Abstract

Following the recent approval of infliximab in the EU, the objectives were to understand EU payer and physicians expectations of the new biosimilars. How could biosimilars influence payer and physician decision-making and what must manufacturers do to achieve success? Secondary research to understand payer drivers & local decision-making processes followed by 1:1stakeholder interviews with 12 EU physicians on decision-making committee’s and 6 EU Senior payers. Awareness of biosimilars amongst physicians is currently low. Just 8% of physicians questioned in the EU spontaneously mentioned biosimilars as products in development, with Remsima/Inflectra the only biosimilar mentioned specifically by name. Only 35% of the physicians said they would definitely consider prescribing biosimilars for Rheumatoid Arthritis within one year of launch. Payers are anticipating a 30% saving verses the originator drug. Payers warned that manufacturers need to treat biosimilars as if they were branded medicines, and ensure a proper commercial strategy. The recent approval of Hospira’s Inflectra (infliximab) may mark a turning point for biosimilars in Europe. While follow-on biologics have been on the EU market since 2006, Inflectra was the first such approval for a monoclonal antibody – larger, more complex molecules than the 14 biosimilars previously cleared by the EMA. The broader context is that the exhaustion of patent and other intellectual-property rights on originator biologicals over the next decade affords an unparalleled opportunity for biosimilars to enter the market and boost competition in the sector. However, manufacturers will have to ensure that biosimilars are sensibly price and also put proper sales and marketing support behind the product to address the low awareness amongst physicians and local payers.

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