Article
Author(s):
Results of the case could alter the future of the biosimilar marketplace.
Pfizer filed suit against Johnson & Johnson (J&J) on Wednesday for allegedly using anticompetitive practices to prevent less expensive versions of its rheumatoid arthritis (RA) drug to thrive in the budding biosimilar market.
J&J has sold the injectable biologic Remicade for nearly 2 decades, generating $4.8 billion in US sales last year alone. This injectable biologic drug is widely used to treat RA, Crohn’s disease, and other inflammatory disorders, according to the Chicago Tribune.
Pfizer’s Inflectra was the second biosimilar to receive FDA approval.
If Pfizer wins the case against J&J, it could pave a new path that would discourage brand name companies from cutting deals with insurers to limit competition in the biosimilar marketplace, according to the Chicago Tribune.
However, if J&J comes out on top it could continue to fuel strategies that thwart competition, according to the article.
“This is the first lawsuit that is challenging anti-competitive behavior in the biologics industry, and that is very important because this is the wave of the future—–this is where a lot of the innovation is taking place today,” Michael Carrier, law professor at Rutgers Law School, told the Chicago Tribune. “It really is an uncharted path, in terms of what competition should look like going forward.”
The lawsuit alleges J&J entered anti-competitive, exclusionary contracts with insurers, hospitals, and clinics, which blocked 70% of commercially insured patients from accessing their drug. Furthermore, Pfizer claims the contracts coerced insurers into not covering Inflectra by threatening to withhold rebates, the Tribune reported.
Although Pfizer said it offered discounts and rebates at as much as 40% off the list price, the company said J&J continues to have 96% of the market, according to the Tribune.
“This is, in our view, a bellwether case—–and what we are seeking is for J&J to refrain from using these sorts of exclusionary contracting arrangements with insurers and providers,” Lauren Chenoweth, deputy general counsel at Pfizer, told the Chicago Tribune. “Most importantly, we want to create an open playing field for biosimilars…to bring these drugs to a broader group of patients, at a better price.”
J&J issued a statement dismissing the lawsuit saying it had no merit.
“We are effectively competing on value and price, and to date Pfizer has failed to demonstrate sufficient value to patients, providers, payers, and employers,” said Scott White, president of Janssen Biotech, as reported by the Chicago Tribune. “Competition is bringing down the overall cost of Remicade, and will continue to bring down costs in the future.”
Remicade is priced at approximately $26,000 per year, whereas Inflectra is approximately $21,000. The Chicago Tribune noted the prices do not reflect rebates provided by manufacturers.
FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a