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
References
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
FTC Releases Second Report on PBMs Meddling in Generic Drug Markets
January 19th 2025The 3 largest pharmacy benefit managers (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Biosimilars Drive Cost Savings and Achieve 53% Market Share Across Treatment Areas
January 16th 2025Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to Samsung Bioepis’ most recent market report, showcasing notable pricing trends and market share disparities across therapeutic areas.