Food and Drug Administration approval of a biosimilar drug for cancer in March signals the arrival of a new class of treatment options for people battling serious and chronic illnesses like psoriasis and psoriatic arthritis.
But FDA approval of biosimilar drugs – drugs that are similar, but not exact replicas of biologics – also raises questions and concerns--how effective and safe will biosimilars be? Will they be more affordable than biologic drugs? Will doctors or insurance companies have final say on substituting a biosimilar for a biologic drug?
The issue of biosimilars is as complicated as the drugs they aim to mimic. Biologic drugs are derived from living human cells cultured in a laboratory. They are given by injection or infusion, and treat psoriasis and psoriatic arthritis by targeting specific parts of the immune system that cause the psoriatic inflammation. Because of the complexity, it’s not possible for a biosimilar to be an exact copy of a biologic.
In other words, that Remicade biosimilar the FDA is slated to review soon may be similar to Remicade, but it is by no means a generic version of the drug.
As a patient advocacy organization, the National Psoriasis Foundation supports the development of safe and effective treatment options, but emphasizes that the doctor-patient relationship should be at the core of all treatment decisions.
We recently invited Dr. Craig Leonardi, a dermatologist at Central Dermatology in St. Louis and a clinical assistant professor at St. Louis University, to answer patient-submitted questions about biosimilars for one of our free webcasts.
Leonardi explained how biosimilars are tested for safety and efficacy by using the concept of extrapolation:
Extrapolation is a concept where you might test your biosimilar drug in psoriasis, but then if it was proven to be similar and it was called a biosimilar, then the drug could be prescribed for not only psoriasis but psoriatic arthritis, for rheumatoid arthritis, for other disease states that were originally approved for use when using the reference molecule … A biosimilar etanercept (Enbrel) might be tested in psoriasis, found to be similar, but then it would be given the green light for treating rheumatoid arthritis patients. It’s an unsettling concept for many physicians and perhaps some patients.
Leonardi also discussed the cost of biosimilars. One viewer asked whether they will really be more affordable than biologics.
We have absolutely no idea … right now, as many of you know, there are generous patient assistance programs made by the manufacturers of the reference compounds. Enbrel and Humira, frequently patients get that for $5 a month. That price is achieved through patient assistance programs. The AbbVie patient assistance program would never be used to adjust the price of biosimilar Humira. And so something is going to have to happen at the pricing level, at the insurance company level too, to even the playing field, and I frankly have no idea about how that is going to happen. I’m sure it’s going to start out being a bit messy and then it will get cleaned up.
Listen to the full Q&A with Leonardi, as well as view his in-depth explanation of biosimilars below.
Several states across the country are considering legislation that will determine how biosimilars are prescribed and who—doctors or insurance companies—gets to decide when a biosimilar is substituted for a biologic. You can get involved in our efforts to support legislation that puts the doctor and patient relationship first by emailing [email protected].
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