Pricey drugs made cheaper?

Biosimilar. As both an adjective and as a noun, it describes something that during the next several years may save Americans with severe or chronic medical conditions significant money on some very expensive prescription drugs.

In March, the U.S. Food and Drug Administration approved the first of a group of drugs dubbed biosimilars, or nonbrand-name near-equivalents of biologic drugs. It’s called Zarxio, and it’s modeled on an existing brand-name drug used to boost white blood cell counts in people who are undergoing chemotherapy for cancer.

Zarxio is expected to cost less than its expensive, brand-name cousin. And although Zarxio so far is the only biosimilar to be granted FDA approval, it may herald a coming wave of other biosimilars to market which, it is hoped, can represent a financial godsend for patients who use them.

Most of the common drugs with which laymen are familiar — Lipitor, Viagra, numerous generic and brand name painkillers and antibiotics — are created by following, in effect, a chemical recipe “to produce an exact replica, if you will,” says Mark Decerbo, a doctor of pharmacy and associate professor of pharmacy practice at Roseman University of Health Sciences College of Pharmacy in Henderson.

Biologic drugs, in contrast, are produced from cell cultures, from living cells, Decerbo says.

“They can be produced from bacteria, they can be produced from yeast, Decerbo says. “So it’s an entirely different process, obviously, because it’s not really us who are producing them from the cookbook formula, it’s the bacteria or the yeast that are producing these.”

The relative simplicity of creating a drug by the cookbook-recipe approach led to the ability to create and bring to market identical, lower-cost generic versions of higher-priced brand-name drugs. However, even though biologics hit the U.S. market back during the ’80s, “no one gave thought to (producing) generics based on them because they’re so specialized,” Decerbo says.

Because of the lack of standardization inherent in using living organisms to manufacture biologic drugs, “no one thought it would even be possible to (manufacture a biologic) that would be even closely identical” to the original, he explains. “Our molecular (generic) medicines are exact copies. With biologics, there’s no such thing as an exact copy, and even the companies that make the brand-name biologics, processes still are always different a little bit from production cycle to production cycle.”

Another hurdle to creating what would be, in effect, a generic version of a brand-name biologic drug was that there was no federal licensing pathway to approve a drug that was similar, but not identical, to its name-brand cousin.

Then came passage of the federal Patient Protection and Affordable Care Act, which, through the Biologics Price Competition and Innovation Act, created a regulatory pathway for drugs that, the FDA says, are “highly similar” to “an already-approved biological product.”

Now, Decerbo says, a company that wishes to create a biosimilar version of a brand-name biologic drug must show that the new product is “highly similar in terms of structure” and that the biosimilar carries “no difference in efficacy and safety.”

And that led to the FDA’s groundbreaking approval of Zarxio, which, says Dr. James Sanchez, a medical oncologist with Comprehensive Cancer Centers of Nevada, helps to boost white blood cell counts in patients who are undergoing chemotherapy for cancer.

“One of the biggest negative side effects of chemotherapy treatment has always been that it (causes) a drop in white blood cell counts, and that’s the first line of defense against infection,” Sanchez says, and that can lead to “a significant number of hospitalizations after a course of chemotherapy.”

Zarxio and its brand-name predecessor “are designed to help stimulate the bone marrow to make a quicker recovery, so it reduces the time a person is immune-compromised and makes them stay healthy and on track with treatment,” Sanchez says.

Sanchez says he’s been practicing medicine for about 30 years and remembers the days before biologic drugs were available. Today, he says, “I’d say the vast majority of (cancer) patients are receiving some form of biologic, either as a supportive agent or as an actual specific treatment for their underlying cancer.”

Biologic drugs also are used in treating rheumatoid arthritis. Two common biologics, Humira and Enbrel, even have become network morning TV ad staples.

Dr. Mitchell Forman, a rheumatologist and dean of Touro University Nevada College of Osteopathic Medicine, says that while biologic drugs aren’t first-line treatment for rheumatoid arthritis, they can be “very effective” in “reducing the inflammation and the underlying autoimmune inflammatory process associated with rheumatoid arthritis.”

As useful and as effective as biologics can be, they do have a downside: Biologic drugs “are generally very, very expensive medications,” Forman says.

Forman estimates that treatment with a biologic drug — which typically is administered via injection or intravenously — can cost $1,000 to $2,000 monthly, and that the copayment alone for a biologic drug can mean $600 or $700 a month out of pocket for a patient.

“My patients tell me all the time, ‘I can’t afford to pay that kind of copay,’ ” Forman says. “Some of the pharmaceutical companies have patient assistance plans that provide (a) biologic free of charge to the patient, but you can’t rely on them.”

Just as the introduction of generic drugs offered consumers significant cost savings, Sanchez says it is hoped that the introduction of biosimilar drugs “will provide competition and, hopefully, lead to a decrease in (biologic drugs’) cost, because the costs are very high.”

Decerbo says there are not yet any solid estimates of how much patients, and the health care system, might save through the introduction of biosimilars. But, he notes, data from Europe — a form of Zarxio has been on the market there for several years — point to savings of about one-third over the cost of a brand-name biologic.

But don’t hold your breath. While a handful of other biosimilars are waiting in the wings, research, development, clinical trials and ultimate approval take time. Also, while they are expected to cost less than brand-name biologics, even biosimilars still will represent a hefty chunk of change for patients to pay.

However, the advent of biosimilars is, Sanchez says, good news for patients. Until now, the biosimilar debate has played out mostly behind the scenes, as a sort of inside baseball undertaking among medical professionals, pharmaceutical companies and regulators.

But, Sanchez says, “I think it needs to be played out in the social arena, because this is something that can benefit everyone.”

Contact reporter John Przybys at jprzybys@reviewjournal.com or 702-383-0280, or follow @JJPrzybys on Twitter.