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India well positioned to capitalize on global biosimilars opportunity: Kiran Mazumdar Shaw
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Nandita Vijay, Bengaluru
December 28 , 2022
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Biosimilars can be the next success story for India and the country is well positioned to capitalize on this global opportunity, said Kiran Mazumdar-Shaw, executive chairperson, Biocon & Biocon Biologics.
India has over 125 approved biosimilars, making it the country with the largest number of approved biosimilars after Germany and the US as per Informa’s Pharma Intelligence Report 2021. The Indian biosimilar market was worth around $300 million in 2015 and is expected to reach $40 billion by 2030.
More than 50 Indian companies, including Biocon Biologics, Reliance Life Sciences, Zydus Cadila, Dr Reddy's Laboratories, Lupin, Intas, Wockhardt, Cipla, Glenmark, USV, Fresenius Kabi Oncology, etc., collectively have over 200 biosimilars in the pipeline.
With the medical paradigm shifting towards biosimilars, Indian companies must aspire to build their pipelines for global markets by investing in developing high-quality, world-class products and compete internationally, she added.
Further, the government’s backing is imperative in this endeavour of building global scale in biosimilars. A dedicated PLI (production linked incentive) scheme could incentivise such investments and additionally, research linked incentives will greatly augment capabilities to achieve competitive cost and speed to market against global players, noted Shaw.
Moreover, biologics represent the cutting-edge of biomedical research, and biosimilars present an enormous opportunity to provide affordable access to these advanced therapies. Biosimilars can bring in a transformational shift in the treatment paradigm of life-threatening conditions for patients worldwide, she said.
Over the next 5 years, biologic brands having revenues of more than $70 billion will lose exclusivity, presenting multiple new opportunities; a significant step up against $25 billion in the prior 5-year period. According to IQVIA, this has the potential to generate about $215 billion in cumulative savings for healthcare systems globally.
By focusing on providing affordable access to lifesaving biosimilars through technology innovation and economies of scale, India can emulate its global leadership in generic drugs and vaccines. Biosimilars have an important role in improving access to cutting-edge therapeutics across world markets. We are witnessing a perceptible increase in biosimilar adoption, due to greater clarity around scientific expectations in regulatory pathways. More recently, there has been strong penetration of biosimilars in the US with increased acceptance from patients, payers and prescribers, Shaw told Pharmabiz.
So far, Biocon has been leading India’s foray into the global biosimilars space and has made the nation immensely proud through its innovation-led business model that has led to six biosimilar molecules completing their ‘lab to market’ journey for developed markets. It has earned the distinction of being the only company from India to have commercialized three biosimilars in US and has been the first from India to have a biosimilar approved and commercialized in Japan since 2016.
In fact, Biocon Biologics recently concluded a strategic acquisition of Viatris’ global biosimilars business, transforming it into a fully integrated biosimilars company that is uniquely positioned to serve patients across the world. Apart from Biocon, there are several Indian pharmaceutical companies in the biosimilars space who are moving from domestic and developing markets to the advanced markets in Europe and US that are more demanding of large clinical data, she said.
Therefore we see biosimilars can play an important role in expanding the global market share of the Indian pharma sector in terms of value. With the right policies and incentives, this could be the next success story for the Indian pharma market after the impressive generics story, said Shaw.
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