- The Federal Trade Commission is investigating whether a Johnson & Johnson subsidiary violated antitrust laws with the contracting practices used for its anti-inflammation drug Remicade.
- J&J disclosed the legal challenge Monday in a regulatory filing, saying the FTC issued a Civil Investigative Demand in June. The pharma gave no further details of the FTC's inquiry and did not respond Tuesday to a request for comment.
- Remicade is a long-time blockbuster biologic for J&J, initially approved in the U.S. in 1998. While Pfizer launched a biosimilar in 2016, uptake has been minimal with recent prescription statistics showing J&J has kept more than 90% of the market.
While the FTC is in the early stages of a civil investigation, Pfizer has battled with J&J on Remicade (infliximab) for a couple years now. Failing to gain market share with its lower-priced biosimilar, Pfizer filed an antitrust complaint against Janssen in 2017.
In that big pharma fight, Pfizer accused J&J's contracts of being anti-competitive, saying the deals required insurers to deny access to copycat versions of Remicade in order to get access to the branded biologic. J&J also bundled Remicade's rebates in with other products, Pfizer claims.
Pfizer described reimbursement coverage as "mixed overall" for its copycat, named Inflectra (infliximab-dyyb), in a financial filing from earlier this year.
"While we achieved 100% Medicare coverage, in the face of exclusionary conduct by J&J, we have experienced access challenges among commercial payers where our lower priced product has not received access at parity to the innovator product," the big pharma wrote in that filing.
Both companies' legal teams are building their cases through the discovery process, expected to last into 2020.
Though branded Remicade still holds most of the market share, competition has eaten away at sales. The drug brought in $5.3 billion in 2018, down from $6.3 billion and $7.0 billion in the two prior years.
J&J posted $2.2 billion in Remicade sales for the first half of 2019, on pace to reach $3.2 billion for the year, according to SVB Leerink analyst Geoffrey Porges.
Porges noted the sales erosion has been slower than expected, and added it could boost expectations for other blockbuster biologics facing biosimilars in the coming years, particularly AbbVie's Humira (adalimumab) and Amgen's Enbrel (etanercept).
Bernstein's Ronny Gal has been more direct in his assessment of the market. In a research note this month, he called Remicade "essentially a failed market" for biosimilars, citing prescription data for the month of May showing J&J still holds a 91% share.
By contrast, Remicade biosimilars account for more than half of the market in Europe, where broader use of the copycat biologics has progressed much faster than in the U.S.