Pfizer will certainly be happy with the FDA’s ruling today; Johnson & Johnson? Likely not so much.
Second approved biosimilar to pass the FDA’s desk
Firstly, a biosimilar is a distinction given to drugs that are grown in living cells that are similar to clinical effects derived from the original drug. Since we’re talking about pharmaceuticals, they aren’t terrifically different than legal generic drugs that contain the same chemicals as the original drug but are mixed in different quantities.
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The FDA rarely approves biosimilars but did today with Pfizer’s Inflectra, which it licensed from South Korean company Celltrion for U.S. distribution. This will surely come much to the chagrin of Johnson & Johnson the maker of Remicade which was the first of the two approved for the treatment of irritable bowel syndrome, Chrohn’s disease, rheumatoid arthritis and more.
Now that Inflectra has been approved, Pfizer will likely be able to market the very similar drug at a much lower cost than Remicade.
That does not mean Pfizer will be allowed to sell it immediately given the lawsuit that Johnson & Johnson had already filed in the event of the approval of Inflectra. While Pfizer has told both regulators and stockholders that it plans to introduce to the market, the lawsuit is clearly what they are speaking to when they say that sales will start soon but will be determined by “marketplace dynamics and intellectual property considerations.”
FDA speaks to the matter
“Biosimilars can provide access to important treatment options for patients who need them,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a press release explaining the administration’s approval. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”
Approval is one thing, getting past a lawsuit is another. Johnson & Johnson filed the suit last year against Celltrion claiming the South Korean company is in violation of six patents held by J&J for Remicade. Those patents don’t expire for over a decade so the suit matters quite a bit to Johnson and Johnson. That said, the single patent covering the makeup of Remicade expires in just two years.
The Affordable Care Act was meant to make the development of biosimilars easier, well, lawyers.
The two drugs, according to the FDA, are not interchangeable but as Johnson and Johnson points out the conditions both drugs are approved to treat are nearly identical in list form including: Crohn’s disease in adults and children, and adults with ulcerative colitis, rheumatoid arthritis, spinal and psoriatic arthritis among a few others.
Remicade is quite expensive and Celltrion knows this. They have approval for the drug in 71 countries but until today, not the United States. If allowed in the United States, Remicade sales will plunge given its similar make up and much lower cost.
“As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines,” HyoungKi Kim, chief executive officer of Celltrion, said in a press release. “Our experience with biosimilars outside the U.S. suggests that Inflectra provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the U.S”
Again, much to the chagrin of Johnson & Johnson.