Profitability in the Biosimilars Market: Can You Translate Scientific Excellence into a Healthy Commercial Return?

摘要

The biosimilars space offers significant commercial opportunity. About US$60 billion of branded biologic sales will lose patent protection over the next few years, including some of the largest-selling monoclonal antibodies (MAbs). Companies are jostling among themselves, each seeking the best position to exploit that opportunity. Regulators are creating and refining the necessary pathways to success, alliances are being forged, and companies are being acquired. Despite the significant opportunity for biosimilar MAbs, significant risks remain. Perhaps the most significant of those is the potential for limited profitability, a concept that has not received sufficient coverage within the biosimilar debate. Biosimilar MAb profitability will be affectedby longer-than-anticipated clinical development timelines, higher-than-expected sales and marketing costs, low physician adoption rates, aggressive competition from other biosimilar players, originator company pricing strategies, and originator lifecycle management (LCM) strategies for developing new, related products and formulations.