Biosimilar drugs developed by Korean pharmaceutical firms are gradually carving out a U.S. market share out of Remicade, the original medicine by Johnson & Johnson (J&J) for autoimmune diseases treatment.
According to J&J’s disclosure of earnings on Tuesday, sales of Remicade (ingredient: infliximab) fell to $916 million (979.2 billion won) in the first quarter, down 22.5 percent from $1.18 billion a year earlier.
J&J attributed Remicade’s revenue decline to competition against biosimilars and discounting of Remicade.
In the U.S., Remicade is challenged by Celltrion’s Inflectra (Remsima in Korea) and Samsung Bioepis’ Renflexis (Brenzys in Korea). Celltrion started to sell Inflectra in the U.S. in 2016.
Remicade’s year-on-year sales fall was bigger in the first quarter than the fourth quarter last year. The original drug’s revenue went down by 8.5 percent year-on-year to $1.07 billion in the fourth quarter of 2017.
The latest 22.5 percent fall is the most prominent drop since the launch of inflectra by Celltrion.
Since the advent of biosimilar products in the U.S., Remicade’s revenue has been decreasing for the sixth consecutive quarter. Pfizer’s litigation against J&J negatively affected Remicade earnings, observers said.
Pfizer, which sells inflectra in the U.S., filed a complaint against J&J in September last year with the U.S. District Court for the Eastern District of Pennsylvania, claiming that J&J made inappropriate attempts to monopolize the autoimmune diseases treatment market with Remicade.
At that time, Pfizer claimed that J&J sold Remicade through U.S. insurers, delaying the entry of Inflectra by offering indirect rebates, such as selling the drug with other medicines in bundles or offering discounts to hospitals.
Janssen, the distributor of Remicade, said the company had faith in the legitimacy of the contract and that the company was competing on price to make sure that patients could use Remicade with lower costs.
Regardless of the ruling, prescriptions of Inflectra would have increased to a certain level because the U.S. market is sensitive to monopoly, price fixing, and illegal rebates.
Also, the U.S. government’s backing up of biosimilar drugs amid a high proportion of expensive drug costs being weighed on U.S. patients will help biosimilar makers enlarge their shares, analysts said.
“Increases in rebates, discounts, and biosimilar competition brought down Remicade sales. The first-quarter sales decline of Remicade in the U.S. is mainly attributed to an expansion of biosimilars’ market share. Remsima (inflectra) played a significant role,” said Shin Jae-hoon, an analyst at eBEST Investment & Securities.
“We’re anticipating that the U.S. FDA will announce a policy to enhance the biosimilar market. This will help biosimilars penetrate the U.S. market easily,” he said. “Within this year, biosimilars will be able to take up 15-20 percent of the market.”