[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patients
FDA recently reached a milestone by approving the first biosimilar in the United States. Biosimilars have the potential to increase access to vital biologic medications for many patients living with chronic and life-threatening conditions.
Made from living organisms, biologic medicines are far more complex and much more difficult to develop and manufacture than traditional chemical drugs. These biosimilars are medicines that are highly similar but not identical to biologic medicines. Because of the uniqueness and complexity of biologics, biosimilars are not generic copies of biologic medicines.
When Congress passed the Affordable Care Act (ACA), it gave FDA regulatory authority to review and approve biosimilars. Although FDA recently approved the first biosimilar and is currently considering approval of several more, the agency has yet to issue guidance on a range of issues critical to patient safety, including interchangeability, whether biosimilars will have distinct names, what information will be on biosimilar labels, and whether biosimilars will be tested for each condition for which they are indicated, as is required of their reference biologics.
FDA is establishing precedent now that will guide future approval of biosimilars, and it is critical that the agency get the process right the first time. FDA guidance–and the opportunity for public review and comment–on the standards for biosimilar approval will ultimately drive public confidence for this new category of drugs.
There are tremendous variations in the complexity of biologics, and the difference in therapeutic response to biologics from patient to patient is substantial. Even a minor difference between a biosimilar drug and the original biologic product could have a significant adverse health impact for a patient. Consequently, a one-size-fits-all approach to the approval of biosimilars could threaten patient safety.
Concerns are particularly high given the results of a study done in Ireland on a biosimilar that is approved in Europe and whose application is pending with FDA.1 The study found that of the patients with inflammatory bowel disease who received the biosimilar, 80% of patients had to be readmitted to the hospital with serious adverse reactions, whereas only 5% of patients who used the innovator biologic had such reactions.
This instance clearly should move FDA to require that manufacturers of both innovator biologics and biosimilars conduct rigorous testing to prove that their product works safely and effectively in each and every condition and distinct patient population for which it has applied for use.
Physicians and patients must have all the information necessary to make a fully informed choice about whether to use an innovative biologic or biosimilar. All products, including biosimilars, should carry distinguishable, nonproprietary names, as well as brand and lot information to quickly trace a product to an adverse event.
Patients, especially those with rare and chronic diseases, are eager for new and affordable treatments. Patient safety, however, should not be sacrificed in the name of regulatory expedience. We urge FDA to issue guidance on the outstanding issues critical to patient safety.
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Murphy C, Sugrue K, Mohamad G, et al. P505 biosimilar but not the same. Poster presentation. Inflammatory bowel diseases. European Crohn’s and Colitis Organization, 2015.