A European perspective on the market accessibility of biosimilars

Abstract: Biopharmaceuticals are complex molecules produced by living cells. Copies of these drugs, called biosimilars, are not identical to their reference medicine, and therefore specific regulatory requirements for registration apply. Pharmaceutical quality evaluation requires a complete dossier and a detailed comparative analysis to the reference drug. However, nonclinical and clinical requirements are much less extensive compared to the requirements for an innovator. Therefore, at the time of introduction onto the market, only limited clinical experience is available for the biosimilar. Differences of 15%–30% between the acquisition price of biosimilars and their corresponding reference biopharmaceuticals have been suggested in the literature. Although the percentage price difference between reference biopharmaceuticals and biosimilar medicines may be limited, absolute savings are still likely to be substantial when calculated with respect to expensive reference biopharmaceutical medicines. Although an economic evaluation needs to be carried out in an increasing number of European countries to inform reimbursement decisions, uncertainty exists about how such an economic evaluation should be conducted for a biosimilar. The assessment of the cost-effectiveness of a biosimilar for reimbursement purposes depends primarily on the relative efficacy, given that a biosimilar is likely to be less expensive than the reference biopharmaceutical. To date, the question of meaningful differences in efficacy between biosimilar and biopharmaceutical drugs has not been answered. Due to a lack of demand-side incentives, biosimilar medicines have enjoyed limited success in Europe to date. Other factors that inhibit the market accessibility of biosimilars include the limited number of companies that have the expertise and the financial ability to manufacture, gain marketing authorization for, and commercialize biosimilars; physician brand loyalty to reference biopharmaceutical medicines; application of rebate contracts to reference biopharmaceutical medicines following expiry of protection; and life-cycle management strategies of companies marketing reference biopharmaceutical medicines. Keywords: biopharmaceutical, biological medicine, registration, pricing, reimbursement