Johnson & Johnson's (J&J) is going all out to maintain the dominance of Remicade (Ingredient: infliximab) by fending off biosimilars from entering the U.S. autoimmune therapeutic market.
The fight has already led to three suits, with two accusing J&J of abusing its power to preclude competition for Remicade, and one from J&J against Samsung Bioepis for infringing on its patents.
Remicade treats Crohn’s disease, adult ulcerative colitis, ankylosing spondylitis, adult plaque psoriasis, psoriatic arthritis, and rheumatic arthritis. It is the fifth best-selling drug worldwide and J&J’s top-selling pharmaceuticals with an annual global sale of $6.7 billion last year, making it a flagship product for the company to maintain.
However, with the recent release of biosimilar products, including Celltrion’s 셀트리온 Inflectra and Samsung Bioepis’ 삼성바이오에피스 Renflexis, J&J is struggling to maintain market shares for Remicade in the United States.
For example, Inflectra’s market share in the Norway and Denmark stood at 93 and 96.2 percent wiping out the Remicade market share. Its EU market share also stands at 46 percent as of the second quarter of 2017, according to a report released by Celltrion.
Regarding the U.S. market, J&J has somewhat successfully fended off Remicade’s biosimilars. Despite drops in sales compared last year, Remicade is still the most sold infliximab product in the market with $1.2 billion in sales in the third quarter, compared to $34million recorded by Inflectra.
The near-monopoly of the drug has led to suits from the United Food and Commercial Workers Local 1500 Welfare Fund (UFCW), the largest grocery worker union in New York, and Pfizer, which markets Inflectra in the U.S., for anti-competitive behavior.
The UFCW filed an antitrust lawsuit at the Pennsylvania federal court on Oct. 27, accusing J&J of abusing its monopoly power to exclude competition for Remicade and resulting in higher treatment price for its union members. Pfizer also filed a similar suit against J&J at the same court for anti-competitive practices in September.
Both the union and Pfizer stated that J&J’s sales maneuvers featured exclusionary contracts with insurers, coercive rebate policies, and anticompetitive bundling, all of which were designed to block insurers from receiving reimbursement and keep hospitals from purchasing Remicade’s biosimilars.
Unlike Korean insurance market, which is operated by the government, private insurance companies control a significant portion of insurance in the U.S.
Therefore, it is essential that underwriters apply coverage to biosimilars to lower the latter’s costs. However, J&J’s exclusionary contracts allegedly require insurers to only cover and reimburse Remicade, which makes patients financially responsible for switching to a cheaper biosimilar version.
Janssen Biotech Inc., a subsidiary of J&J, stood by Remicade in response to an e-mail inquiry from Korea Biomedical Review.
The company argued that it was competing fairly in the market and Inflectra had just failed to demonstrate sufficient value to patients, doctors, and insurers.
“Like other biologics, Remicade is a complex, infused treatment for serious chronic diseases. Biosimilars are not generics, and their availability will not create the same competitive dynamic as generics,” a company spokesperson wrote. “Therefore, Celltrion’s biosimilar (Inflectra) is not the same as Remicade, and due to its limited data across multiple indications, doctors may have reservations.”
Regarding J&J’s statement, Celltrion refuted that J&J’s assertion is illogical.
“Although Inflectra has less clinical data compared to Remicade, it is a licensed biosimilar that meets all the criteria for proving the similarity required by the U.S. Food and Drug Administration (FDA) as well as the European Medicines Agency (EMA),” a company official said.
He also pointed out the suit from the UFCW shows that Remicade is being marketed unfairly not only to its competitors but also to the patient organizations that use the drug.
Pfizer commented that the suit against J&J was to ensure patients and providers have access to important, lower-cost biosimilar medicines. However, the company did not go further, commenting that it could not comment on the litigation involving other parties.
Meanwhile, Janssen recently dropped the lawsuit filed against Samsung Bioepis in May for infringing on three of its patents. The dismissal of the entire suit was “with prejudice,” meaning that Janssen cannot bring the same allegations against Samsung Bioepis in any future lawsuits.
“Upon review of Samsung’s manufacturing information, we determined that their manufacturing processes do not infringe on the company’s patents,” a company spokesperson wrote. “We have therefore withdrawn our lawsuit.”