Biosimilar Approval Brings New Awareness Levels for Community Pharmacists

The FDA’s March 6, 2015, Zarxio approval brought biosimilars into the spotlight once again, although Zarxio and other biosimilars continue to face hurdles. Community pharmacists should remain aware of the therapies in order to better assist their patients.

“Even though this may not be the biggest component of the day for a community pharmacist, they’re still going to get questions about it,” said Steven Lucio, PharmD, BCPS, senior director of Clinical Solutions and Pharmacy Program Development at Novation, in an interview with Pharmacy Times. “Being the local drug information experts, pharmacists are going to have to field these requests, and have to be prepared, even though they may not be dispensing the majority of these agents.” That may be the case with Zarxio, which tends to be administered in inpatient settings, outpatient clinics, and physician offices, or is provided by a specialty pharmacy, he added.

“As all health care providers begin to be reimbursed more on outcomes, all pharmacists, including retail practitioners, will need to ensure that patients are taking their medications as prescribed and that there is no confusion between biosimilars and branded medications,” he said. “Even if a patient is not getting their Zarxio from a retail pharmacy, they may be getting their other drugs in this setting. Therefore, retail pharmacies need to be able to field patients’ questions about this product and others.”

Biosimilars vs Branded Drugs

Biosimilars’ impact on community pharmacy will likely increase as the FDA approves more agents, as well as when the therapies receive the interchangeability designation that creates the path for biosimilar substitution. Still, it might be some time before Zarxio reaches patients, due, in part, to fluctuations in the biosimilar pathway and the biosimilar market. Currently, the product is undergoing patent litigation, which can involve the originator manufacturer analyzing the biosimilar data for patent infringements, Dr. Lucio said.

“Pharmacists have a huge role in ensuring the safe and effective adoption of biosimilars,” Dr. Lucio said. “Pharmacists will be the primary source of validated information for physicians and patients. This audience will have a lot of questions that will have to be answered correctly and effectively.”

The FDA has not yet released its final stance on biosimilar naming conventions, nor has it established criteria for biosimilar interchangeability. Although intended to occupy the same therapeutic place as traditional generic drugs, biosimilar products are not generics, Dr. Lucio added. The increased size and complexity of branded medications makes creating an identical replica impossible. This should not be cause for concern, however: branded biologic drugs vary from batch to batch and from lot to lot, which is expected for these types of products, he added.

Biosimilar products should work just like branded drugs, even though they are not exact duplicates of the branded biologics: the products have the same safety and efficacy as branded products but no clinically meaningful differences from the original product.

“Pharmacists should be comfortable filling prescriptions and dispensing biosimilars once they come to market,” Dr. Lucio said. “Various biosimilar drugs have been approved and marketed in Europe since 2006. Those products have worked as expected with similar safety and efficacy profiles … compared [with] the branded drugs.”

Barriers to Widespread Use

Many of the top-selling medications are biologic drugs, making biosimilars the most direct cost savings opportunity in the health care system over the next 4 to 5 years. “We need biosimilars,” Dr. Lucio said. “Given all of the concern with health care costs, the competition brought by biosimilars, and the resulting price reductions, biosimilars are absolutely necessary in order to maintain some control over pharmaceutical expenditures.”

Despite this, Zarxio and other biosimilars face several hurdles. In addition to patent litigation, physicians must specifically prescribe a biosimilar, expert organizations must accept the product and incorporate it into clinical practice guidelines, and patients need to accept the drug as a therapy option. Biosimilars will also need to realize the lower costs promised, which is partly governed by their placement on payor and pharmacy benefit managers’ (PBMs) formularies, Dr. Lucio said.

Ultimately, biosimilars’ fate rests on the as-yet undetermined interchangeability designation, as well as how each state handles biosimilar substitution. The designation provides the pull needed to reduce prices and to encourage patients to use nonbranded products.

“Insurance companies are likely to look at cost difference versus safety and effectiveness differences,” said Stephen Schondelmeyer, PharmD, PhD, professor of pharmaceutical economics at the University of Minnesota College of Pharmacy, in an interview with Pharmacy Times. “Most plans, if they cover the originator already, will cover the biosimilar product, but it’s not interchangeable. It takes away the economic leverage of payers to steer patients toward the biosimilar product.”

In addition, most states do not have substitution laws in place for biosimilar products, and those that do include language to make substitution difficult, Dr. Schondelmeyer said. “I don’t think Zarxio brings much change at this point, because you can’t substitute it,” he said. “It’s like a second branded drug coming into the market. The PBMs might favor one drug over the other, but the pharmacist dispensing doesn’t have much that they can do.”

Navigating the FDA’s Guidelines

Once the FDA establishes its biosimilar interchangeability criteria, each state will need to establish substitution permissions within their specific state, Dr. Schondelmeyer said. “Interchangeability does not give state-level substitution permissions in every state. “We should use very similar, parallel processes to those used for generic drugs at the state level, rather than most of the provisions that have added substantial administrative burden. It’s like requiring a pharmacist to get a doctor to represcribe the generic. It hasn’t really protected the patient, but has instead added substantial barriers to competition.”

Those barriers include requiring pharmacists to notify prescribers about the substitution and supply retail cost information for the biosimilar and the branded product, to notify patients about substitutions, and to maintain substitution records for specific time periods after dispensing a biosimilar drug. Furthermore, certain states require their boards of pharmacy to maintain a list of biosimilars and their reference products or links to the FDA’s product list.

According to a Pharmaceutical Care Management Association workshop on biosimilar substitution laws, North Dakota is the only state to enact biosimilar substitution legislation with patient and prescriber notification, pharmacy and prescriber recordkeeping, and biosimilar list requirements. Legislation in other states also contains portions of these provisions, but includes additional sunset clauses on some of the requirements.

The question for pharmacists is simple, Dr. Schondelmeyer said: “How do we make sure the process for substituting a biosimilar is not so burdensome that it discourages substitution? Pharmacists should be actively working with their state boards to encourage biosimilar substitution when appropriate.”