Radiology and Oncology

Background & Aim: With the presence of concept of biosimilar products at last decade which defined by WHO as a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product. Interchangeability concepts for Biosimilars were raised by the payers to develop multidisciplinary tools for policy analysis which is the main core of Health Technology Assessment (HTA). The main objective for this study is to determine the roles that can HTA body play for biosimilar products starting from regulatory step finished by decision for reimbursement.

Method: Integration between a systematic literature review and descriptive analysis of (FDA, WHO EMA, local guidelines and local data from regulatory body for efficacy, safety, quality) for biosimilars and ISPOR guidelines for HTA. Interviews was conducted with key stock holders for health system in Egypt, Tunisia, Jordan and Saudi Arabia, United Arab Emirates, Spain, Turkey, Germany and industry representative.

Results: A framework was proposed for biosimilars reimbursement decision making which included price and four non-price criteria. Pharmaceutical price (20% weight), quality module (33%), regulatory body approval for interchangeability (25%) post marketing studies (11%) clinical decision (11%).

Conclusion: Biosimilars should not be treated as generic products. In terms of HTA there is a need to conduct a selection criteria specialized for biosimilars; pricing process should be on case by case basis due to the nature of technology of biosimilars. The need for evidence base data for switching from innovator products to biosimilars should be mandatory during marketing authorization process. Integration between regulatory body and HTA should be initiated. As both bodies differ for their prospective and they need to integrate in order to minimize time consumption and unifying concepts for biosimilars. Effective assessment and evaluation for biosimilars, the comparator of HTA should be a different standard of care may and may not contain the reference product or second generation of Biosimilar.