DIFFERENCES IN BIOSIMILARS APPROVAL BETWEEN THE USA AND EUROPEAN UNION
DIFFERENCES IN BIOSIMILARS APPROVAL BETWEEN THE USA AND EUROPEAN UNION

Summary/Abstract: Biosimilar reviews and approvals have significant structural differences that contrast Europe and the United states. Regulatory processes and market subtleties create a divergence of the markets. This paper will review market differences between Europe and the USA and evaluate strengths and weaknesses between the two systems. The study explores the differences in terms of the approval times for the biosimilars, the differences in intellectual property rights, the effects that expiring and extended biologic patents have on the entry of biosimilars, and the effects that lawsuits have on the approval process. There are various examples from Europe that the USA could consider embracing that would lead to lower biosimilar and biologics pricing. Particularly, policy changes aimed to encourage the healthcare industry to help educate the public to address false notions of biosimilar’s effectiveness and safety as well as increasing incentives for prescriptions to include biosimilars in lieu of biologics to aid in equalizing market pricing.

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