The Biosimilars Battle Heats Up

Pharmacy Times, March 2015 Central Nervous System, Volume 81, Issue 3

Could proponents of this legislation be more interested in protecting market share in the name of patient safety?

Throughout my career, I have appreciated the pharmaceutical industry’s contributions toward improving health. Because of the industry’s efforts, we now have drug therapy for previously untreatable diseases and conditions. New dosage forms and improved drug delivery systems make existing treatments easier for both patients and caregivers to administer. In addition, new drugs often achieve better treatment outcomes than previous therapies.

I accept the fact that drug discovery can be an expensive process. Considerable costs are associated with obtaining approval to market a new drug, dosage form, or delivery system. These costs need to be covered, resulting in new drug products that can seem expensive. Although I have no problem with companies making a profit, and I believe that our drug development system has worked well, in general, how much profit they should make is debatable. The marketplace seems to deal with the few abuses that occur, but regulatory reform has sometimes been necessary.

Early in my career, brand name pharmaceutical companies often made disparaging comments about the quality of generic drugs. Allowing pharmacists to dispense a generic product when a brand name product is prescribed was a hard-fought victory for our profession. The required state-level victories have benefited not only pharmacy but especially patients and payers. According to a RAND study published in 2014, the use of generic drugs saved close to $44.2 billion in prescription drug costs over the course of 10 years.

Now another controversy is heating up: the battle over biosimilars dispensing. As the FDA gets ready to approve the first biosimilar drug in the United States, state-level efforts are under way to make it difficult for pharmacists to substitute a biosimilar product for the reference product. The proposed legislation would establish special notification or communication requirements between dispensers and prescribers when a biologic or biosimilar product is dispensed.

Could proponents of this legislation be more interested in protecting market share in the name of patient safety? You can make that judgment yourself. Here’s what I think: the FDA will do everything in its power to ensure that any biosimilar put on the US market will be safe and interchangeable with the reference product. If the products are not interchangeable, that will be noted. The first biosimilar that might be introduced is a substitute product for Neupogen (filgrastim). This biosimilar is already on the market in more than 40 countries, and the manufacturer claims that it holds more than 50% of biosimilar approvals in Australia, Canada, Japan, and European countries. That this product would not be safe for US patients seems unreasonable.

While new biologic drugs can drastically improve patients’ quality of life, they can be very expensive, making them difficult for patients to afford. Thus, we need a way to promote access to affordable biosimilar medications after the innovator company’s patent expires.

The suggestion that biosimilar drugs warrant special control compared with traditional, small-molecule drugs is out of step with experiences in other countries. It seems premature to implement state legislation to hinder substitution with biosimilar products before they reach the market and evidence surfaces that biosimilars are causing problems. As we do with generic drugs, let’s trust pharmacists to make the right decision. After all, patients rank us as one of the most trusted professionals.

Mr. Eckel is professor emeritus at the Eshelman School of Pharmacy, University of North Carolina at Chapel Hill. He is emeritus executive director of the North Carolina Association of Pharmacists. A lifelong advocate for the profession of pharmacy, Mr. Eckel has lectured on pharmacy issues and trends in all 50 states and has traveled to 6 continents to promote and educate audiences on the role of the pharmacist.