Is Europe Ahead of the USA in Biosimilars?

Abstract

This article is about a race between the USA and Europe in biosimilars. The race can be defined in several ways: the first launch of a biosimilar; the first cross-border use of a biosimilar in the USA or Europe which was approved in a neighbouring country; the greatest value or profits of biosimilars in 2004; the first legal provision for an abbreviated regulatory pathway applied in a consistent and continued manner; and the race for interchangeability or substitution of biosimilars for reimbursement, a race that is just beginning. The USA has won three of the five races, first-launch, first cross-border use and greatest value of biosimilars according to 2004 sales, but Europe is ahead in the most important race: the application of a consistent and continued regulatory pathway. This paper provides the race results and looks at the race for biosimilar regulatory pathways. Once the regulatory pathway is applied by governments in a consistent and continued manner and many biosimilars are launched, the race begins for interchangeability that affects physician prescribing and generic substitution. Biosimilar interchangeability and subsequent biopharmaceutical affordability, is the ultimate prize for the real winners of the race: the patients.