On March 6, 2015 the FDA announced the approval of the US’s first biosimilar – Novartis’ Zarxio, a copy of Amgen’s drug, Neupogen (a white blood cell booster) for sale and distribution. The hope for biosimilar products as whole, is that they will lead to a more competitive marketplace with more drug options and lower prices. This hope has resulted in biosimilars being forecasted as one of the fastest growing segments of the prescription drug market. However, there is a very real question that drug safety advocates will be asking: Will the push for lower costs win out against public welfare?

A biosimilar is a biological product that is FDA approved by demonstrating both safety and efficacy that is highly similar to a previously approved biological product. Biologics are medicines that come from living organisms, are more complex to manufacture than traditional drugs, and cannot be exactly copied like a chemical compound. At the time of approval, a biosimilar should have no clinically meaningful differences in terms of safety, purity, and potency than its branded counterpart. When considering approval of a new biosimilar, FDA relies heavily upon safety and efficacy data from the previously approved branded biological product.

Unlike generic small molecule compounds, biosimilars will bear a distinct label from their branded counterparts. As such, FDA will monitor post approval safety of biosimilars by relying on the FDA Adverse Event Reporting System (FAERS), the same as it does for branded drugs. As biosimiliars start to flood into the market, with their effect on the mass population largely unknown, the concern regarding post approval surveillance is increasing out of fear that FDA will be unable to properly monitor this glut of new drugs. Past experience shows that the FDA is often delayed in their reactions, if there is a reaction at all.


Related Read: An Indecent (Drug Safety) Proposal


It’s this combination of issues – lack of FDA funding, a flood to market of new drugs, and misplaced resources that demand that managed care organizations, hospitals and health systems take post-marketing drug safety into their own hands. The risk of patient harm and the downstream medical costs associated with that harm is too great. By using real-world, independent big data and statistical analytics, early warnings of potential issues are possible and actionable without waiting for FDA.


Related Read: RxOutcome – A New Paradigm in Drug Safety


In order to ensure this practical approach is feasible, they need to be able to have access to the same information that the FDA is collecting and a strong analytical platform to make sense of that information.

For example, FAERS data, filtered, standardized, and analyzed by AdverseEvents shows that Neupogen, Zarxio’s branded equivalent has 14 serious AEs that are not on Neupogen’s label, but are being reported at elevated rates, and thus have triggered an AdverseEvents Explorer Active RxSignal. Many of these events are on the FDA’s Designated Medical Event (DME) list, a group of roughly 80 AEs that the FDA pays special attention to and are more often than not, drug induced.

As Zarxio is put on formulary, prescribed by doctors, and then taken by patients how will its safety profile diverge from Neupogen? Only time will tell, but managed care, hospitals, and health systems need to stay on top of this data and not wait for FDA action.

It’s the only practical approach.

To download AdverseEvents’ initial safety review of Zarxio, click here.


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Jim Davis

Jim Davis

Executive Vice President

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Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.