Update on FDA Biosimilar Guidance

The biosimilar market is starting to heat up. Merck & Co. and Samsung Bioepis recently launched Renflexis (infliximab-abda), which is a biosimilar to Johnson & Johnson’s Remicade (infliximab). The companies announced some fairly aggressive pricing, too: a 35% discount to the list price of Remicade. The new biosimilar will join Pfizer’s Remicade biosimilar product called Inflectra (infliximab-dyyb) and Sandoz's Zarxio (filgrastim-sndz) on the market in the coming months.

James Stevenson, PharmD, FASHP, a professor at the University of Michigan College of Pharmacy, said several more products are in the pipeline or up for consideration by the U.S. Food and Drug Administration (FDA), and he wouldn’t be surprised to see 3 or 4 more products approved within the next 6 to 12 months.

Dr. Stevenson recently provided an update on the FDA’s biosimilar guidance and talked about why pharmacists will shoulder much of the responsibility in ensuring providers understand and accept the new therapies in order to provide patients with improved access to needed therapies.

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What’s the latest on the naming and interchangeability requirements for biosimilars?

The FDA has issued its final naming guidance, but no one seems to be pleased with the format, which calls for the use of a core name plus a 4-character suffix that’s devoid of meaning. Many people—myself included—are concerned that using nonsensical suffixes will make it difficult for providers to determine which products patients are taking. That naming guidance is supposed to aid pharmacovigilance, but the current system could do more harm than good.

The FDA also released its proposed guidance on interchangeable biosimilars earlier this year. I don’t think the guidance is extremely helpful, because it says the FDA will work with biosimilar manufacturers on a case-by-case basis to decide what types of studies are needed to determine interchangeability. Biosimilar manufacturers are going to engage in discussions with the FDA to design the studies that are required to achieve that designation.

What's your sense of what prescribers know and don't know about biosimilars?

There’s still a fairly large knowledge gap among physicians, but it’s improving over time as more products enter the market and educational efforts have increased. Most physician specialty associations and organizations initially pushed back against biosimilars. Their members did not want to be forced to use the new medications and voiced concern about the complexity and safety of the agents.

Recently, however, a number of physician organizations have changed their positions on biosimilars. They still have general concerns about switching patients to biologics, but they also acknowledge that the actual evidence and real-world usage of the drugs—particularly in Europ —have been extremely positive. Physicians are beginning to realize that biosimilars are fairly safe based on the regulatory guidelines that are currently in place.

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What can pharmacists do to promote biosimilars?

Pharmacists play an important role in educating prescribers, nurses, and patients about the safety and efficacy of the products. Everyone will have questions, and the more prepared pharmacists are in being able to answer those questions, the better off we’ll all be.

Patients will wonder about what differentiates biosimilars from generics and will ask if it’s acceptable for them to consider biosimilars. Pharmacists need to be able to address those types of concerns. They must also able to clearly explain what makes biosimilars different from other medications and detail how the FDA’s approval process ensures the products are safe and effective.

What barriers have to be overcome before biosimilars have a significant impact on patient care?

The FDA’s abbreviated approval pathway relies heavily on physical and chemical analyses, and less on clinical trials. That’s a potential issue, because clinicians have been trained to rely on clinical trials when assessing the safety and effectiveness of medications and therefore must become more informed about the entire approval process. They must feel comfortable that the regulatory standards in place are rigorous enough to ensure the safety and efficacy of biosimilar products when they reach the patient population.

Biosimilars have a very good track record after 10-plus years of a similar abbreviated approval process in Europe—there are approximately 25 products on the European market and not a single one has been removed because of adverse outcomes. We don’t have as much direct experience with biosimilars in the US, but there haven’t yet been significant safety concerns with the currently approved products.

What should formulary committees consider when assessing biosimilars?

There are several important factors. One is dosage forms, which may be different for biosimilars and their reference products. For example, Zarxio (filgrastim-sndz; Sandoz) comes packaged only in prefilled syringes, but the originator product is available in both prefilled syringes and vials. The prefilled syringes are suitable for adults on a standard dose, but won’t work for pediatric patients who require weight-based dosing. That’s why formulary committees must ensure providers have access to dosage forms that are appropriate for specific patient populations.

There are also questions about whether or not the money patients spend on self-administered biosimilars will apply to the coverage gap in the Medicare Part D program, so biosimilars could actually increase out-of-pocket expenses for those on the therapies. That’s a nuance in the reimbursement guidelines that needs to be addressed.

—Dan Cook