Biologic drugs are often referred to as ”miracle drugs“ for good reason—they can often treat serious illnesses such as cancer, rheumatoid arthritis, and multiple sclerosis far more effectively than the traditional chemical drugs that preceded them.
And though the advancement of these products is undoubtedly of paramount importance to the medical community and millions of patients around the country, we must be aware of a potential danger that has arisen as a result of biologics’ advent: biosimilar drugs.
Biosimilars are meant to copy approved biologic drugs in the same way generic chemical-drugs replicate approved ones. But unlike chemical drugs, biologics are complex organisms and cannot be copied exactly. This is extremely important, as even the smallest variations in the structure of two drugs can lead to significant differences in their safety and efficacy.
Despite this, there currently exists only an outdated, abbreviated approval process for biosimilars in the United States, which was created more than two decades ago in 1984.
The good news is that the recently passed Patient Protection and Affordable Care Act directed the Food and Drug Administration (FDA) to create a new approval process, or “biosimilars pathway,” and the agency recently took action, holding a meeting in Maryland where various entities discussed their thoughts regarding the best way to create the new pathway. This was a good start, and we hope the FDA will continue with this open minded and patient approach to establishing their new approval system.
Had we been present at the meeting, the Alliance for Safe Biologic Medicines (ASBM) would have advocated for a pathway that protects patient safety while incentivizing the innovation of new, accessible medicines to further improve health outcomes in the United States. Also, we would have reminded the agency to keep in mind that medical decisions must be kept in between patients and their doctors, as no one knows the individual needs of a patient better than their own physician.
If the FDA’s keeps these basic points in mind while creating their biosimilars pathway, it will help ensure that this generation’s “miracle drugs” continue to improve health outcomes in America for years to come, and that no unnecessary harms are suffered by American patients at the hands of improperly tested biologic drugs