Update law for new meds

By James C. Greenwood

As a former Pennsylvania state legislator and member of Congress, I know well the time, patience, and careful deliberation required to advance legislation on complex issues. A good example of this process is playing out now in Harrisburg as lawmakers consider legislation that will expand patient access to lower-cost biologic medicines called biosimilars and interchangeable biologics.

The Food and Drug Administration (FDA) has the authority to approve and regulate these new types of medicines, which should be lower-cost alternatives to the innovator biologic medicines currently on the market. These new biosimilars and interchangeable biologics will provide patients with additional treatment options that are safe and effective. Biosimilars are already used in Europe to treat conditions such as cancer, kidney failure, arthritis, and numerous rare disorders.

Unlike chemically derived pharmaceuticals, biologic medicines originate from living organisms that are derived from cell cultures and manufactured through a highly complex process. This is an important distinction. These new biosimilar medicines will be created from different cell lines than the innovator biologic, and manufactured through separate processes that will make them similar, and in some cases deemed interchangeable, by the FDA, but nonetheless different from the brand-named innovator medicines they seek to replicate. So while they will fill a comparable place in the prescription drug market to generic medicines, they are not the same as generics and must be treated differently due to their complex structure.

Many biologic medicines are administered by health-care practitioners in a hospital or an infusion center due to their complexity and the seriousness of the conditions they treat. There are, however, a growing number of new biologic medicines that are self-administered by the patient at home and dispensed at local retail pharmacies.

In order for pharmacists to substitute these lower-cost biologics, lawmakers in Harrisburg must first update laws that determine how medicines are dispensed. Legislation to address this issue - Senate Bill 405 and House Bill 746 - would allow for pharmacist substitution of biologics deemed interchangeable by the FDA, ensuring that patients have such lower-cost options available to them.

These bills require a pharmacist to communicate with the patient's physician when substitution of a biologic product occurs. Because even biologics deemed interchangeable are not exactly like the innovator biologics they are trying to replicate, it is essential that a patient's physician know precisely what drugs are being administered.

Pennsylvania lawmakers need to look no further than our neighboring state of Delaware for inspiration. Recently, Gov. Jack Markell signed similar legislation, following unanimous support in both the Senate and House.

Interchangeable biologics provide additional options for healing debilitating diseases. Pennsylvania lawmakers - and legislators around the country - should do their part to make certain that, when these options become available, nothing prevents patients from obtaining them.