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The Need for Growth in Indian Biosimilars

By responding strongly to a soaring demand for generic drugs, India’s pharmaceutical producers emerged as world market leaders in this sector and were a major business success story in the 2000s. In the process, Indian producers made a valuable contribution to reducing costs and to expanding access to life-saving treatments for patients, both in emerging markets and in developed countries. More recently we are seeing how globally, and especially in developed countries, waves of consolidation among pharma retailers, stiffer competition from Chinese pharma manufacturers and an uptick in generic drug applications have combined to put downward pressure on drug prices. India’s stock market has reacted quite negatively to these developments, wiping nearly 20 percent off the value of Indian pharma stocks between August 2016 and August 2018. Given these adverse headwinds, it is imperative that India’s pharmaceutical manufacturers create new markets to restore market confidence in their growth prospects. Fortunately, we are seeing some positive moves in this direction.

First, there is a new push to produce more so-called complex generics. These are hybrid medicines that often contain complex active pharmaceutical ingredients (the part of the drug that produces its effects) or formulations, or routes of delivery. Things are still at an early stage in this segment but the signs are promising, with Indian firms having succeeded in capturing 19 percent of the global market in complex generics thus far. A second strategy that they would be well-advised to pursue is to expand their footprint in the biosimilars market. Biosimilars are the generic versions of biologics medicines made from animal or plant proteins as opposed to chemicals. Biologics are important market disrupters because they are transforming how we treat diseases, including certain types of cancer, rheumatoid arthritis, and multiple sclerosis. Biologics are notable for targeting the underlying causes of diseases as opposed to just the symptoms, with fewer side effects.

The growth in the biosimilars market is welcome from a human development standpoint because they are more affordable than biologics, the high cost of which often puts them out of reach of many patients. While it is encouraging to see Indian firms beginning to ramp up biosimilars production, there is a lot of room for additional growth. Biosimilars currently account for just USD 5 billion of the USD 240 billion global market in biologics. Governments can support growth in this segment by clarifying the regulatory framework for them, which is still evolving in many countries. China is a recent example, where the government has identified biopharma, including biosimilars, as a priority area for the country. As for the private sector, new partnerships need to be forged to make this expansion commercially viable. Biosimilars, like biologics, require a large investment outlay both because of the high cost of product development and regulatory compliance, and the significant amount of time it takes to bring a product to market. Partnerships can make for a more cost-efficient pipeline. For example, it is often in manufacturers’ best interest to forge partnerships with contract research organizations that have the scientific expertise to develop that specific product, or with contract manufacturing organizations that have the appropriate production sites and expertise in compliance.

Further down the pipeline, they can partner up with companies that are specialized in commercializing and marketing these products and have acquired the know-how to meet the regulatory requirements. We saw a recent case of such an innovative partnership with the Mylan-Biocon joint portfolio aimed at bringing to market a biosimilar that obtained US regulatory approval. The two producers developed the product jointly and then carved out among themselves the marketing rights for different markets. There are many ways that partnerships can be structured but the bottom line is that new business models that increase patients’ access to innovative and cost-effective treatments should be encouraged. Beyond being a sound business investment, promoting the production of complex generics and biosimilars can have a positive development impact given how targeted they are toward treating non-communicable diseases such as cancer, asthma, and arthritis. We continue to make commendable progress across emerging markets in tackling communicable diseases. However, at the same time we are seeing an alarming spike across developing countries in the prevalence of non-communicable diseases.

To take one example, diabetes is fast becoming an epidemic in developing countries, with rates rapidly catching up with those of the developed world. India is a big part of this story, with 69 million diabetics in 2015, a number projected to exceed 100 million by 2030, according to the World Health Organization. The number of diabetics across the South-East Asia region, which includes Bangladesh, India, and Indonesia, rose more than fivefold between 1980 and 2014, WHO has reported. It is increasingly clear that the segment of the pharmaceutical market where we will see demand grow the fastest in the coming years is products that treat non-communicable diseases. We should, therefore, strive to promote strong, indigenous producers of complex generics and biosimilars as this has enormous potential to improve public health in emerging markets. – Livemint