AMCP: Are You Armed to Succeed with Biosimilars?

The introduction of biosimilars could mean significant reductions in health care costs; however, education and preparation are required to be properly armed for their successful use, said Steven Lucio, PharmD, BCPS, senior director of clini­cal solutions and pharmacy program development for Novation, during AMCP Nexus 2015.

Currently, filgrastim-sndz is the only biosimilar that has been approved for use in the US but, more approvals are likely on the horizon.

“The biosimilar approval process has been in place for 5 years, and yet we currently have only 1 biosimilar approved,” Dr Lucio said in an interview. “However, between now and 2020, we could see biosimilar com­petition for all of the top molecules that represent the largest part of our pharmaceutical costs.”

He noted that organizations need to prepare now for the introduction of biosimilars so they are able to use these drugs on day 1 and not miss out on the opportunity for cost savings associated with their use.

MANY LINGERING QUESTIONS

As the industry works to create guidelines for the use of biosimilars, there are still many lingering questions. For instance, Dr Lucio said the process for interchangeability remains undefined.

According to the FDA, an interchangeable biosimilar would be expected to produce the same clinical result in any given patient and can be substituted without the intervention of a health care provider. In addition, there is no greater risk of alternating between a bio­similar and originator if the biologic is administered >1 time compared with solely using the originator.

But the FDA has said it is still considering what information would be necessary to determine that a biological product is interchangeable with a refer­ence product.

A clinical trial of filgrastim-sndz by Blackwell et al (Ann Oncol. 2015;26:1948-1953), found that alter­nating between the biosimilar and reference product produced no clini­cally significant differences in terms of safety and efficacy.

However, Dr Lucio said that gain­ing the designation as an interchange­able is difficult on initial approval and each state will have its own approach. “Also, the hurdle for interchangeability could be more challenging for some molecules, particularly those that are used to treat a serious illness and those that are administered for long periods of time.”

Another factor to consider is how biologics can be used in indication extrapolation. According to information from the FDA presented during the session (https://1.usa.gov/1Y6KHmi), extrapolation can be considered when:

• Mechanism of action is understood
• There is target binding in both indications
• Differences in toxicity or immunogenicity can be evaluated and determined
• Pharmacokinetics for each indication is known.

“The extent to which a scientifically sound justification can be made to support extrapolation will vary by molecule and the populations treated with the molecule,” noted Dr Lucio.

KEY ROLE OF PHARMACISTS

Due to the complexity of biosimilar adoption, Dr Lucio said substantial education will be necessary for physicians,

pharmacists, nurses, patients, and others in the industry. Education will be required to enable the comparison of a drug’s safety, efficacy, convenience, and cost. Along with education to allow clinical trial analysis and critique, there also needs to be medication safety assessments and financial analyses.

Dr Lucio also discussed the need for pharmacists to assume a key leadership role in advocacy efforts. Pharmacists

must prepare themselves to be able to provide objective and valid information on this new class of agents to patients and health care organizations. “Pharmacists truly are the most strategic stakeholders in advancing the biosimilar paradigm,” he explained. “No other discipline has the training to understand the concepts related to biosimilar development, review, and approval to help physicians

develop a level of trust with these products.”—Jill Sederstrom