Biologic medicines currently help millions of patients suffering from serious conditions like cancer, multiple sclerosis and rheumatoid arthritis. New medicines called biosimilars, which attempt to mimic the therapeutic properties of the original biologics, are becoming available. These will create new treatment options — and cost savings — for patients. But unlike generic versions of chemical drugs, biosimilars are not exact duplicates of their innovator drugs. Biologics are complex molecules grown within living cells, and an attempted copy can only be, as the term suggests – similar to its innovator drug, but never exactly the same.
This distinction is important, as doctors and pharmacists know, because even seemingly minor differences between two similar biologics can be the difference between helping a patient, or hurting them – sometimes severely – through unintended side effects such as unwanted immune responses.
Many states have prepared for biosimilars by passing legislation meant to ensure their safe prescribing and dispensing. More need to catch up, including New York, which has yet to adopt legislation addressing substitution of biologics at the pharmacy. Substitution is expected to bring cost savings for patients and the health care system, but policy must reflect that biosimilars are different from generics.
First, we need to ensure that only “interchangeable” biosimilars — those that the FDA has determined produce the same effects as the original product, without additional risks if a patient is switched between them — are ever substituted. While only one non-interchangeable biosimilar has been approved, FDA’a Dr. Janet Woodcock has predicted the approval of an interchangeable biosimilar by the end of 2016.
Even more important, we need to ensure clear and timely communication between pharmacists and physicians about the specific product received. Keeping accurate patient records and knowing what medicine patients actually receive is vital to accurately attributing adverse drug reactions, and tracking the long-term safety and efficacy of biologic medicines. This is especially important with biosimilars, which benefit from an abbreviated approval process. It also promotes manufacturer accountability for their products.
While communication between prescribers and pharmacists around substitution might seem intuitive, many states – including New York – don’t require it. Thus, legislatures across the country are passing laws reflecting the importance of this communication, and of recording substitutions, when dispensing biologics. In November of last year, our neighbors in New Jersey enacted such a law.
Legislators in Albany are now working extend these protections to New York’s patients by passing legislation that promotes transparency and communication between pharmacists, doctors and patients, so everyone knows which biologic is actually dispensed after one is prescribed.
The burden of educating legislators and urging them to act on this issue falls on the entire medical community, including pharmacists like me. I will continue educating my colleagues, doctors and the patients we serve about the importance of this issue. I hope New York legislators and my fellow pharmacists agree, and advocate accordingly.
Joe Bova, M.S., R.Ph, Director
Department of Continuing Education
Long Island University College of Pharmacy