Biological drugs are modern medical miracles. Derived from living organisms, this complex class of drugs — known as "biologics" — has proven astonishingly effective in treating a wide range of diseases, including rheumatoid arthritis, cancer, and a host of complex autoimmune disorders.
Thanks to the 2010 Patient Protection and Affordable Care Act, patients will soon have access to more affordable versions of these medicines. That legislation empowered the Food and Drug Administration to begin approving "biosimilars."
The impending availability of biosimilars is great news for patients. Like traditional generics, biosimilars tend to cost less than brand-name medicines.
However, because biologics are derived from living organisms, they come with some unique challenges. Unlike traditional generics, biosimilars aren't exactly identical to their brand-name counterparts. That's why these drugs are called "biosimilars."
Consequently, over a dozen state legislatures — from Pennsylvania to Texas to Oregon — are now considering legislation to establish commonsense guidelines governing biosimilar substitution. Quick action on these measures is critical, as the FDA has stated that it has no plans to issue any product-specific guidance to physicians or pharmacists prior to approving these drugs.
The charge for lawmakers is to strike the right balance between providing patients with access to these lower-cost, high-tech drugs while also keeping them protected from specific — though small — health risks.
Striking this balance is particularly important to my organization, which is the only national non-profit dedicated to fighting autoimmune disorders. There are several highly effective biologic drugs already on the market to treat prominent autoimmune conditions like rheumatoid arthritis, lupus, psoriasis, Crohn's disease, and multiple sclerosis.
The 50 million Americans suffering from autoimmune conditions would benefit tremendously from gaining access to low-cost biosimilar treatments.
For our constituents, the ideal bill establishes both a clear channel for patients to access biosimilars and some commonsense consumer safeguards.
These protections should not be oppressive. Any biosimilar stamped as interchangeable by the FDA will almost certainly be safe. The agency is well-equipped to make this important scientific determination. And patients should not be blocked from using FDA-approved biosimilars.
But the basic scientific facts surrounding biosimilars call for some specific patient protections — many of which are already in place for traditional generic medicines.
For starters, pharmacies should only be allowed to substitute in a biosimilar if it's approved as interchangeable by the FDA. And when pharmacists substitute a biosimilar, they should inform both the patient and the prescriber of the switch in a timely fashion.
Pharmacies and attending physicians should also keep detailed records of all biosimilar substitutions. In the rare event of an adverse reaction, healthcare providers could use these records to quickly identify the cause of the reaction and adjust treatment accordingly.
Finally, doctors should retain the ultimate authority to prescribe a biologic to be "dispensed as written," meaning no substitution. Physicians already have this power for traditional chemical drugs. This is important, as autoimmune patients can have sensitivities known only to their doctor.
Contrary to what opponents of this legislation have said, none of these rules block biosimilars from the market.
Fortunately, all the state-level biosimilar bills are grounded in these scientific realities and include all or most of these protections. That is why a diverse and expanding group of patients, healthcare providers, and community organizations have called for state legislators to pass these measures. Doing so would protect against the minor health risks of biosimilars while establishing a clear channel for patients to access these lifesaving medicines.