On November 5, 2019, Ha Kung Wong and Erica Norey published "Will Authorized Biologics Disrupt the Market for Biosimilars?" in Biosimilar Development. The following is an excerpt:
Authorized small molecule generics have been subject to some controversy. Some take the view that an innovator's launch of an authorized generic is anticompetitive by design and implemented solely to discourage generic entry into the market by undercutting a generic's ability to turn a profit, leading to less ANDA filings and generic competition over time. Others believe that they are procompetitive, by not only offering an immediate lower cost alternative to consumers but also by providing more competition in the generic marketplace which may lead to lower prices for consumers. With the passing of the Biologics Price Competition and Innovation Act (BPCIA) in 2009, and a recent increase in biosimilar activity in the U.S., this same debate has started to enter the fledgling biosimilar space, leading commentators to ask whether we will see "authorized biologics" / "branded biosimilars" in the near future and how that might affect the biosimilars marketplace.