Unconventional Infusions: Considerations for Biosimilars and Home Infusions

Christina Ha, MD, of Cedars-Sinai in Los Angeles, California, presented on how to navigate home infusions and switches of biologics and biosimilars on December 9 at the Advances in Inflammatory Bowel Disease (AIBD) 2021 meeting.

In the presentation, Dr Ha reviewed the biosimilars currently available in treatment of inflammatory bowel disease (IBD), as well as how to approach interchangeability. She also highlighted the factors that go into selecting patients for home infusions.

There are currently biosimilars available in the US for both adalimumab and infliximab.

FDA guidance when it comes to interchangeability of biosimilars state that the product must be biosimilar to the reference product, must be expected to produce the same clinical result as the reference product in any given patient based on indication, and, if being administered more than once to a patient, the risk in terms of safety or diminished efficacy of alternating or switching between the biosimilar and the reference product must not be greater than the risk of using the reference product without a switch.

Dr Ha reviewed several clinical trials, such as NOR-SWITCH and VOLTAIRE-CD, which aimed to evaluate the safety and efficacy of both using biosimilars instead of the reference products, as well as switching between the biosimilar and reference product. Some trials also investigated the effect of double or multiple switching: switching a patient from the reference to a biosimilar, and then switching from the first biosimilar to a second biosimilar. All trials found that use of the biosimilars and switching were safe and effective, and on par with use of the reference drugs when it came to all outcomes, including trough drug level, adverse events, and clinical remissions.

In 45 US states and Puerto Rico, laws have been passed that allow pharmacy-level substitution of interchangeable biosimilars, enabling a biosimilar to be substituted for the reference product at the pharmacy without a change from the prescriber.

When it comes to discussing biosimilars with patients, Dr Ha stated that clinicians should build confidence with early information and education, emphasize that biosimilars are not a new mechanism of action, and use the proper term “biosimilar,” rather than refer to the agents as generics. Clinicians should also point out that this is not a compromise on the quality of care for and that the biosimilar will be treated largely the same as the reference product would be.

Dr Ha also reviewed the option for infusions done in that patient’s home, rather than at a facility or hospital. She referenced a number of studies that generally showed a higher risk of adverse events, emergency department visits, or hospital admission after home infusions when compared to conventionally administered infusions. Home infusions also appear to increase the odds of nonadherence and discontinuation. However, home infusions could decrease the therapy-related logistical burden for carefully selected patients, such as those with more resources and fewer comorbidities. The benefits of home infusions for the patients are convenience (flexible hours, no transportation issues); patient comfort; safety (avoids potentially crowded spaces or hospital-acquired infections; and a nurse-to-patient ratio of 1:1.

Dr Ha laid out the factors to take into account when considering a patient for home infusion, such as stable dose and interval, the patient’s clinical response or remission, the condition of the patient’s veins, risk for infusion reactions, and risk factors for complications such as increased comorbidity. There are also protocol-related factors to consider with home infusion, she stated, involving evaluation of the home environment, infusion and infection protocols, ability to draw blood if necessary, and how all authorizations, renewals, medication ordering, deliveries, and administration are coordinated.

—Allison Casey

Ha C. Biologics/biosimilars, go home. Navigating home infusions and switches. Presented at Advances in Inflammatory Bowel Disease annual meeting. December 9-11. Orlando, Florida.