Switching to Biosimilars: Current Perspectives in Immune-Mediated Inflammatory Diseases

There exists a myriad of benefits which support switching patients with immune-mediated inflammatory disease (IMIDs) from reference biologics to biosimilars, according to authors who published a review in Expert Opinion of Biological Therapy.

Over the past 20 years, biological therapies have shifted the paradigm with respect to treating IMIDs. However, biologics incur high costs, partially due to the extensive level of research, development, and manufacturing that they require before tendering. As many biologics near or reach their patent expiration, the market has seen an influx of biosimilars, which can not only abate much of the financial burden reference biologics place on state-health budgets, but also exhibit comparable efficacy, immunogenicity, and safety profiles to its referenced “originator.”

In this review, the authors outlined potential reservations that are commonly associated with switching from a referenced product to a biosimilar while providing robust evidence that corroborates that the benefits of switching outweigh any detriments, while allaying any present concerns of patients and physicians by underscoring methods that are currently in place to ensure biosimilars render safe and effective treatment for all patients.

To evaluate the impact of switching from a reference product to a biosimilar, the authors assessed randomized controlled trials (RCTs), which are frequently conducted as part of the development and approval process of a biosimilar, to gauge any variances in performance. The data they ascertained were encouraging and suggest that potential safety, specifically as it relates to immunogenicity-related safety concerns, remains unchanged subsequent to a biosimilar switch from a reference.

Particularly, the authors identified three studies which have been published to date that explored multiple switching in IMIDs. Two studies were multicenter, randomized, double-blind, phase III studies in plaque psoriasis, which analyzed two references (etanercept and adalimumab) juxtaposed with their respective biosimilars (GP2015 and GP2017). Following three, six-week switches between the reference product and its corresponding biologic, the results indicated nominal effects with respect to treatment efficacy. Moreover, the third study, which was an open-label extension (OLE) of a multicenter, randomized, double-blind, phase III study in rheumatoid arthritis, suggested that switching from reference product (adalimumab) to biosimilar (FKB327) resulted in comparable efficacy, safety, and immunogenicity.

The authors noted that both physician, and patients alike (along with payers, and medical societies) have apprehensions when it comes to the adoption of biosimilars and cautioned that a biosimilar’s effectiveness can be compromised in an overly reluctant patient, creating what is known as the “nocebo” effect. However, the review proposes that as more data, real-world evidence, studies, and educational resources become available, it stands to quell most of the current concerns pertaining to biosimilar switching. Furthermore, for switching to biosimilars to become a success, a joint decision-making process between patients and physicians is imperative.

In their conclusion, the authors wrote that addressing “residual patient and physician concerns through education and ongoing real-world experience with biosimilars will play an important role in ensuring the acceptance and success of switching to a biosimilar, and ultimately to realizing the full benefits of biosimilars to society.”