. Biosimilars have a potential to fulfil India’s unmet healthcare needs. There are around 25 Indian life science companies operating in the biosimilar sector including Torrent Pharmaceutical, Zydus Cadila, Lupin, Cipla, Ranbaxy, Hetero Group, Dr Reddy’s and Biocon. Dr Reddy’s Laboratories was the first which launched the world’s first biosimilar antibody, Reditux.
Gautam Kothari, associate director of Equirus Capital said that biosimilars offer a high margin and USFDA stand on copies of biosimilars has provided Indian pharma tremendous opportunity. Talking about growth driver of biosimilar industry, he said “The key reason promoting the biosimilar growth is expiry of biologics’ patents worth $55 billion by 2020. The high cost of branded biologics, lower labour and goods costs, regulatory support and smooth access to both domestic and regional markets are some of the reasons behind the demand for biosimilars in emerging markets like India. Biosimilars are 25%-40% cheaper than branded originators”.
Biotech drugs can treat diseases like cardiac, diabetes and cancer. An increase in the number of tertiary healthcare centres across the country has been resulting in greater usage of biotech products.
A number of Indian companies are targeting monoclonal antibodies (MAbs) for their role in cancer therapy. A lion share of the market is expected from MAbs as well as for Enbrel, for treating inflammatory disease and insulin.