Next-gen meds require communication

Kenneth Fisher

Biologic medicines — complex molecules grown in living cells — are one of the best treatment options for patients suffering from serious conditions like rheumatoid arthritis, multiple sclerosis and cancer. Soon, copies of these medicines called “biosimilars” will bring new treatment options to these patients and their health care providers — potentially at lower cost. However, biosimilars also bring new challenges for our lawmakers.

In Michigan, policymakers are tackling an important issue surrounding the use of biologic medicines with House Bill 4812. This legislation may seem inconsequential to some, but for doctors serving at the front lines of medicine, it outlines important protocols regarding biosimilars that will help us to promote patient safety. Basically, HB 4812 ensures pharmacists communicate to prescribing physicians what medication was dispensed to the patient — biosimilar or biologic. Think of it as a proverbial “heads up” between pharmacists and physicians.

You might wonder why physicians want or need this information communicated to them in the first place —after all, aren’t biosimilars just copies of biologics? That’s the question that gets to the crux of this issue.

While so-called “generic” medicines are exact copies of relatively simpler chemical drugs, biosimilars are not identical to the product they are created to imitate. They are, as their name implies, merely similar. When a biosimilar is created, it is a new biologic product that has been reverse-engineered to mimic the therapeutic properties of the originator medicine. It is made from different biologic materials and through different manufacturing processes.

This distinction may seem like splitting hairs, but doctors who make regular use of biologic medicines can attest to the fact that it’s an important one. Seemingly minor differences between a biosimilar and its reference biologic can produce unexpected and potentially harmful effects in a patient. Given the serious and chronic nature of the conditions biologics are typically used to treat, it is critical that physicians always know precisely which medicine — biologic or biosimilar — the patient receives at the pharmacy. This helps us accurately assess patient response to a treatment, accurately attribute any adverse events to the correct medicine, and allows us to provide informed advice throughout the course of treatment.

Michigan took a critical step in this direction when House lawmakers approved HB 4812 earlier this month by a near-unanimous roll-call vote. It is now up to Senate policymakers to weigh this admittedly complex issue.

Dr. Kenneth Fisher is a nephrologist from

the Kalamazoo area.