Merck’s Intensely Contested Bid To Market Generic Version Of J&J’s Baby Boomer Blockbuster

An advisory panel to the U.S. Food and Drug Administration on Friday recommended approval of an application by Merck to market a generic version of Johnson & Johnson’s immune-boosting drug for the treatment of sepsis.

The unanimous vote in favor of the request comes as a surprise because the panel has previously recommended approving the generic version of Remicade, Johnson & Johnson’s best-selling drug.

Remicade earned $7.3 billion for J&J in the first nine months of this year. That means Merck’s application would not affect Johnson & Johnson’s performance in the domestic market.

In another surprise, the panel recommended approval of a generic version of the arthritis drug Remicade, with one of the advisers concluding that generic competition does not necessarily mean it would be free of health risks.

“Uncertainty continues as we approach Merck’s request for approval to market a generic version of Remicade in the U.S.,” a spokesman for J&J said.

In an email, Merck said it was pleased with the panel’s vote on the application.

“We have worked collaboratively with J&J on discussions of the potential emergence of a generic, a biosimilar, of Remicade, and are proud of our achievement in working with them to enhance patient access to the drug by respecting a patient’s ability to remain on therapy during the REMS process,” a Merck spokesman said. “When it is fully cleared by the FDA, we expect a competitive biosimilar market.”

J&J has been battling recent attempts by generic companies to market versions of Remicade for a while. Earlier this year, a company called Novartis Invent acquired an application from China’s Fosun to market a generic version of Remicade in the U.S.

Earlier this month, while voting to recommend against the approval of a generic version of Remicade, the committee of advisers to the FDA said the public should have three months to remain on Remicade if they were experiencing severe or persistent pain.

The committee also said an authorized generic or biosimilar that replaces Remicade should also allow patients to continue taking Remicade during a biosimilar’s launch.

“The importance of making sure patients are not forced to make significant trade-offs in treatment should not be underestimated,” said Harvey Nowick, a professor of medicine and director of the Johns Hopkins Mayo Clinic Center for Bioethics. “This is truly a case of ‘what are you protecting patients from, making them unnecessarily uncomfortable, leaving them on another type of therapy that they can tolerate just fine?’”

The panel, held at the FDA’s headquarters in Silver Spring, Md., also voted unanimously to recommend approval of a generic version of the antidepressant Zoloft that belongs to a class of drug called SSRIs.

Zoloft was marketed by Pfizer until its patent expired in April 2014. Bayer has been marketing an authorized generic since 2016.

In earlier votes, the panel expressed concerns about the potential adverse health effects and pill discontinuation with a generic version of the drug.

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