Johnson & Johnson (JNJ)’s Remicade earned close to $7 billion last year, making it by far the biggest drug in their portfolio, but the FDA has approved a new knockoff…which may finally start to shift the market dynamics toward greater competition with lower prices.

Written by John Carroll (ENDpts.com)

The FDA approval was unusual among the recent bio-similar 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.

The knockoff drug is dubbed Renflexis and comes from Samsung Bioepis, one of the big players in the bio-similars field. It arrives in the U.S. market close to a year after the EMA approved it for Europe.

JNJ has yet to feel much of an impact from the first Remicade bio-similar from Pfizer, Inc. (PFE), Inflectra (infliximab-dyyb), which was developed by Celltrion and then bagged by the pharma giant in its acquisition of Hospira…last fall. 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 & Co., Inc. (MRK) 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.

Novartis A G (NVS) CEO Joe Jimenez, who’s been fielding knockoffs through Sandoz, has predicted that bio-similar 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 U.S. 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 Inc. (BIIB) — has set its sights on the first wave of blockbuster bio-similars, with programs for Enbrel, Humira, Lantus, Avastin as well as Remicade.