Maximizing the Opportunity
Strategic Partnerships and Collaborations: Collaborating with global pharma companies, contract research organizations( CROs), and technology providers can accelerate biosimilar development and commercialization. For example, Biocon’ s collaboration with Viatris enabled it to successfully launch biosimilars in global markets.
Focus on High-Value Biosimilars: Rather than targeting low-margin biosimilars, Indian firms should focus on high-value biologics in oncology, immunology, and diabetes segments. Drugs like Keytruda, Opdivo, and Eylea represent significant revenue opportunities.
Investment in R & D and Innovation: To compete with established biologic manufacturers, Indian firms must enhance their R & D capabilities, process optimization, and analytical methods to develop high-quality biosimilars with faster market entry.
Expanding Global Regulatory Expertise: Strengthening regulatory capabilities for biosimilar filings in the U. S., EU, and other high-value markets will be crucial. Indian firms should establish strong regulatory teams and seek early engagement with agencies like the FDA and EMA.
Leveraging Digital and AI Technologies: Adopting AI-driven drug development, process automation, and real-time analytics can enhance efficiency and reduce biosimilar development costs. Digital transformation will play a key role in gaining a competitive edge.
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