How BioPharma SHAKTI can transform biologics with non-animal models, PgII

Key Highlights:

• The BioPharma SHAKTI strategy, announced in the 2026 Union Budget, aims to boost domestic production of biologics and biosimilars in India.
• Non-animal methodologies (NAMs) like organoids and organ-on-a-chip are being promoted to replace animal testing for biologics development.
• The New Drugs and Clinical Trials (Amendment) Rules 2023 supports the use of NAMs in novel drug development in India.
• Patent evergreening and slow regulatory approvals by the CDSCO pose challenges to the biosimilars market.

Detailed Insights:

• The Northwick Park Tragedy in 2006 highlighted the limitations of using animal models to predict human drug reactions, particularly for monoclonal antibodies (mAbs).
• NAMs offer more human-relevant systems for testing biologics, potentially reducing drug development costs by 10-26% and lead optimization time by 19%.
• BioPharma SHAKTI, with a budget of ₹10,000 crore, can support the development and commercialization of NAMs by academic labs and pharmaceutical companies.
• Challenges to the biologics industry in India include limited investment, lack of investor understanding, and the need for stronger supply chain support.
• Updated guidelines from the CDSCO are needed to expedite the adoption of NAMs in the biologics and biosimilars field.

Key Concepts Involved:

• Biologics: Large, complex drugs produced by living cells, used to treat chronic diseases.
• Biosimilars: Generic versions of biologics, reverse-engineered after the original product's patent expires.
• Non-Animal Methodologies (NAMs): Human-relevant, bioengineered systems like organoids used to replace animal testing.
• Patent Evergreening: Extending the market exclusivity of an original biologic through new patents on modified versions.

Biologics and Biosimilars