Biosimilar Competition Leads to 9.7% Drop in Remicade Sales for Johnson & Johnson

Johnson & Johnson announced in an investor call today that it earned $20.2 billion in sales for the fourth quarter of 2017 (up 11.5% from the fourth quarter of 2016), including a worldwide increase of 5.1% in its immunology pharmaceutical segment. However, sales of the company’s Remicade (innovator infliximab) fell by 9.7% worldwide as the reference product faced competition from biosimilar drugs.

Remicade earned approximately $1.47 billion globally in the fourth quarter of 2017, compared with $1.62 billion in the same period in 2016. The overall drop in Remicade sales included an 8.5% slide in US sales, a 5.5% increase in sales of US exports, and an 18.7% decline in international sales.

In the United States, the reference Remicade faces competition 2 biosimilar infliximab products: Celltrion and Pfizer’s Inflectra, approved by the FDA and launched in the US market in 2016, and Samsung Bioepis and Merck’s Renflexis, approved and launched in 2017. In the European marketplace, Johnson & Johnson’s drug fights for market share with the same products, where Renflexis is marketed under the brand name Flixabi, and where Inflectra is marketed under 2 names: Inflectra and Remsima.

Despite seeing its profits for infliximab erode from biosimilar competition, Johnson & Johnson’s overall immunology business did report growth of 5.1% for the fourth quarter versus the same period in 2016. Johnson & Johnson said that uptake of Stelara (ustekinumab) for the treatment of Crohn disease was a key driver for growth in for immunology division. Sales of Stelara, which is also indicated for use in patients with plaque psoriasis or psoriatic arthritis (PA), were up 23.0% worldwide in the fourth quarter of 2017, reaching approximately $1.1 billion.

Also continuing to perform well were Simponi (golimumab) and Simponi Aria (an intravenous golimumab that offers less frequent dosing than the subcutaneous Simponi), a treatment for rheumatoid arthritis, PA, ankylosing spondylitis, and ulcerative colitis. Together, the 2 Simponi products were up 15.0% in the fourth quarter of 2017 versus the same period in 2016, reaching approximately $490 million.

Also today, the US Circuit Court of Appeals for the Federal Circuit affirmed a previous ruling that a patent covering the active ingredient in Remicade is invalid. The patent challenge was filed against Johnson & Johnson by Pfizer. According to Bloomberg, shares of Johnson & Johnson dropped by 2.9% after the decision, the biggest intraday decline since April 2017.