Safety First: Commonsense Rules for New Medicine

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July 15, 2014

Americans are blessed to have exciting, relatively new, medicines called “biologics” that can treat, cure or help manage devastating diseases like diabetes, cancer, HIV/AIDS, multiple sclerosis (MS), autoimmune diseases like rheumatoid arthritis, as well as heart attacks and strokes. For older Americans, these are truly “miracle” drugs that extend and enhance our lives. These are also expensive drugs, developed after years of costly research and many, many failures on the long road to success. As we all thankfully benefit from cutting-edge biologics, we also search for ways to reduce the costs.

One of the most promising ways to provide greater access to these powerful biologics and achieve some savings is the development of “biosimilars,” drugs that are similar to the original or “reference” biologics. Please note that they are “similar,” not exact copies, and not generic as are some “small-molecule” drugs that we are familiar with today. These are not the simple compound pills that we are used to, but rather complex compounds made from living organisms. Biosimilars can never be exactly the same drugs as the original biologics, which is especially important considering the possible adverse reaction each patient’s immune system may have to the biosimilar. That’s why patient advocates, and the U.S. Food and Drug Administration (FDA), are rightly focused on the rules under which biosimilars can be developed, manufactured, sold and used. As with the original drugs they seek to be similar to, biosimilars must be safe for patient use.

As the FDA moves toward issuing final guidance on biosimilars it is important that they consider the following commonsense safety rules that will continue to keep our medicines safe and effective:

  • Like the reference drugs they would copy, all biosimilar drugs should face extensive clinical trials to determine their safety and effectiveness.
  • If the original biologic treats multiple ailments, the follow-on biosimilar should be required to pass clinical trials on each and every one of those therapeutic applications. Nothing should be assumed with our lives at stake.
  • All biosimilars should have unique names to eliminate any and all confusion for patients, physicians, pharmacists, and regulators. This would also facilitate the extensive tracking system that must be in place to mitigate problems and track any adverse reactions after each biosimilar hits the market.
  • At the pharmacy, both patients and physicians should be fully informed before any drug switch involving biosimilars is made. That is simply commonsense policy to protect patients from what could be serious adverse reactions, and there should be no debate on this critical safeguard.

Patient safety must come first if we are to reap the benefits of these new lifesaving medicines.