FDA approves Zarxio as the first U.S. biosimilar

By Chris Hanson-Ehlinger
Wed, Mar, 11, 2015 @ 16:03 PM

describe the imageThe Food and Drug Administration approved Zarxio as a biosimilar for Amgen’s reference product, Neupogen, in March. Zarxio, a Novartis product, has the same indications as Neupogen, primarily for managing blood disorders caused by cancer treatments. Zarxio is now approved as a safe and effective treatment, representing a viable alternative to Neupogen.

Plan sponsors won’t reap immediate benefits

Insiders predict a month’s supply of Zarxio could fetch 30 percent less than the original Neupogen. With Zarxio, science and technology developed a lower cost alternative but it will likely be courtrooms and lawyers that determine Zarxio’s market success. Due to pending litigation the launch date for Zarxio has not been finalized. Amgen, the maker of Neupogen, filed a petition in February to prevent Zarxio’s launch. A district court hearing on the case is scheduled for March 13, although some sources report an April launch date regardless of the March decision.

Semantics matter

In addition to litigation among the drug makers, state laws also impact the use of biosimilars.The FDA can approve a drug as a biosimilar or an interchangeable biosimilar. Laws in eight states dictate that a biosimilar cannot be substituted by a pharmacist unless the drug is deemed an interchangeable biosimilar (North Dakota, Florida, Oregon, Virginia, Utah, Delaware, Massachusetts and Indiana). Based on its current status as a biosimilar, pharmacists in these states will not be able to substitute Zarxio (filgrastim-sndz) for Neupogen (filgrastim). State laws also address prescriber permission or objection, provider notification, patient notification and counseling, record keeping and labeling criteria. The FDA naming convention for biosimilars is also under debate, adding another layer of complexity to the category.

Prepare your plan

Although biosimilars are touted as a solution to high cost specialty medications, plan sponsors will have to wait. In the meantime, prepare your plan to handle products that don’t offer clear substitution references, such as Zarxio and other biosimilars nearing FDA approval. For example, consider including a cost share level using the broader term ‘select alternatives’ when making summary plan design changes as opposed to specific words such as ‘generics’ or ‘biosimilars’. Also, think about waiving the cost-share for members who accept select alternative products. The few dollars the plan spends in covering the member cost share for alternatives could save the plan thousands of dollars.

While Zarxio’s groundbreaking status is exciting, it offers no quick fix. It does, however, set the stage for additional products—and additional conversations—about how biologics fit within today’s medical and pharmaceutical benefits.


Phil DeNucci, RPh, is a managing consultant working with Burchfield’s key self-funded employer and coalition accounts to help them manage their pharmacy benefit programs. For more information please call 800-778-1359 or send us a note (http://www.burchfieldgroup.com/contact/).

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