Tracking biosimilar trends

In an insightful article, Debayan Ghosh, President & Founder, Epygen Biotech, highlights that biosimilars bear the potential to rationalise spending on drugs in developed economies and provide access to this critical driver of societies in the developing world 

The Indian pharmaceutical industry is likely to be in the top 10 global markets by value by 2020 because of the healthy growth in the industry. It is estimated that by 2022, small molecule pharma drugs growth curve will be taken over by biotech drugs.Latest technologies like real time data sharing, smart devices, mobile health and innovations in health insurance and diagnostic technologies have helped the industry to surpass the provision of healthcare services. Shaping up the overall
region, there have been many regulatory interventions and amendments in the past couple of years that pharma companies must consider as they plan their future strategies. On the other hand, biotech industry in India seems to be getting bullish with robust regulatory framework being laid down in line with the top of the world and biotechgiants like Biocon making foray in the US oncology heartland with one of the most potent biologics in the present times.

According to PwC report: Pharma 2020; India’s pharma industry looks set for a solid long-term growth. It is already ranked 14th in the global league table, with sales of almost $19 billion in March 2009. However, PwC estimates that it will rise to approximately $50 billion by 2020 – a 163 per cent rise in the span of 11 years, which is surely going to be surpassed. Pharma vs biotech, a five years outlook
It is estimated that biotechnology drugs will continue to rise, contributing to 50 per cent of the top 100 pharma sales by 2022. The biologics climb is expected to continue as novel biologic blockbusters keep entering the healthcare 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 the 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.

Biosimilars

US FDA defines biosimilars as — A biosimilar is a biological product that is highly similar to a US-licensed reference biological product notwithstanding
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.

History is going to repeat itself. In the US, 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 pricey in the first place. While many biologics are addressing significant unmet medical needs, they are unaffordable to many. Some of these therapies cost upwards of $100,000 per treatment course on an annualised basis. There is no doubt that biosimilars bear the potential to rationalise spending on drugs in developed economies and provide access to this critical driver of societies, in the developing world.

As per Assocham, the biosimilar opportunity is mounting as novel biologics continue to go off patent:

As per Evaluate Pharma, around $23 billion biological novel products sales are at risk in 2019 alone, from monoclonal antibody technologies alone in the area of breast cancer and rheumatoid arthritis. Some technology stats: Around 1,500 follow-on biopharmaceuticals are in development today, including more than
750 biosimilars. These pipeline products cover more than 150 reference products (nearly all of which are recombinant). In terms of regulatory status, nearly currently 350, are in preclinical development.

Indian biosimilar research

R&D expenditure for biosimilar development in India increased substantially to $1.4 billion during the year ended March 2015, a 28.8 per cent increase from
$1 billion in the previous year. [Source: OPPI November 2015-Assocham]. This increased R&D expenditure is 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.

One very important aspect of the biosimilar business is that, it certainly is not everyone’s cup of tea. That is why only 10-15 companies in India truly made a footing into this segment, when several hundred small molecule pharma companies crowd the floor. While the global biopharma industry has made significant progress in mastering the complex science behind manufacturing a biosimilar, it still remains a hurdle for Indian companies, who traditionally had been focussing on scales of producing generic drugs, but missed out on the advancements in the industry. No doubt, with a number of Indian companies now jumping into the biosimilar segment, taking special cognisance of the critical technology aspects, the barrier from a technological standpoint has significantly come down. However, it will continue to remain an important consideration for any newcomer trying to enter this segment, who does not have background in fermentation, protein purification and DSP and the associated regulations. In near future, it is critical that these biosimilar aspirants streamline their regulatory compliance in wake of the new stipulations, with respect to the producing and processing of molecules as well as clinical trial data. This will open up the golden gates to a much larger global biosimilar market, potential changing the game of Indian biosimilars. Challenge will now evolve beyond developing a biosimilar molecule that is a fingerprint copy of the original, to achieving a bio-better, more efficient and safer protein for patient with a further improved profile, maintaining all the proofs of biosimilarity, with a key focus on optimisation of processes and costs without compromising time to market.

Companies in the biosimilar space must consider the following points:

• How will you acquire the desired success amongst unmatched strategic and policy uncertainty in the region?
• How will you phase and transform from volume to value?
• How will the new age realities emerging from artificial intelligence and advanced analytics improve your R&D and commercial outcomes?

Further, to prioritise the value of a drug over the volume in the years to come, it is important to consider multi-stakeholder platform. This could be
a structured collaboration between manufacturers, payers, healthcare systems, data providers and adjudicators that are designed to explore value-based contracts in a safe forum, paving path to the new dawn of healthcare.