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The scope of biosimilars in Indian market

Debayan Ghosh
Wednesday, January 10, 2018, 08:00 Hrs  [IST]

Biotechnology drugs will overtake small molecule pharma drugs in coming decades. As per EvaluatePharma report, use of biotech drugs will continue to rise, contributing to 50 per cent of the top 100 pharma sales by 2022. The uptake of biologics is expected to continue as novel biologic blockbusters keep entering the pharmaceutical market. The penetration of biotech products is set to increase from a 24 per cent market share in 2015 to 29 per cent in 2022. According to a latest forecast, in 2022, 50 per cent of the value of the top 100 products will come from biologics as established chemical products drop off the patent cliff and new breakthrough biologics get approved.

The US FDA defines biosimilars “a biosimilar is a biological product that is highly similar to a US-licensed reference biological product not withstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity and potency of the product”.

Taking a leaf from small molecules, in the US alone, generics accounted for 86 per cent of all dispensed retail prescriptions in 2013. This saved their economy around $200 billion. Cost savings, affordability and access becomes tantamount for biologics, being pricy in the first place. While many biologics are addressing significant unmet medical needs, they are undoubtedly expensive and unaffordable to many. Some of these therapies cost upwards of $100,000 per treatment course on an annualized basis. There is no doubt that biosimilars bear the potential to rationalize spending on drugs in developed economies and provide access to this critical economic driver, in developing economies.

As per white paper published by Assocham the biosimilar opportunity is mounting as novel biologics continue to go off patent.

Indian biosimilar research spend
R&D expenditure for biosimilar development in India increased substantially to $ 1.4 bn during the year ended March 2015, a 28.8% increase from $ 1 bn in the previous year. [Source: OPPI November 2015-Assocham]. This increased R&D expenditure results from the engagement of lifescience companies from large biopharma, major generic companies, young biotech JV ventures and start-ups developing skills for biosimilars manufacturing. It is reported that there are more than 10 companies in India, genuinely developing biosimilars for the highest selling monoclonal antibodies of the world.

Even globally, the technology development landscape for biosimilars reflects deeper engagement. The current vibrant landscape includes companies across the spectrum of large, mid-sized and smaller ventures. With several active global programmes on biosimilar opportunities, there is a good possibility today to partner for technology access. While technology still remains key to competitive biosimilar business, its threat as a barrier is diminishing given the expanded global partnership possibilities.

Regulatory impact on biosimilar revolution
In 2005, the first biosimilar regulatory framework was launched by the EMA opening possibilities for biosimilars in the European Union. This paved path for launch of 21 biosimilar products in EU and many countries adopted the EU principles in their guidelines, making high quality biosimilars more accessible to people. Though in the US, a legal framework for biosimilars was established in 2009, Filgrastim was the first biosimilar approved in 2015. Till today, US FDA has approved only 4 biosimilars granulocyte colony-stimulating factor, a follow-on biological of insulin and two monoclonal antibodies. Biosimilar regulatory frameworks have been guided for most emerging markets with EMA being the leader, regulations still long way to go in China and Russia. Until recently, the US FDA has been strongly obstructing promotion of biosimilars approval, despite BPCIA’s instructions to FDA for implementing a framework balancing biologics' and biosimilars' manufacturers and consumers interests.

In Europe follow on monoclonal antibody product adoptions are setting trend as higher than expected price erosion resulted in significant share of the innovator drug being gained by the biosimilars within years of launch. While other developed countries had a late response to regulatory framework for biosimilars, with the various changes in insurance and healthcare policies in the US (e.g. Obama care reversal) approval of multiple biosimilars in the US market including path breaking Trastuzumab approval from Biocon/Mylan and insulin Glargine biosimilar in Japan, has made the tremendous opportunity in these countries, evident.

The Rest of the World (Africa, Asia, Mena, Australia, New Zealand) markets remain an important potential for biosimilars, owing to the number of patients that needs the critical medication and lower regulatory barriers. However, the range of local regulatory practices that deviates from standard biopharma guidelines, along with lack of biotech ecosystem in these countries to understand and support biosimilar development and its usage, offers hurdles.

Indian perspective
On the other hand, biosimilar guidelines in India were laid down in 2012 and further amended in August 2016. The regulatory bodies made responsible for approval of ‘similar biologics’ in India were Department of Biotechnology, Review Committee on Genetic Manipulation, and the Central Drugs Standard Control Organization. India has approved more than 70 biosimilars till now with a robust preclinical and clinical data requirement to establish similarity with the reference drug.

To further strengthen regulatory framework, post marketing phase IV studies were introduced, which includes a predefined single arm study of more than 200 evaluable patients and compared to historical data of the reference product. The study has been advised to be completed within two years of the marketing permission/manufacturing license unless otherwise justified. This matches with the highest requirement standards of proof of biosimilarity worldwide and further prepares Indian companies to be able to face international regularity needs.

The launch of biosimilars in India had the primary motive of making these critical drugs affordable to the people in the country and the region, as in most cases the innovator biological drugs were beyond reach.

Affordability of biosimilars will be the most important factor for growth in India and other ROW markets. However, price erosion in these markets is not expected to be greater than that of Europe. To use as a reference, examples from Europe will continue to set price erosion patterns across global markets.

There is no doubt that the Indian market for biosimilars is getting competitive and busy and will continue to be so. While the number of Indian companies to make it to the developed markets could only be few, the Indian market itself will continue to see multiple players including several international companies marketing products in India through collaborations. Being yet to be so organized, largely out-of-pocket cash driven market, it is a big task to accommodate the paradigm shift resulting from upsurge of biosimilars, a business which was traditionally dictated by multinational corporate inventors. Like the several collaborations in the Indian biosimilar segment for product development and technology, companies should extend their experience learnt from international collaborators to develop a workable business model to seize this domestic sales opportunity.  

(Author is with Epygen Biotech Pvt. Ltd.)


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