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The market growth of biosimilars in the US and Europe has undoubtedly motivated Indian biopharmaceutical companies like Reliance Life Sciences, Biocon to be at the forefront of biosimilar development and commercialization. The Indian market saw its first biosimilar approved in the year 2000 for hepatitis B. According to CDSCO, biosimilar approvals have increased significantly to 98 until September 2019. However, ongoing challenges prevail in order to deliver the dynamics and uniqueness of biosimilars with strategic plans in place for development that are integrated with commercial plans to develop biosimilars.
The biosimilar Indian market is expected to grow from $300 million in 2015 to US $60 billion in 2030. The Indian biopharmaceutical market is growing at 15 per cent annually, twice the world market growth rate, which has led to enormous potential to develop and commercialise biosimilars. The government of India is supporting the pharma and biopharma companies to enhance their infrastructure and invest in the biosimilar expertise requirements so that the nation can grasp a share of 8 to 10 per cent in the biopharmaceutical manufacturing space. Even in academics, the government supports translational research through various research funds that are released to various national research labs and universities as they too play a key role in the development of biosimilars. Biosimilars from India that are exported to highly regulated or emerging markets represent around US $51 million. Mylan Pharmaceuticals launched Trastuzumab, the world's first biosimilar in India that was approved by the US FDA.
In the coming years, approximately ten biologic blockbusters will be released from patent, creating enormous opportunities for Indian manufacturers of biosimilars to make the product more cost-effective. For example, in the year 2021, Genentech/Roche’s Ranibizumab went off patent in the US. As per the Informa Pharma Intelligence report, Regeneron Pharmaceuticals’ Aflibercept will go off patent in the US in 2023. Many biologics like Levemir, Avastin, and Humira are set to go off patent and many Indian manufacturing companies can grab these opportunities to increase their global market share. Due to the Covid-19 pandemic, a lot of clinical research activities have been hampered. Hence, focusing on strengthening the contract research and development capabilities and their related activities may enhance the market approvals and speed up the relevant data compilation in these emerging markets.
The global regulatory environment for pharmacy is becoming more stringent and, in order to compete in the global market, the Indian pharmaceutical industry requires a strong regulatory framework. However, the pharmaceutical industry is currently dealing with a number of issues, including clinical trial approval delays, a new pharmaceutical pricing policy, a uniform code for sales and marketing practices, compulsory licensing, manufacturing quality, regularity uncertainty, prescribing reluctance, manufacturing complexities, and competition, all of which require immediate attention.
The complexity of the bioprocesses, the need for advanced infrastructure, qualified experience, and the development of manufacturing technologies are among the major obstacles that biosimilar producers must overcome in order to produce their products affordably. National funding organisations like the Biotechnology Industry Research Assistance Council (BIRAC) under DBT have consistently worked to bridge the aforementioned gaps in India's capacity and aptitude over the past six years by supporting crucial infrastructural projects all around the nation. High capital expenditure (CAPEX) and operational expenditure (OPEX) capacity necessary for constructing end-to-end biopharmaceutical research facilities have received financial assistance in the form of grants. Through the building of high-end capacities (such as cell line repositories and process development), startups, academia, and Micro, Small, and Medium-sized Enterprises (MSMEs) have also been assisted. A streamlined regulatory process and increased regulatory convergence with approved agreements on mutual recognition with the WHO and ICH. Concentrating on the assessment of regulatory readiness for complex biosimilars and dealing with complicated concerns like interchangeability. Concentrating on influencing perceptions of Indian biosimilars' quality in the world by making stakeholders more visible in international fora with deeper consideration of subject matter experts in decision-making for long-term technological investments and regulatory policy changes. Small- and medium-sized businesses can operate more efficiently and affordably by setting up infrastructure for new technology development and analytical platforms for imported processes and consumables.
The need of providing appropriate training on both new and existing technology cannot be overstated. In order for the innovation that started in academia to grow into cost-effective commercial processes, structured interactions between academics and industry are essential. It is necessary to make provisions for the effective and efficient use of the resources that are readily available locally in research. As a cost-analyzing and design technique, the effective use of mathematical models that may take a range of aspects into account is necessary. The model should take into account a multitude of issues relating to private participants, laws, and regulations.
There is a need to motivate pharmaceutical companies to set innovative commercial models for biosimilar development and commercialization. The key aspects that lead to enhancing the commercialization of biosimilars in India can be discussed as below:
Dynamic regulatory support
In India, the Central Drug Standard Control Organization and Drugs Controller of India support biopharmaceutical companies to review the regulatory requirements for biosimilars. The mechanism to incentivize the investments and build up the confidence level among the scientists will help the nation achieve greater traction in the global market.
Market access
Over the last few decades, the Indian market has observed price sensitivity and market access limits with biosimilars. Nevertheless, currently India has shown potential in latest technology being adopted for supply cold chain logistics and improved the market access. We have also seen an increase in affordability; biosimilars are available at a low price, and this would support their uptake across the nation.
Technology
Government initiatives like the National Biopharma Mission and the Atal Incubation programmes have significantly changed the market scenario for biosimilars. The biosimilars market in India is estimated to grow at a compounded annual growth rate (CAGR) of 22 per cent to become US$ 12 billion by 2025. This would represent almost 20 per cent of the total pharmaceutical market in India.
Portfolio management
Identification of the right biologics or biosimilars to treat the next generation of autoimmune disorders, understanding the availability of patient pool with high prevailing incidences of diseases like cancer, diabetes, and rheumatoid arthritis are a few factors that need to be considered.
Clinical trials
India has a great opportunity to position clinical trials focused on biosimilars, as we already have 5 per cent of the world's active/planned trials in our country.
Biosimilar market players will need to implement a long-term strategy to provide reasonably priced products with improved access to patients in remote areas. Impacting the local population, identifying the therapeutic areas, manufacturing scale up and also leveraging the importance of building consumer engagement and branding in successful ways will help India to be a world leader in biosimilars.
(Author is associate professor, Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management, NMIMS)
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