About psoriasis > Treatments
Biosimilars: They're coming (maybe)
What it might mean for you
By Debra Gordon
For the past eight years, Sacramento, Calif., resident Mark McGraw has been able to control his psoriatic arthritis thanks to biologic drugs, first with Enbrel, then with Humira. McGraw, diagnosed with psoriasis 25 years ago, knows he's lucky. Not just because of the drugs, but because his health insurance covers most of the $22,600 annual cost. Combined with the manufacturer's copay assistance program, that means he pays just $10 a month.
McGraw, who is in pharmaceutical sales, has health insurance through his employer. If he somehow would lose his job, he says, he would also lose his insurance. And that, he says, could put Humira and other biologic drugs out of his financial reach.
So McGraw has more than a passing interest in the current debate over biosimilars, the "generic" version of biologic drugs, which have revolutionized the treatment of autoimmune conditions such as psoriasis, psoriatic arthritis, rheumatoid arthritis and multiple sclerosis, as well as cancer. "If I lost my coverage it would be a very big concern," he says. If biosimilars can save him money, he would be very interested, he adds.
McGraw may have to wait a while to find out.
Although the path to biosimilars, also called "follow-on biologics," was cleared with the passage of the Affordable Care Act in 2010, as of mid-January, the U.S. Food and Drug Administration (FDA) had yet to issue guidelines detailing the level of testing and oversight required for their approval. Nor had the agency clarified just how similar the follow-on products should be to the parent drug. Until that happens, the entire field of biosimilars in the U.S. is on hold.
Safety, effectiveness and cost: A balancing act
The controversy over biosimilars has to do with the complexity of biologic drugs, such as Enbrel and Humira, which Mark McGraw has used, compared to a medication such as methotrexate.
Making an exact duplicate of methotrexate is like making a chemical cake: You follow the recipe for the original drug, tweaking inactive ingredients just a bit to avoid copyright infringement. But biologic drugs are made from living cells, so reproducing them is much more challenging and unpredictable.
That unpredictability, notes St. Louis dermatologist Dr. Craig Leonardi—a member of the International Psoriasis Council and co-author of an article about biosimilars for the Journal of the American Academy of Dermatology—raises concerns about how well a biosimilar drug will work and how safe it will be.
Even a small change in the manufacturing process can affect the safety and effectiveness of a biologic, possibly triggering serious side effects, says Leonardi, a former member of the National Psoriasis Foundation Medical Board.
Most experts agree it will be very difficult to guarantee that a biosimilar drug will work the same in your body as the original drug, at least without extensive clinical trials. How extensive those tests should be is the crux of the biosimilars debate.
Clinical trials: Yes or no?
The makers of biologics know that biosimilars are coming. In fact, several, including Amgen and Merck, are gearing up to produce biosimilars of competitor products themselves. "We have over 30 years of experience developing biologics," explains Dr. Thomas Felix, scientific affairs director at Amgen, based in Thousand Oaks, Calif. "We believe we can put a lot of that experience to work developing biosimilars."
Nonetheless, he expresses similar concerns regarding the effectiveness and safety of biosimilars as the International Psoriasis Council's Leonardi. "In the generic world," Felix says, "you just prove that your active drug substance is the same [as the branded drug]." When you put it into the body, "It maintains the same levels with a certain range of acceptability for a generic copy." But you can't do that with a biologic, he explains. "If you can't prove that the biologic is exactly the same, then you're already missing one part of the equation for the generic." Even the smallest difference, he notes, can lead to variation in efficacy and safety for a product.
Patient advocates are also concerned about biosimilars, despite the appeal of lower prices. Several testified before the FDA in 2010 and the National Psoriasis Foundation submitted written testimony.
Their message: Biologics are complex drugs that require stringent manufacturing processes to avoid triggering immune reactions or potentially fatal side effects. Therefore, they urged the FDA not to waive the requirement for clinical studies of biosimilars, nor rely on animal studies as part of the approval process, since drugs often behave differently in animals than in humans. They also called for extensive oversight of the drugs after they are approved so any problems can be identified early.
Some generic pharmaceutical manufacturers have a different take on biosimilars. In 2010, Dr. Rasmus Rojkjaer, who heads biologic research and development for Mylan Inc., one of the largest generic drug manufacturers in the world, testified before the FDA on behalf of the Generic Pharmaceutical Association (GPhA), which represents more than 100 generic manufacturers and distributors. He termed the follow-on biologics "biogenerics," suggesting that they are the "key to lowering pharmaceutical costs over the next several decades, while increasing patient access."
Rojkjaer argued, and the Generic Pharmaceutical Association later reiterated in written comments to the FDA, that large-scale clinical trials aren't needed because the FDA already has extensive experience with biologics. When biologic manufacturers make changes to their manufacturing process—such as moving to a new facility, substituting an ingredient or changing the cells in which the drugs are grown—the FDA rarely requires significant clinical testing. The same guidelines, the pharmaceutical association argued, should be applied to biosimilar drugs, with any decision about clinical testing made on a case-by-case basis.
The FDA was expected to issue final guidelines in late 2011, but had not yet issued them by mid- January. The first biosimilar is expected to reach the U.S. market in 2014.
You may also be interested in:
Debra Gordon, M.S., is a medical writer based in Williamsburg, Va. Her Web page is www.debragordon.com.
This article originally appeared in
Psoriasis Advance: Winter 2012