Biosimilars and Biologics: Trends, Threats and Opportunities in FDD

‘Biosimilars and Biologics: Trends,Threats and Opportunities in FDD’ was the topic of the last panel discussion at FDD Conclave 2021. Our distinguished panelists discussed the formulation problems in biologics and vaccines, the possibilities of less traditional administration channels, regulatory and quality issues, new medicines, and other topics.

Dr. Shrikant Mishra, Professor and Head, School of Biotechnology, KIIT University, Bhubaneshwar (Moderator); Dr. Jaby Jacob, Sr President – R&D, Bharat Serums & Vaccines; Dr. Dinesh Kundu, Co-founder & CEO of QbD Biosciences; Jayant Gangakhedkar, Asst Drugs Controller (I), Biologicals

The speakers highlighted the advancements in this sector as well as the emerging potential in this arena in India and throughout the world. Although barely 10-20 biologics have been authorized in the last 15-20 years, over 470+ studies have been assessed in the last 18 months, indicating how the COVID19 pandemic has expedited its spread. At the same time, they debated the various methods to dealing with the numerous difficulties that exist and are rising in this market.

During the course of the session, Dr. Mishra, an industry veteran and academician, guided the discussion to address several important aspects of biologicals and biosimilars, including 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 minimize restraints, the importance of training human resources to maximize growth potential, and more.

Dr. Jacob discussed how to address formulation obstacles in Biosimilars and Biologics, such as stability concerns, storage needs, viscosity, and complications in formulation. He discussed quality difficulties and non-compliance in commercialized rDNA-derived medications. He also discussed the prospects and possibility for growth in this industry.

Dr. Kundu discussed MSC treatment, Plasma therapy, and COVID-19 specific MAbs regulatory problems. In the last two years, he said, more than 670 development programs for COVID-related therapies and vaccines have been launched throughout the world.

On the other hand, Gangakhedkar of the CDSCO presented the regulator’s point of view and detailed the various pathways and measures taken by the regulatory authority to ensure the quality, safety, and efficacy of biological drugs. Before biological and biosimilars are awarded regulatory approval in India, he guaranteed that various thorough inspections are performed at different levels.

Dr. Bangaru discussed the regulatory approval procedure for biologicals and biosimilars, as well as the many types of recalls, their reasons, and their consequences. He warned that these recalls are harmful to both the business and people. Pharma businesses must cope with lost time, money, and reputation, while patients must deal with problems caused by low-quality pharmaceuticals. As a result, it is critical to prevent or reduce them by assuring the highest level of quality and regulatory compliance.

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