J&J faces its second rival Remicade knockoff as FDA gives Merck a shot at a $7B franchise

The FDA has approved a new knockoff of J&J’s top earning drug Remicade, which may finally start to shift the market dynamics toward greater competition with lower prices.

This new one is dubbed Renflexis and comes from Samsung Bioepis, one of the big players in the biosimilars field. And it arrives in the US market close to a year after the EMA approved it for Europe.

J&J’s Remicade earned close to $7 billion last year, making this by far its biggest drug in the portfolio. And as J&J noted a few days ago during its Q1 call with analysts, the pharma giant has yet to feel much of an impact from the first Remicade biosimilar from Pfizer, Inflectra (infliximab-dyyb), which was developed by Celltrion and then bagged by the pharma giant in its acquisition of Hospira. That was approved last fall.

Now Merck will pick up the commercialization work of this second knockoff as J&J enters a new stage in defending the huge franchise. Ironically, Merck will now market Remicade in Europe, while competing with it in the US.

One reason why physicians may be sticking with the branded Remicade is that Pfizer offered only a 15% discount on their drug. We’ll see if Merck decides to be more aggressive in entering the new showdown with two major league rivals. But it will wait to the launch before it reveals the discount price.

Joe Jimenez. Novartis

Novartis CEO Joe Jimenez, who’s been fielding knockoffs through Sandoz, has predicted that biosimilar discounts will eventually reach 75%, though the market has a long way to go before it reaches the bargain basement.

These launches come after J&J had vowed to fight to the last attorney in their legal battle to protect the US Remicade franchise, but a judge ruled against the pharma giant last summer, clearing a path for the competition.

Like a number of other players in the field, Samsung Bioepis — closely allied with Biogen — has set its sights on the first wave of blockbuster biosimilars, with programs for Enbrel, Humira, Lantus, Avastin as well as Remicade.

This was unusual among the recent biosimilar approvals as it came without an FDA expert panel review, signaling that the agency is becoming increasingly comfortable in rolling out new OKs for this class of drugs.

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