About Challand Biosimilar Consulting

About company

The race for pharmaceutical companies to get their biosimilar products to market has intensified as patent expiry dates for a number of top-selling biological products have passed for many and for many others draw nearer. The regulatory pathways for the approval of biosimilars are well developed and tested globally. Many countries throughout the world have established legal and regulatory pathways which allow development of biosimilar products. However, guidelines are not prescriptive and with significant advances in the scientific and analytical techniques e.g. in the field of physicochemical characterization combined with vast experience gained by the Regulatory Agencies over years of approving biosimilar products, the clinical requirements for any product is changing with time. Furthermore, biologic products are not identical, the quality and non-clinical packages for each product are different, and the commercial objectives of each client is different.