biosimilars, which provide detailed instructions on study design, storage conditions, testing intervals, and analytical methods for demonstrating similarity to the reference product.

• WHO Guidelines on Stability Testing for Biosimilars

Step 2: Develop a Stability Testing Protocol

Create a stability testing protocol that includes specific tests for biosimilars, such as potency, purity, structural integrity, and biological activity. Ensure the protocol addresses the need to compare the biosimilar to its reference biologic product under various conditions.

Step 3: Conduct Stability Studies

Implement the stability testing plan according to the WHO guidelines. Use validated methods to evaluate the biosimilar’s stability over time under long-term, intermediate, and accelerated conditions.

Step 4: Analyze Data and Submit Reports

Analyze the stability data to determine if the biosimilar meets the acceptance criteria and remains comparable to the reference biologic. Prepare detailed reports for submission to regulatory authorities, demonstrating compliance with WHO guidelines.

Practical Tips, Tools, and Resources

Tip 1: Use Comparative Analytical Studies

Conduct rigorous comparative analytical studies between the biosimilar and the reference product to demonstrate stability equivalence.

Tip 2: Monitor Batch Consistency

Ensure consistency across different batches of the biosimilar to establish robust stability data.

Conclusion

Conducting stability testing for biosimilars in compliance with WHO guidelines involves thorough planning and a detailed understanding of regulatory requirements. By following these steps, companies can ensure their biosimilar products meet all necessary standards for safety, efficacy, and quality.