Patients with severe chronic disease, are eager to gain access to a new class of medications known as “biosimilars,” which are less expensive imitations of “biologic” medications that have proven highly effective at treating a wide range of debilitating diseases including rheumatoid arthritis, multiple sclerosis, many types of cancer, psoriasis and lupus, among others.
Right now, the Colorado statehouse is considering a bill that would create a streamlined pathway for patients to obtain these cutting-edge biosimilars. This legislation establishes some wise patient protections and ensures state residents will have access to these promising therapies for decades to come.
Biologics are complex drugs derived from living organisms. Biosimilars are similar to, but not the same as, the existing biologic drugs. The bill currently before the Colorado statehouse would help patients access these new therapies while accounting for the unique health concerns associated with biologics and biosimilars.
Most people don’t think twice about swapping out a traditional brand name drug for a generic. But exchanging one biologic drug for another is a different matter. Among conventional pharmaceuticals, the active ingredient in generic drugs is chemically identical to the brand name. But biologic drugs are made from living things, such as cells, bacteria, yeast or animal products. As a result, biologics are much more complex than conventional pharmaceuticals and are produced through more complicated procedures.
Biologic drugs can’t easily be replicated by anyone other than the company that originally developed the drug. Another manufacturer can, at best, produce something biologically similar.
In most cases, one biosimilar drug can be swapped for another without affecting treatment. But biosimilars are not actually identical to the biologic they’re based on. In some rare case, they can elicit different medical reactions. That’s why any legislation governing the prescription of biosimilar drugs must contain four specific patient safeguards.
First, pharmacists should only be able to exchange a biologic with its biosimilar if the Food and Drug Administration has deemed the two drugs safely interchangeable.
Second, patients must be advised when they are getting a biosimilar.
Third, the prescribing physician must be informed that a biosimilar substitution has been made so that he or she can properly monitor the treatment and track any adverse reaction as well as therapeutic success
Finally, doctors and pharmacists must keep records on biosimilar drug prescriptions for at least five years. That’s because adverse reactions to biologics may not appear until as late as a year after a patient has begun taking them.
Insurance companies and healthcare providers will soon start structuring their plans to favor cheaper biosimilar alternatives where they exist, which makes sense. Only with all the information available can patients and physicians make a fully informed decision. But it’s also essential that patients be made aware of what’s happening, and that doctors are informed if a pharmacist swaps medicines.
The Global Healthy Living Foundation is an organization representing patients with chronic conditions and we are pleased to support Colorado’s biosimilar bill because it includes all four of these safeguards. Local patients will have their health protected whenever a biosimilar is swapped in for a prescribed biologic.
As patient advocates, this is paramount to us because safety is our top priority in the health care process. Legislators, health care providers and the patients who will receive these treatments can rest assured that this legislation creates a process by which substitution for biosimilars the FDA deems safely interchangeable can occur. These common-sense procedures improve safety with the promise to decrease cost.
Lawmakers should pass this important legislation as soon as possible.
Seth Ginsberg is the President of the Global Healthy Living Foundation.