Inflectra, Pfizer’s infliximab biosimilar to Johnson & Johnson (J&J)’s Remicade, and the first FDA-approved infliximab biosimilar, became available in the United States in November 2016.1 There is still only a short history of how the first infliximab biosimilar is competing with its reference product, Remicade in the United States, and there is much interest in whether Inflectra has the potential to become a top seller for Pfizer, cut into the blockbuster Remicade’s sales, and potentially offer a cost savings.
Some clues about how Inflectra might compete with Remicade may be seen by looking at fourth-quarter 2016 sales figures. Analysts also look at how the 2 drugs are competing in Europe, where Inflectra, which is also marketed as Remsima, has been available since 2015. Merck markets Remicade in Europe.
In 2015 J&J and Merck reported Remicade sales of $6.56 billion and $1.8 billion, respectively. But in 2016, after infliximab biosimilars launched in both Europe and the United States, sales of the drug fell, first in Europe, and then, in November, in the United States.2 Merck reported a year-over-year drop in sales of 29% in 2016, and J&J reported a 1.7% year-over-year drop in US sales of Remicade in the fourth quarter, following a 9.4% year-over-year growth in the third quarter. According to J&J statements, Inflectra is not yet affecting Remicade’s market share, suggesting that J&J may be discounting Remicade’s price in order to maintain market share.2
Pfizer’s fourth-quarter earnings showed that its biosimilars’ revenue rose 48% from 1 year ago, largely because of Inflectra’s US market launch in November 2016. In the fourth quarter, Inflectra had $61 million in sales (up from $30 million a year ago) despite the fact that Inflectra is selling in the US at only a 15% discount to Remicade—a reduction that is far lower than the savings Remicade biosimilars offer in Europe, where they have been sold at discounts of 45% and higher.3 The US sales of Inflectra may be relatively lower because, unlike in Europe, it cannot be automatically substituted for Remicade—the FDA has not designated Inflectra as interchangeable with Remicade. In a 2015 interview, Adam Schechter, Merck’s president of Global Human Health and executive vice president, noted that the company was not seeing a major impact from substitution of a biosimilar for Remicade.4
Thus, the 15% discount on Inflectra, viewed as an incentive to attract new patients to start on the biosimilar, may not be enough to influence stable patients to switch from Remicade. If health insurance companies embrace Inflectra because it is a lower-priced option for Remicade, Inflectra could eventually take more than the 10% to 15% of a US market share, which J&J estimates to be $4.4 billion.2