This guest commentary is written by Robert Goria, Chief Trade Strategy Officer, CarePartners Pharmacy. The article addresses a practical approach to navigating biosimilar substitution, as we may soon be seeing significant change in the meaning of interchangeability for biosimilars.
The US biologics market is undergoing a quiet but consequential shift. Years after the Biologics Price Competition and Innovation Act created a pathway for biosimilars, regulators and payers are now expanding how these products are distributed, particularly through pharmacy-level substitutions. Although improving access and lowering costs are worthy goals, policies that enable biosimilar substitution without physician involvement raise important concerns about continuity of care, transparency, and patient trust.
Today, federal and state frameworks require a biosimilar to receive an FDA “interchangeable” designation before a pharmacist may substitute it without prescriber consent. However, recent signals from the Centers for Medicare & Medicaid Services suggest a broader practice may emerge, allowing Part D plans to substitute even non-interchangeable biosimilars mid-year for formulary management. In many instances, this practice already occurs when payer policies or PBM’s force a switch among biosimilars or between reference drugs and biosimilars.
Multiple formulary-based changes, especially when tied to payer contracting cycles rather than clinical decision making, risk disrupting care regimens, confusing patients and physicians and serve to erode trust between patients and their providers. Patients trust that clinical decisions will be made by a trusted physician, not by non-transparent formulary updates.
Supporters of pharmacy-driven biosimilar substitution point to faster adoption and cost savings, noting that pharmacy conversions outpace physician prescribed biosimilars. However, biologics are not small-molecule generics. They are complex therapies with immunogenic and clinical nuances. Although FDA-approved biosimilars are deemed safe and effective, many clinicians remain concerned about repeated switching, therapeutic continuity, and patient perception, particularly the potential for “nocebo” effects. Nocebo effect can be defined as “a negative response or harmful effect that occurs because a person expects an adverse outcome, even when the treatment or substance they receive is inactive. It is the opposite of the placebo effect, instead of improving symptoms through expectation, symptoms worsen because of negative expectations.”
Paramount to the topic of interchangeability is the issue of the physician–patient relationship. Patients expect treatment decisions to be made by clinicians who know their history, not by silent formulary changes. Substitution without prescriber awareness can create confusion and erode trust.
There is a practical middle ground. First, real-time prescriber notification should be a baseline requirement. When a biosimilar substitution occurs, interchangeable or otherwise, an automated alert through electronic prescribing systems should notify the clinician immediately. This ensures accurate medication records and appropriate follow-up.
Second, patient education at the point of dispensing must be strengthened. Patients deserve clear, plain-language explanations about what is being substituted, why it is safe, and how it supports their care. Although many states require some form of notification, standards vary widely. A federal baseline would ensure consistent patient protection.
Specialty pharmacies can play a critical role here. Given their close engagement with patients using complex therapies, specialty pharmacists are uniquely positioned to educate patients, coordinate with clinicians, and reinforce that biosimilar switches are clinically sound, not arbitrary cost decisions.
Biosimilars hold real promise, but their success depends on trust built through communication. As substitution policies evolve, transparency, notification, and patient-centered education must be built into the system. Cost savings should never come at the expense of clinical continuity or patient confidence, which are the foundation of good medicine.
This article was written by Robert Goria, Chief Trade Strategy Officer at CarePartners Pharmacy, a national specialty infusion pharmacy focused on niche therapies and markets.
