The last panel discussion of FDD Conclave 2021 was on ‘Biologics and Biosimilars: Challenges and opportunities in FDD’. In this discussion, our eminent panelists sought to understand and address the formulation challenges in biologics and vaccines, understand the potential of less traditional delivery routes, regulatory and quality issues, emerging therapies etc.
Dr Shrikant Mishra, Professor & Head, Technology & Translation Laboratory, School of Biotechnology, KIIT University, Bhubaneshwar (Moderator); Dr Jaby Jacob, Sr President – R&D, Bharat Serums & Vaccines; Dr Dinesh Kundu, Co-founder & CEO, QbD Biosciences; Jayant Gangakhedkar, Asst Drugs Controller (I), Biologicals Div, CDSCO; and Dr Ramakrishna Bangaru, Sr VP, Clinical Pharmacology Research, Viatris were the participants in this discussion.
The panelists discussed the progress in this field and the emerging opportunities, in India and globally, in this arena. One of them informed that though only 10-20 biologics have been approved in the last 15-20 years, over 470+ trials have been reviewed in the past 18 months, thus signifying how the COVID19 pandemic has accelerated growth. At the same time, they also discussed the myriad challenges that exist and are emerging in this segment and deliberated on the various approaches to tackle them.
Dr Mishra, an industry veteran and an academician, as the moderator for this session, steered the discussion to address several pertinent aspects in biologicals and biosimilars such as evolving regulations and ways to comply with them, quality and non-compliance issues, FDA rejects and recalls of these products, measures to leverage opportunities and minimise restraints, importance of training the human resources to optimise growth potential and more, during the course of this discussion.
Dr Jacob elaborated on formulation challenges in biologics and biosimilars such as stability issues, storage requirements, viscosity, complexities in formulation, and how they have been overcome. He spoke on quality issues and non-compliance in marketed drugs of rDNA origin. He also gave details on the opportunities and growth potential in this field. Dr Kundu shared information on regulatory issues in MSC therapy, Plasma therapy, and COVID-19 specific MAbs. He informed that more than 670 development programmes have been initiated for COVID-related treatments and vaccines in two years across the globe.
Gangakhedkar from the CDSCO, on the other hand, gave the regulator’s perspective and detailed on the various pathways and measures taken by the regulatory authority to ensure quality, safety and efficacy of biological drugs. He assured that there are multiple stringent checks done at multiple levels, before regulatory approvals are given to biological and biosimilars in India.
Dr Bangaru shared information on the regulatory approval process for biologicals and biosimilars and gave insights on the different kinds of recalls, their causes and impact. He cautioned that these recalls actually hurt both the industry and the patients. The pharma companies have to deal with loss of time, money and reputation while the patients have to face issues with drugs that are not top quality. Hence, it is essential to prevent or minimise them by ensuring top most quality and regulatory compliance. Thus, the discussion had a lot of learnings and takeaways for the audience of the