Biogenerics companies need to focus on robust and stringent clinical trials

To capitalise on emerging opportunities, domestic producers must ready themselves with large-scale, comprehensive clinical programmes which prove the safety of their biogenerics and efficacy in the treatment of the disease they target, informs Gaurav Kaushik, MD, Meteoric Biopharmaceuticals.

What is the market potential of biogenerics industry in India? Where does it stand in comparison to other countries?

A UK-based research firm, EvaluatePharma indicates that patents worth $251 billion (approx. Rs 17 lakh crore) are expected to expire globally between 2019 and 2024. Reports suggest that around $17 billion worth of drugs worldwide will face patent expirations in 2020 alone. Of these, not all will necessarily present opportunities to manufacturers of generic or biosimilars in 2020. However, some will witness generic or biosimilar versions launched in a year or two.

Being the world’s largest supplier of affordable generic medicines, India is well-poised to capitalise on drugs whose patents have expired. In fact, developed as well as under-developed countries have become the large export destinations for Indian companies that produce generics of great quality.

What, according to you, should be an ideal model for biogenerics – in terms of R&D, manufacturing, distribution, storage capabilities and transportation, to make India a leader in this field?

To capitalise on the emerging opportunities, domestic producers must ready themselves with large-scale, comprehensive clinical programmes which prove the safety of their biogenerics and efficacy in the treatment of disease they target. These processes must also be highly controlled to ensure quality across the system. As a result, companies need to ensure highly-controlled manufacturing processes and environments, to pre-empt the risk of even minor variations that could result from unacceptable mutations to the quality of the product. Transportation and storage must also be subject to the same high quality. In fact, every aspect of production — from raw materials and equipment used as well as the people who undertake the process — must conform to the most stringent quality standards. All of this, while ensuring affordability and accessibility for the masses.

What complexities are linked to the manufacturing of biogenerics, and how can these be resolved?

India already has a significant presence and growth prospects in the biogenerics manufacturing sector. However, there are significant obstacles with respect to regulations and their compliance in other countries. For instance, the US has recently put in place policies that check the prices of such drugs. This has led to an erosion in the prices of generics. If we have better regulation within the country, it will endorse biogenerics standards produced by Indian companies, which can then be transferred to more established pharma markets.

More importantly, bio-generics companies need to focus on robust and stringent clinical trials/ processes.

Another challenge that companies in this segment typically face is that large-scale investments are required while setting up facilities or augmenting capacities since there is no scope for cutting corners. Therefore, once these facilities are up and running, they must be fully utilised to be cost-efficient.

Can innovator drug companies facilitate the development of biogenerics? If yes, how? If not, why?

There is an industry benchmark which suggests that bringing biosimilars to the Indian market could cost anywhere up to $150 million and beyond. Of this, around 80 per cent is usually spent on R&D. So, to be practical, innovation is definitely one aspect to being able to produce biogenerics, but having sufficient funding and robust R&D facilities and the ability to conduct extensive clinical trials and studies over hundreds of volunteer patients, which is expensive, is just as crucial. Besides, it takes immense commitment too.

What are the opportunities for Indian biogenerics industry in the years to come, and how can these be leveraged?

While there are plenty of opportunities emerging in the near future, the availability of adequate funding must also be facilitated.