Is Global Biosimilar Development Possible?

Fundamental challenges currently confront global biosimilar development because of dramatic differences in regulations and experience in key countries. The key to success for biosimilar products will be the ability to access global markets based on a single development program that meets the requirements of all markets.

The current EMEA Directive on biosimilar products offers a flexible framework for the development and introduction of biosimilar products. Other major markets – notably the US – need to make significant strides toward establishing similar regulations if follow-on proteins are to move forward in the rest of the world. Ultimately, the future of biosimilar development depends on the establishment of a practical, harmonized approach for the approval and marketing of these products by international regulatory agencies such as WHO.

Biosimilar developers also face the challenge of convincing physicians, patients, and payers about the safety and efficacy of follow-on proteins. Reimbursement by insurers and uptake by the healthcare community are not givens for these products. Patients and physicians may resist treatment changes for chronic illnesses, and payers will be seeking data-driven evidence that biosimilars offer greater value than the reference therapy.