October 15, 2012 (Vol. 32, No. 18)

Standards for Interchangeability and Physician Notification of Substitutions Remain Key Issues

From the discovery of the polio vaccine to the first successful heart transplant, Americans have always had the benefits of cutting-edge medicine. Today, we stand on the threshold of yet another major advancement that could open the door to providing more cost-effective treatments to patients across the country.

Under the Affordable Care Act, Congress authorized the FDA to create a new pathway for the approval of copies of next-generation biologic drugs that are already approved and on the market.

Biologics are biopharmaceutical products that exhibit high molecular complexity and are derived through very sensitive manufacturing processes. They are much more complex than traditional, chemically derived pharmaceuticals. Biologics are given to patients to treat diseases such as cancer, psoriasis, Crohn’s disease, and rheumatoid arthritis.

These copies, called biosimilars, are near-reproductions of the original—or innovator—biologic drug, and if manufactured safely they can expand access to these life-saving, life-enhancing medicines.

While these advancements are much welcomed, to ensure patient safety, regulators must insist that any biosimilar product passes rigorous clinical testing before it is allowed on the market.

The process for discovering, manufacturing, and testing biologics is very challenging, and thus it is currently impossible to create an exact copy of a biologic innovator drug. A small difference in manufacturing process or in the cell line can alter the molecular structure between the innovator product and its biosimilar copies. Even slight variations could result in serious health implications for patients.

Once the FDA is convinced that a biosimilar is safe, it then has the authority to deem that product “interchangeable” with the original innovator medicine. However, the standard for interchangeability must be much higher than simply approval. The FDA must be able to assure patients and doctors that an interchangeable drug will behave exactly like the original drug when a patient uses it. And, considering the complexity of biologic medicines, it may be very difficult—if not impossible—to meet that standard.

And while substituting traditionally produced chemical generics for name brand drugs happens all the time (and without much consideration) because the products are identical, switching out biosimilars for the original biologic is a much different and potentially more dangerous prospect. Consequently, federal and state laws must be updated to ensure that policies don’t unwittingly lump biosimilars in with generic drugs on interchangeability.

Also, if the FDA does deem a biosimilar interchangeable, 85% of U.S. physicians say they want to be notified before a patient is switched to a different product than the one prescribed and 86% of physicians want there to be “Dispense as Written” rules for biologic medicines. These findings are from a recent survey conducted by the Alliance for Safe Biologic Medicines and reflect physicians’ overarching concern that inappropriate substitution will encumber patient safety. The safest course is to have no substitution without the prescribing physician’s consent as is the policy of the Louisiana State Medical Society.

It is no secret that biosimilars are essential to potentially unlocking access to life-saving medications for millions of Americans. Providing our patients with affordable care is a must for physicians, but we must ensure that we are providing our patients with the safest treatments available.

It is critical that the FDA put mandates into place that require an open communication channel between physicians, pharmacists, and patients. By requiring physician notification and the clear naming of biosimilar drugs, we can make sure our patients are given the most cost efficient and safest treatments possible.

Donald J. Palmisano, M.D., J.D.

Donald J. Palmisano, M.D., J.D. ([email protected]), is the former president of American Medical Association and is clinical professor of surgery and clinical professor of medical jurisprudence at the Tulane University School of Medicine.

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