Concerns about biosimilar drugs seep to the surface in the rheumatoid arthritis (RA) community as the first biosimilar is approved.
Earlier this month, the Food and Drug Administration (FDA) approved Zarxio, which is produced by Sandoz, as the first non-brand name version of a biosimilar drug.
Zarxio is used to prevent infection in cancer patients or other patients receiving chemotherapy. It is similar to Amgen’s Neupogen.
“Biosimilars will provide access to important therapies for patients who need them,” Dr. Margaret A. Hamburg, the commissioner of the FDA, said in a statement.
A biosimilar drug is just what the name sounds like: a drug that behaves similarly to a biologic, producing similar results without any known level of increased risk.
So far, at least a few patients are somewhat skeptical.
Jenna Donnelly of Pittsburgh, Pennsylvania, has tried almost every biologic drug on the market to manage her RA. She said, “I would be willing to try a biosimilar in the future if they thought it would work, but I don’t know if it would make any difference for me since I’ve tried the biologics.”
“I worry about the safety with biosimilar medications that could come out for RA,” added BethAnn McGill of Collegeville, Pennsylvania. “Biologics themselves can be dangerous and are already genetically engineered substances. To then try to mimic that type of drug and cheapen the quality or engineer it even further is a little worrisome to me, especially because I try to utilize as many natural methods of treating my RA and lupus as possible.”
Medical Experts Have Some Concerns Too
The main areas of concern in the medical field are access and affordability for patients, as well as safety and transparency in prescribing.
The American College of Rheumatology (ACR) has posted a position statement on its website, expressing those concerns.
“As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high cost and patients being unable to afford them,” said ACR President E. William St. Clair, MD, FACR, in a press release. “We agree that less expensive biologic therapies are needed and recognize that biosimilars provide an opportunity to reduce treatment costs.”
However, St. Clair added that close monitoring of possible differences in the safety and efficacy of biosimilars and interchangeable biologics is needed as they enter the market.
It’s uncertain whether patients will respond to these drugs the same way they would to an original biologic, he added. That’s because biologics are sensitive to manufacturing changes.
“Even minor differences in a biosimilar’s molecular structure, purity or other chemical properties could change the way a patient responds to the drug,” St. Clair stated.
He said his organization will continue to follow the various issues surrounding the distribution, monitoring, and reimbursement of biosimilars as state and federal policies emerge.
“Ensuring patients have easy access to affordable treatment options and rheumatology care continues to be a high priority for us,” St. Clair stated.
Main areas of concern from the ACR, which is comprised of more than 9,400 rheumatologists and rheumatology professionals worldwide, include the need for clinical trials to ensure safety and efficacy, as well as the need for a policy stating that only physicians can prescribe a biosimilar.
What Is a Biosimilar Anyway?
According to the FDA, “A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.”
The reference products mentioned are biologics. Biologic drugs, also known by the FDA as biological products or biopharmaceuticals, have been around since the late ‘90s.
“A ‘biologic’ drug copies the effects of substances naturally made by your body's immune system. Biologic agents are genetically engineered drugs – meaning that human genes that normally guide the production of these natural human immune proteins (i.e., an antibody to TNF) are used in non-human cell cultures to produce large amounts of a biologic drug. These drugs are given to lessen inflammation by interfering with biologic substances that cause or worsen inflammation. These new biologic agents can specifically affect some of the abnormalities of the immune system that lead to the joint inflammation and other abnormalities seen in rheumatoid arthritis and so help treat its symptoms,” according to the ACR website.
The industry for these drugs is expected to grow quickly … and soon.
Express Scripts estimates biologics make up for 40 percent of prescription drug spending in the United States, even though only 2 percent of the population uses biologics. By 2018, they may account for more than half of all prescription drug costs. The National Center for Policy Analysis says that drug spending for all adults on the top five therapeutic drug classes was $147 billion in 2011, accounting for about half of all prescription drugs purchased by Americans. Most of these drugs are for chronic conditions.