Biosimilars have been in the news for the past couple of years, but it wasn’t until recently that the Food and Drug Administration (FDA) approved a rheumatoid arthritis biosimilar drug.
Developed by Celltrion, Inflectra is only the second biosimilar drug approved in the United States.
The first biosimilar, Zarxio, was approved last year.
What’s the Deal with Biosimilars?
Perhaps the terms knockoff or generic may hold some kind of negative connotation, but biosimilars are anything but negative in the eyes of many doctors and patients dealing with rheumatologic and inflammatory diseases.
In fact, biosimilars such as Inflectra offer a new, more affordable treatment option for patients who were having trouble getting Remicade covered due to its expense.
The cost of RA drugs are some of the priciest in the nation, so it’s no wonder that patients and insurance companies have been clamoring for cheaper options when it comes to managing this debilitating condition.
Biosimilars are nearly identical copies of the biotech drugs they are mimicking.
With a lower price tag and the same quality, biosimilars will likely become a go-to option for the treatment and management of RA.
A Tough Approval Road
The road to FDA-approval hasn’t been easily traveled for biosimilar manufacturers.
Biologic drug companies are unhappy with the appearance of biosimilars on the market. Before, they had little to no competition. They owned patents and there were no generic versions of these drugs available.
Now, as patents expire and biosimilar drugs start to pop up, the landscape of the biomedical industry will be changing.
While biosimilars aren’t technically the same as generics, they are still poised to take money from the pockets of the pharmaceutical companies that once had a practical monopoly on the industry.
That said, the biosimilar drugs could be a little more costly than once thought. And they aren’t on the market just yet.
In a statement to the press, Pfizer, which holds the U.S. marketing rights for Inflectra, said they are, “continuing with the preparation of our launch plans for 2016.”
However, the company added the exact timing would depend upon “marketplace dynamics and intellectual property considerations.”
It’s also worth noting that Inflectra is not literally an identical or exact copy of Remicade and the FDA didn’t technically approve it to be interchangeable with Remicade. This, among other licensing and formulary conditions, is part of what differentiates it from being a generic form of the drug.
Rays of Hope
Still, the emergence of any new drugs or treatments is a ray of hope for patients, who often try every medication available, only to have them not work.
In a press release, the American College of Rheumatology stated that, “The safe adoption of biosimilars into the U.S. marketplace remains a top priority for the American College of Rheumatology (ACR). Biologics are a lifeline for patients living with rheumatic disease, helping many to avoid pain, long-term disability, and life-threatening complications. Unfortunately, many of our patients struggle to afford these complex therapies due to their high cost.”
However, the patent on Remicade does not expire until 2018. With lawsuits claiming that Inflectra is infringing on intellectual property rights, patients may not see Inflectra made available for years to come. But, the FDA approval is, at least, a first step.
And patients needn’t worry about safety, according to a published press statement from the FDA.
“Biosimilars can provide access to important treatment options for patients who need them,” said Dr. Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research. “Patients and the healthcare community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”