Introduction of new drugs in the form of biosimilars will bring in new drug delivery system. The Indian pharma companies are focusing and investing considerable amount on research and development for bringing advancement as well as economically viable biosimilar drugs. With alarming incidences of cancer cases, biosimilar drugs for oncology will be majorly benefitted.
Dr Piyush Gupta, Associate Director, GNH India informs about the proactive approach taken by the Indian pharma companies and its way forward to Usha Sharma
How big is the global biosimilar market and at what per cent growth is it growing?
Multiple sources that have studied this market predict varying growth rates and sizes of the market. Like any other new market that is at its nascent stage, the difficulty and ambiguity in prediction is always a factor. However, a safe assumption of the global market size would be around $100 billion with a CAGR of about 20 per cent. In India, the market could grow up to the $40 billion mark by 2030. This new form of the drug has a great untapped potential to change aspects of the pharmaceutical landscape as and when these biological drugs get approval.
Developing biosimilars require huge and high-quality research capabilities. While the Indian pharma industry is known for its generic capabilities, how do we fare in the biosimilars arena?
Here in India, biosimilars are quite an established arena and have been evolving in leaps and strides over the past decade. With a strong foundation and infrastructure and R&D in the generic space, India has the potential of being a top player in the biosimilar market. We are investing considerably in it, in the terms of both capital and efforts. The Indian pharma industry is learning and improving in biosimilars day by day showing the scope and enhancement of this sector in the country.
However, there is a long road ahead for us to be a key player. The Indian pharmacopeia has yet to join forces with local manufacturers to develop bio-similars to reduce the cost of the drug in order to make it more available and easy to access to the populous. Another factor that will allow India to be a key player is our strong R&D facilities and talent acquisition.
According to the Generics and Biosimilars Initiative (GaBI), the first ‘similar biologic’ was approved and marketed in India in 2000, some 15 years before the US approved its first biosimilar. Since then, how have we evolved and enhanced our capabilities?
The world has evolved, but the US has adopted a slow pace approach, they are waiting for the world to adopt and they will adopt after there is considerable data available for biosimilars. India being a cost sensitive market, has adopted a proactive approach in adopting biosimilars to bring down cost.
Give us five key challenges associated with the development of biosimilars drugs and what are the solutions for them?
Cost: In the process of making this drug affordable, which is one of the key features of the innovation, we have to heavily invest in biosimilars due to the lack of infrastructure and the novel services introduced while creating the biosimilar drugs.
Time: The process is stretched due to the hassles in the regulatory procedure and disruption in the process can be resolved by the increase in awareness of the criticality and importance of this arena. Availability of innovator drug for R&D trials: The trials are an important part of R&D. The innovator drugs undergo a lot of research and experiments to lead to an outcome of an effective biosimilar drug. Thus, there is a need for ready availability of the innovator drugs. The solution to this problem is to increase the accessibility of the innovator drug and give more impetus to the sector.
Rigid regulations: The rigid regulations and the interference of the authorities in the procedure are quite profuse. The easing out of the process could help attract investment and development in the biosimilars sector.
Cold chain: Cold Chain transportation is required at every step which is quite costly. The transportation of the drug, be it the innovator drug or the final product, needs cold storage. The need for cold storage transportation throughout the process of developing a biosimilar makes it a costly undertaking.
Which therapeutic areas will gain from biosimilar drugs? How will it also drive growth in drug delivery systems?
The therapeutic area that will majorly benefit by the biosimilar drugs is that of oncology. It ensures high quality and effective medication at a reduced cost for the benefit of therapy in the long run. The introduction of new drugs in the form of biosimilars will bring in new drug delivery system along with it thus advancing the existing drug delivery system in India and thereafter, the world.
Will biosimilar drugs be economically viable for chronic ailments?
Biosimilars are aimed at curing the patient. It is not a palliative care or a medium that can be used to prolong life. The affordability of the drugs makes it economically viable to ensure the complete treatment of the ailment.
What support is the industry looking for developing this sphere from the government?
The major support that is needed by the government is the ease of the procedure in conducting trials. The regulatory framework and process time and time for approval at each stage need to gain efficiency.
What role will GNH India play in driving development in biosimilars?
We have been in this arena for the past 12 years. Our services provide the most crucial phase of the sourcing of the innovator drugs starting from candidate selection right up to the phase IV trials.