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While FDA approved the second biosimilar drug to Enbrel, the success of the medication hinges on a pending lawsuit.
While FDA approved the second biosimilar drug to etanercept (Enbrel, Amgen) to treat rheumatoid arthritis (RA) and other inflammatory conditions, the success of the medication hinges on a pending lawsuit.
FDA cleared etanercept-ykro (Eticovo, Samsung Bioepis) after clearing another biosimilar-etanercept-szzs (Erelzi, Sandoz)-in 2016.
However, Erelzi has yet to come to market, since Amgen filed a patent infringement suit against Sandoz in 2017. The legal battle is ongoing.
“If Amgen prevails in the lawsuit against Sandoz, it could keep biosimilars off the market until 2029, meaning the latest biosimilar approval is of minimal near-term significance,” Jeremy Schafer, senior vice president and director of the Access Experience Team at Precision for Value, told FormularyWatch. “However, if Sandoz prevails and a launch occurs in the near future, the approval of a second biosimilar could begin to erode cost in the category.”
Once etanercept biosimilars enter the market, they will help drive down healthcare costs, agreed Mark Ginestro, a principal at KPMG Strategy.
“From what we’ve seen in other biosimilar launches, a lot of the savings come from stronger negotiation leverage that drives pricing down of existing players who want to maintain share. Biosimilar entrants do pick up share,” Ginestro told FormularyWatch.
However, in the RA market, there are very different uptake patterns for biosimilars, according to Ginestro, particularly with existing patients versus new RA patients. “It is a chronic condition and there is not a lot of motivation for switching away from something that is working,” he said.
Eticovo has already been approved in 38 countries, Samsung Bioepsis said in a statement.
In a 52-week phase 3 clinical study, which randomized 596 patients with rheumatoid arthritis across 70 sites in 10 countries, Eticovo demonstrated comparable safety and efficacy to Enbrel.
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