Industry stakeholders discuss on opportunities and challenges in biosimilars at IPC 2018

Hope that in the coming years India will contribute significantly to the growth of the biosimilars sector globally

IPC 2018, on its second day, was marked by several pertinent discussions on issues which would be crucial to the industry’s glorious future.

In one such session, pharma captains and game changers came together to examine sphere of biologics and biosimilars and outline strategies for India Pharma Inc to tackle the challenges and optimise the growth potential.

The discussion, moderated by Dr Surinder Singh, Director, National Institute of Biologicals; also had eminent panelists comprising Dr Subhash Chand, Scientist-III and Head, National Institute of Biologicals; Dr Akundi V Sriram, Senior Vice President and Head Regulatory, Biocon and Dr R Chandrasekhar, Deputy Drug Controller (I), CDSCO.

The experts addressed various aspects in this sphere such as challenges in quality control strategy of biosimilars in India; regulatory requirements for approval of biosimilars and development of biosimilars from concept to commercialisation of the drug product.

Dr Singh, the moderator, set the context with a brief introduction on the topic and explained the current scenario of biologics in India. He opined that it is an emerging sector and like vaccines, the biologic sector will also a boom in the foreseeable future.

Dr Chand highlighted, “The global biosimilars market is $5.95 billion and expected to reach $23.63 billion. The Indian biosimilars market is estimated at $0.85 billion and is growing at CARG of 25 per cent.” At the same time he also informed that there are several challenges that need to be tackled. For instance, there are 20 tests and all are being outsourced, making them very expensive. Other major challenges are characterisation of biosimilars in India and lack of monographs for biologics. Insufficient information regarding clinical trials and regulatory aspects are also a problem. There is also a lack of product specific guidelines by the regulatory authorities. He cautioned that we need to bridge the gaps in biopharma innovation in the development of biosimilars. He further explained the role played by National Institute of Biologicals (NIB) in bridging the gap through training on quality control testing of biosimilars to the industry and students.

Giving insights on the regulatory requirements for approval of biosimilars in India, Dr Sriram said, “Regulatory expectations across the globe for biosimilars has evolved over time. India has come out with guidelines on biosimilars with a practical, risk-based approach. These guidelines laid a pathway regarding manufacturing process and safety, efficacy and quality aspect of biosimilars.”

Dr Chandrasekhar threw light on the regulatory framework for marketing authorisation of biosimilars. He briefed the audience on the role and responsibilities of the authority involved in the process of getting marketing approvals across the globe.

Thus, it is was an engrossing session with several key takeaways. The panelists were very optimistic that just as vaccines were a part of India Pharma Inc’s success story and over 70 per cent of the global supply of vaccines are from India, in the coming years India will also contribute significantly to the growth of the biosimilars sector globally.