A generic approach to biosimilar substitution won’t do

biosimilar imageBy Kyle Keeney

In Kentucky you don’t have to look far to find the positive impacts of health care innovation.

From preventative medicines to new cures, advances in medical technology have been the driving force behind significant improvements in patient health. But as new treatment options are introduced to the market, protecting patient safety has never been so important.

This year, the General Assembly is considering legislation that would establish a much-needed framework of regulations for biologics and biosimilars – breakthrough treatments that could help many people living with chronic diseases.

Unlike oral pills or tablets, which are made from chemically derived ingredients, biologics are complex treatments manufactured from living organisms – cells programmed to produce a desired therapeutic substance in a highly controlled, sterile environment.

While drug manufacturers are able to create chemically identical copies of pharmaceutical medicines such as oral pills – think generic versions of brand name drugs – the same isn’t true for biologics because they are made from living materials that cannot be perfectly duplicated.

Drug manufacturers can, however, create a version of a biologic that is so close to the original medicine it may be deemed a biosimilar. This could benefit many patients with chronic diseases, as biosimilars are expected to cost significantly less than biologics.

SB 134, in its originally intended form, would establish much-needed guidelines for substituting an interchangeable biosimilar to ensure patient safety. This includes ensuring that substitution would occur only when the FDA has designated a biosimilar as interchangeable; that the prescribing physician would be able to prevent substitution if he or she feels it is not in the patient’s best interest; that pharmacists would be required to communicate what product was dispensed with the prescribing physician; that the patient, or the patient’s authorized representative, would, at a minimum, be notified of the substitution; and that the pharmacist and the physician would keep records of the substitution.

Given the complex nature of biologics and the challenging medical conditions they treat, these are commonsense guidelines to ensure that doctors, patients and pharmacists are all informed about the medications that are prescribed and ultimately dispensed to the patient.

Biologic medicines are an important new tool in treating and curing disease. Biosimilars are also important for providing different and sometimes less expensive options for treatment.

But let’s be clear. Patient safety and ensuring physician involvement is far more important than helping the insurance company’s bottom line.

Legislators should pass SB 134 as it was originally intended. Common sense dictates that we make sure physicians are informed about what products their patients are using to treat their life threatening and chronic illnesses.

Kyle Keeney is the Founder and Executive Director of the Kentucky Life Sciences Council.