Biologics To Push Indian Pharma Growth

The Covid-19 pandemic has exposed the global inequity in access to essential medicines such as vaccines, particularly when combating infectious diseases. This inequity extends to non-communicable diseases (NCDs) such as diabetes and autoimmune diseases as well. Pandemic related delays, disruptions in diagnoses and treatment of NCDs have further impacted access.

Biologics are an effective treatment option to combat this twin threat of infectious diseases and NCDs. However, while there are many biologic therapies available globally to treat a host of chronic and infectious diseases, these therapies are often very expensive and unaffordable for many patients in both developed and emerging economies. What puts them out of reach for many is not just the high development but also high manufacturing costs that pharma companies have to bear to manufacture these complex biopharmaceuticals. 

Biosimilars are high-quality, affordable versions of originator biologics and can address this affordability challenge. Biosimilars can enable greater patient access to life-saving treatment and provide a viable path to improving health equity and reducing the cost burden to healthcare systems globally. In fact, the inclusion of biosimilars in health policies is estimated to lead to cumulative savings of USD 215 billion globally between 2021 and 2025. With originator biologics worth over US$ 70 billion scheduled to lose patent exclusivity over the next five years, biosimilars present a large and important opportunity for the global pharma industry in general and India in particular. 

Is India ready to ride this wave?

Biocon Biologics: Expanding Access to Biosimilars Worldwide

India has been an early mover in the development and commercialisation of biologics. It led the world in biosimilar innovation and access by becoming the first country to approve a biosimilar (a hepatitis B vaccine), in 2000, whereas biosimilars received their first approval in the EU in 2006 and the US much later in 2015.

Today, Biocon Biologics is leading India’s efforts to enable affordable access to expensive biologics for millions of patients both at home and globally. In addition to several ‘firsts’ to its credit, such as being the first company globally to secure FDA approval for biosimilar pegfilgrastim and trastuzumab (both oncology biosimilars), Biocon Biologics is the only company from India to have seven biosimilars commercialised in global markets, including three in the US and five in Europe.  Biocon Biologics is also the first company globally to receive interchangeability designation for its long-acting insulin glargine biosimilar from the USFDA, one of the largest producers of biosimilars in Asia and among the top three producers of biosimilar insulins globally.

Biocon Biologics has a diverse portfolio straddling monoclonal antibodies for cancer and autoimmune diseases, as well as rh-insulin and insulin analogs for diabetes. With a diverse portfolio and large-scale manufacturing capacities to meet patients’ needs across the world, Biocon Biologics has served over 5.3 million patients globally in FY22. The company started investing in building R&D capabilities and global scale early on and has made over USD 1 billion of investments in R&D and manufacturing. Biocon Biologics continues to invest up to 15 per cent of its revenue in R&D to develop a strong portfolio of high-quality, affordable biosimilars. 

Today we are seeing quite a few Indian pharma companies developing biosimilar products for patients in India, but very few of them are developing these products for global markets such as the US and Europe. This is because large investments in both R&D and bio-manufacturing capabilities and scale are required to meet stringent international regulatory guidelines in developed markets. The cost of developing a biosimilar product can be in the region of USD 100-150 million compared to USD 1-5 million for small molecule generics, an area the Indian pharma industry has dominated thus far. 

Given the large opportunity biosimilars present, Indian companies should consider investing in both R&D and global scale manufacturing capabilities to develop biosimilars for global markets. By doing so, Indian companies have the potential to replicate its global generics success story. 

Government Push Needed for Biosimilars Industry

The government needs to set up the right policy framework and incentives to create an enabling ecosystem that encourages Indian pharma companies to take up the challenge of making India a leading provider of affordable biologics to patients across the world. The Indian biopharma industry needs to focus on upscaling and enhancing its capabilities by investing more in R&D, quality, analytical, clinical and engineering expertise.

The production-linked incentives scheme is a step in the right direction and can provide a fillip to pharma investment in the country. Going forward, research-linked incentives can create the much-needed stimulus for the biopharma industry to invest in cutting-edge research in novel biologics and biosimilars.  

Indian Pharma Needs to Move Up the Value Chain

Biosimilars offer an attractive opportunity for India to move up the value chain and build global leadership. Given the fact that the global biosimilars market is projected to grow to USD 450 billion by 2047 from USD 100 billion in 2030, Indian companies could potentially realise sales of US$ 90 billion in 2047 by capturing 20 per cent of the global biosimilars market. 

India’s pharmaceutical industry is at the global forefront as ‘The Pharmacy of the World.’ With the right policies and incentives in place, biosimilars could be the next success story for the Indian pharma industry after generics.