The U.S. sales of Johnson & Johnson's (J&J) Remicade, a blockbuster antibody, fell 19 percent last year due to fierce competition from biosimilars developed by Celltrion and Samsung Bioepis.

Remicade treats Crohn’s disease, adult ulcerative colitis, ankylosing spondylitis, adult plaque psoriasis, psoriatic arthritis, and rheumatic arthritis.

According to the J&J’s earnings report for 2018 released on Tuesday, Remicade recorded sales of $3.6 billion in the U.S. last year, a 19 percent drop from the $4.5 billion in 2017.

Notably, the sales decline in the fourth quarter was more drastic. During the three months, the total sales for Remicade were $843 million, down 21.4 percent from $1 billion in the same period of the previous year.

The company’s global sales also declined from $6.3 billion in 2017 to $5.3 billion last year. The fourth quarter also fell from $1.4 billion to $1.2 billion over the cited period.

“Sales for Remicade dropped due to increased discounts and rebates, as well as the market share loss to biosimilar competition,” the company said.

However, J&J said it remains optimistic about keeping Remicade’s market dominance. Although it has now been a year since Inflectra and Renflexis, biosimilars developed by Celltrion and Samsung Bioepis, have launched in the U.S., J&J’s Remicade still holds a 93 percent market share.

The company has maintained large shares as Inflectra and Renflexis have received U.S. Food and Drug Administration’s approval only as a biosimilar and not an interchangeable product.

Such approval means that while patients can receive both drugs for the same indications as Remicade, the drugs need to obtain a prescription from a physician or clinical decision-makers and cannot be substituted at the pharmacy level.

Despite such obstacles, the two biosimilars are slowly expanding its presence in the U.S., industry watchers say.

Celltrion’s Remsima has been expanding its market share in the U.S. with sales of $189 million by the third quarter of last year. Pfizer, Remsima’s distributor in the U.S., has not yet published its final earning report for 2018, but the total sales for the drug last year are likely to surpass $250 million.

Merck, known as MSD outside of U.S. and Canada, also has an exclusive five-year agreement worth $174.9 million with the U.S. Department of Veterans Affairs to market Samsung Bioepis’ Renflexis.

Moreover, the recently pro-biosimilar stance of the U.S. government will likely help the two companies to expand their market shares in the U.S., the experts said.

In May last year, U.S. President Donald Trump announced the “American Patients First” policy, which includes his administration’s plan to lower drug prices and reduce out-of-pocket costs.

Trump said, “One of my greatest priorities is to reduce the price of prescription drugs. In many other countries, these drugs cost far less than what we pay in the United States. That is why I have directed my administration to make fixing the injustice of high drug prices one of our top priorities. Prices will come down.”

The plan’s central goal focuses on increasing competition, easing negotiation, creating incentives and lowering out-of-pocket spending on drugs to reduce their prices.

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