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Why Are Biologic Drugs So Costly? – Courtesy (US News)
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Physician with Hypodermic Needle.

Finding out you have a chronic condition is one thing, but the real blow for many is discovering how expensive the biologic medication to treat the condition is. For some complex diseases, it’s a double-edged sword: Scientific advancements have given us a way to treat these diseases, but that comes at an extremely high cost.

And yet most patients who need biologics have few options that work as well as these treatments, which can cost more than $45,000 per year. To choose a cheaper drug option is often to choose a drug that just isn’t as effective.

Still, the cost of these medications is extreme and, for many, unaffordable. According to pharmacy benefits giant Express Scripts, even though only 2 percent of the population uses biologic drugs, biologics account for 40 percent of prescription drug spending in the U.S.

What’s a Biologic?

Some of the most confounding diseases, including cancer and autoimmune disorders such as multiple sclerosis and Crohn’s disease, are best treated with biologics. These drugs usually come as an injectable or in a solution to be administered intravenously by a nurse or other medical staff. However, vaccines, gene therapies, insulin and plasma treatments are also types of biologic drugs.

Most drugs are made through chemical processes in a lab – those are sometimes called small-molecule drugs. The active ingredients of such drugs are typically easier to produce.

Biologic drugs, rather than being synthesized from other compounds, are generally made using human or animal proteins. At the molecular level, they’re usually larger and much more complex than regular drugs. Such complex molecules are typically too expensive and difficult to create in a lab from non-animal building blocks.

The Monoclonal Antibody

Even though vaccines and insulin are also biologics, the most expensive type of biologic drug is called a monoclonal antibody. These are drugs such as Humira or Enbrel for rheumatoid arthritis andpsoriasis, and Tysabri for multiple sclerosis and Crohn’s disease.

First released in 1986 for the treatment of cancer, monoclonal antibodies are the most rapidly growing type of biologic drug. That’s because they are extremely targeted therapies that block specific interactions in the immune system, which regular drugs can’t do.

Monoclonal antibodies are large proteins that are produced by clones of the same living cell, normally from a rodent’s spleen. When these proteins enter the bloodstream, they’re able to attach to only a few types of cells, which attach to the protein like a puzzle piece. This is called a lock-and-key mechanism. Many cancer cells grow by the same mechanisms as other diseases, so biologics that were originally developed for cancer are now being tested to treat autoimmune disorders.

The Generics Problem

Biologics, a class of drugs that brings hope to those with few other alternatives, are also a class of drugs with no generic options. Strictly speaking, there’s no such thing as a generic biologic because the term “generic” only applies to small-molecule drugs made by traditional chemical processes. In generic medications, the active ingredients are identical molecules to the brand name drug, but this can’t be the case when a living cell produces the drug.

The equivalents to biological drugs are called biosimilars. The protein in a biosimilar might be slightly different than the original biological product, but it has the same lock-and-key shape. As such, a biosimilar interacts the same way the reference medicine does and produces the same results.

Currently there are no biosimilars on the market in the U.S., even though about a dozen biosimilars have been tested and approved all over the world. This is because small-molecule drugs and biologics are approved under separate laws. Before 2010, there was no provision for biosimilars in the Public Health Service Act; the law was amended to allow for biosimilars under the Affordable Care Act.

A Changing Landscape

Nearly five years after the ACA was passed, the Food and Drug Administration has recommended approval for the first biosimilar on the U.S. market, a leukemia drug. The biological drug it can replace is called Neupogen, which costs about $3,000 for 10 injections. The biosimilar, to be called Zarxio, could be sold for more than $1,000 less, according to the Rand Corp., a health care research organization.

But Zarxio is only the beginning. Rand researchers predict $44 billion in savings due to the approval of biosimilars over the next 10 years. Express Scripts is even more optimistic. Their researchers predict that if the 11 most likely biosimilars were to come to market over the 10 years, health care payers such as you or your insurance company could save $250 billion over 10 years.

But even if all biologic drugs had biosimilars available, they’d still be expensive for patients. It’s just not cheap to produce medicine from living cells with today’s technology. Still, these medications often save lives and, in time, costs may go down. Until then, some patients will be getting a less expensive option for their treatment very soon.

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