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Biosimilars and Transparency

August 06, 2015

Biosimilars offer new treatment options for patients at a fraction of the cost of their reference medications, but concerns persist about distinguishing the new products from their originators and ensuring transparency when they’re substituted for established therapy.

In August 2014, national organizations representing physicians who frequently prescribe biologics sent a letter to the U.S. Food and Drug Administration (FDA) to express concern about the naming of biosimilars. The groups stated that standalone names would alert providers that biosimilar products are comparable, but not identical, to the original, and that clear labeling might actually give physicians more confidence in using the products and promote more widespread use. They also cited a recent survey of European physicians who believed biosimilars and reference drugs that share International Nonproprietary Names (INNs) are approved to treat the same conditions, even though that’s a false and dangerous assumption that could result in patient harm.

Last May, a coalition of physician and patient organizations wrote the FDA to express concern that the label on the packaging of Zarxio (filgrastim-sndz), the first biosimilar approved in the U.S., contains the same clinical data information as its reference medication and does not include information about its biosimilarity or interchangeability ( That oversight might lead physicians to assume that, like generics, biosimilars have the same effect on patients and are interchangeable with the reference drugs.

The letter’s authors agreed with the FDA’s 2012 Draft Guidance concerning biosimilars that called for labels to state which products have been approved as biosimilars and whether they have been deemed interchangeable with the reference product. “We are concerned the label of Zarxio does not make either statement,” the organizations wrote.

The naming issue is a matter of patient safety, because if a patient experiences an adverse event, drug safety authorities need to quickly track and trace which product and manufacturer were responsible in order to limit the number of cases, said Steve Marmaras, manager of state and national advocacy for the Global Healthy Living Foundation, a patient advocate group based in Upper Nyack, New York.

His organization is focused on ensuring physicians and patients are notified when biosimilars are substituted for biologics. “Patients in our arthritis community or those with other chronic autoimmune diseases need to be concerned about how biosimilars are substituted and named, because understanding exactly what you have been prescribed versus what you actually receive is vital to track a patient’s responsiveness to treatment and possible adverse events.”

Mr. Marmaras said that once biosimilars are approved, pharmacy boards in individual states will be responsible for how and when biosimilars can be substituted, and how much responsibility pharmacists have in notifying physicians and patients of the switch. According to Mr. Marmaras, 17 states have incorporated the substitution of biosimilars into pharmacy practice laws and all state that biosimilars are interchangeable only when the highest class of similarity with references products is achieved.

Pharmacists have an important role to play in helping patients and physicians communicate with each other about how biosimilars are used, said Mr. Marmaras. “Pharmacists will need to understand which are available as a substitute for an originator biologic and which are not,” he commented. “It will also be vital that they are able to explain what ‘interchangeable’ means to patients so that they, in turn, can communicate to their physician about the opportunity to switch medications. After all, a substitution might benefit a patient, if it means identical treatment results with a reduced cost.”


—Dan Cook

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