FDA advisory panel votes against approval of DMD drugThe case for a wider use of biosimilars in lieu of more expensive biotech drugs just got stronger thanks to a study conducted by researchers at Johns Hopkins Bloomberg School of Public Health and published earlier this month in the Annals of Internal Medicine. The study concludes that biosimilars have indeed earned their “similar” designation when it comes to comparing them to the name-brands they are designed to compete with—in all but cost.

Biologic medications are derived from antibodies and proteins produced by living organisms and therefore are more challenging to produce than drugs wholly comprised of chemicals. Furthermore, unlike generic drugs which are exact replicas of their brand-name counterparts (and therefore considered “bioequivalent”), biosimilars can’t be true copies of the original upon which they’re based.

But according to the U.S. Food and Drug Administration (FDA), the differences are not of a type that will impact the patient: “Biosimilars are highly similar to the reference product they were compared to, but have allowable differences because they are made from living organisms. Biosimilars also have no clinically meaningful differences in terms of safety, purity, and potency from the reference product.”

Despite the FDA’s assurance of adequate similarity, though, drug-makers have been wary of biosimilars precisely because they can’t be identical to the medicines they replace. Therefore, this study has the power to go a long way toward normalizing the use of biosimilars in healthcare. Still, some pharmaceutical manufactures oppose approval of biosimilars and contend that they should not replace a brand-name medication in the absence of a patient’s consent.

Biosimilars offer the potential for immense savings

Although the Affordable Care Act includes a provision that urges the development of biosimilars, only two have been approved by the FDA in the last six years. That’s likely to change, however. According to IMS Health Informatics, there are 50 biosimilars under development, and they have the potential to save health systems in the U.S. and Europe a whopping $110 billion over the course of five years.

The Johns Hopkins analysis was based on 19 studies exploring the efficacy of biosimilar meds used to treat psoriasis, rheumatoid arthritis, and inflammatory bowel disease. The finding? That the biosimilars are indeed comparable to the biotech originals—in performance, but not in price.

Will the study boost the number of biosimilars in the U.S.?  

Caleb Alexander, the lead researcher of the study, says, “Hopefully, this will encourage the brisk adoption of these products. There is no question that greater competition in this market will benefit patients, prescribers and society in the long run.”

The first biosimilar FDA-approved in the U.S. is Zarxio, an immune-boosting medication intended for use by chemotherapy patients. It’s estimated that Zarxio will offer a savings of $6 billion per year over Amgen’s Neupogen, its biologic reference product.

Last April, a second biosimilar was approved by the FDA, this one designed to treat Crohn’s disease and colitis; Inflectra is the biosimilar counterpart to the name-brand Remicade produced by Johnson & Johnson. Europe, Canada, and Asia currently have biosimilar meds available that are in the same class as Inflectra and Remicade.


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