Biosimilars Month in Review: April 2023


The biosimilars month in review highlights the positive safety and efficacy data of 3 biosimilars used to treat rheumatic diseases, gastroenterologists discuss the risks and benefits of prescribing biosimilars to their patients, and physicians emphasize the importance of patient education.

Gastroenterologists Weigh in on Prescribing Biosimilars

With more government interventions and emphasis on biosimilars, as well as an increasing amount of data reporting similar results in safety and efficacy, Ross Maltz, MD, associate professor and pediatric gastroenterologist in the Department of Pediatrics at the Ohio State Wexner Medical Center, noted that understanding the provider's practice habits and feelings regarding biosimilars is crucial. Previous studies have shown slow uptake of biosimilars and apprehension of standardization.

“There is still insufficient evidence and a lack of clear guidelines regarding the preference of one drug over the other and regarding the replacement of the original drug with a biosimilar during treatment,” wrote a team of Israeli investigators. “Many questions remain. Until enough evidence has accumulated from head-to-head comparisons, and until clear guidelines on the subject emerge, we decided to investigate the perception of Israeli gastroenterologists prescribing these drugs.”

Ross Maltz, MD: Understanding Biosimilar Acceptance in Pediatric Gastroenterologists

In an interview with HCPLive, Maltz discussed his recent study “Biosimilars for Pediatric Patients With Inflammatory Bowel Disease: Pediatric Gastroenterology Clinical Practice Survey.” The cross-sectional survey indicated that most pediatric gastroenterologists reported being comfortable prescribing an infliximab biosimilar and were accepting of a one-time switch to the biosimilar for patients in clinical remission.

However, the study highlighted the need for more education among healthcare providers and patients about biosimilars. He noted that another study surveyed pediatric patients and their parents about their understanding of biosimilars and found that most had no familiarity with them. Among parents who had heard of biosimilars, there was a negative association with them, likely due to misinformation or lack of information.

Most Israeli Gastroenterologists Prefer Brand-Name Drugs Over Biosimilars

Although most Israeli gastroenterologists do not have concerns about the safety and efficacy of biosimilars, most clinicians still preferred the brand-name drug option, particularly regarding adalimumab, according to a 20-question survey. Physicians were most opposed to switching to biosimilars in pregnant patients and those who have had difficulty achieving remission.

“With the rapidly gained momentum of biosimilars and the expected introduction of more biosimilars to the inflammatory bowel disease (IBD) field in the coming years, studies such as this one are very valuable,” investigators noted. “Its utility is in both directing the coming studies to answer unsolved questions and in guiding the delivery of special educational knowledge to IBD practicing physicians to relieve their concerns.”

Patient Perspective of Biosimilars

Study Details Perceptions of Biosimilars Among Patients with Immune-Mediated Diseases

A 16-question online survey completed by adults with rheumatoid arthritis, psoriasis, psoriatic arthritis, and/or IBD, data from the study underline the need for greater education on biosimilars, with less than 1-in-4 reporting having basic knowledge of biosimilars.

Upon analysis, results indicated 66% of respondents had not heard of a biosimilar, 24% had, and 10% were unsure. Further analysis indicted current biologic users were more likely than their counterparts to have heard of biosimilars (38% vs 12%). Among current biologic users, 43% reported being willing to accept a switch to a biosimilar, 32% were unsure, and 26% did not want to switch. Among those unwilling to switch, 51% reported concern about side effects, 42% reported concern about financial support, and 40% reported concern about efficacy.

“These findings indicate that patients would benefit from educational programs to help them understand biosimilars and the increased treatment options they provide,” investigators noted.

The Latest Biosimilars Data

Over the past month, several studies have demonstrated the safety and efficacy of biosimilars in treating rheumatic diseases, including rheumatoid arthritis (RA) and ankylosing spondylitis (AS). An infliximab biosimilar, CMAB008, reported similar therapeutic benefits when compared with the originator.

Etanercept, a tumor necrosis factor inhibitor (TNF), has been a main treatment option for patients with RA in the United Kingdom since its approval in the early 2000s. However, biologic therapies often come with high treatment and annual costs. Because of this, biosimilar options of the drug, first introduced in 2016, are now used to treat at least 90% of new patients.

AS, a chronic condition that is often difficult to treat effectively, is usually treated with nonsteroidal anti-inflammatory drugs (NSAIDs). However, biological disease-modifying antirheumatic drugs (bDMARDs) and TNF have been shown to be more effective and better suited for long-term use. Therefore, the development of more affordable biosimilar alternatives of these drugs is critical.

Etanercept Biosimilar Comparable to Originator in Biologic-Naïve Patients With RA

Real-world data from a large analysis proved that biologic-naïve patients with rheumatoid arthritis (RA) treated with either etanercept originator or biosimilar showed similar outcomes, including drug survival and disease activity at month 6 and 12.

“These data are reassuring to both patients and clinical teams when considering starting etanercept originator or biosimilar therapy as their first biologic,” wrote lead investigator Lianne Kearsley-Fleet, PhD, epidemiologist at the Centre for Epidemiology Versus Arthritis at the University of Manchester, and colleagues.

Adalimumab Biosimilar ZRC-3197 Improves Difficult-to-Treat Ankylosing Spondylitis

A prospective, interventional, uncontrolled, single-center trial enrolled 50 TNF-naïve adult patients (42 men and 8 women) with symptomatic active chronic AS currently receiving treatment between June 2016 and July 2018. Patients received 40 mg of ZRC-3197, an adalimumab biosimilar, subcutaneously every 2 weeks for 10 weeks.

Those treated with the drug showed significant early improvement in pain and function in patients with difficult-to-treat ankylosing spondylitis that lasted for up to 1 year. Patients who received the biosimilar reported early and significant improvements in areas of pain, NSAID requirement, and function. At 8 weeks, fewer than 15% of patients required daily NSAIDs and at week 12, 4 of the 9 patients taking daily NSAIDs had an Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) index response.

CMAB008 Demonstrates Equivalence to Infliximab for Rheumatoid Arthritis

In a recent phase 3 study, CMAB008 demonstrated non-inferior efficacy to innovator infliximab (Remicade), a monoclonal antibody used for the treatment of multiple autoimmune diseases, in patients with rheumatoid arthritis who were taking methotrexate. CMAB008 exhibited similar early and lasting therapeutic effects and was well-tolerated with comparable safety.

Investigators reported the primary outcome of American College of Rheumatology 20% improvement criteria (ACR20) response rate was reached by 110 (57.6%) of the 191 patients in the CMAB008 group, and 120 (62.2%) of the 193 patients in the infliximab group at week 30. When examining the ratios of subjects achieving ACR20 between the study groups, investigators stated that no significant differences were seen at weeks 2, 6, 14, or 22 in either the full analysis set or the per-protocol set. No significant differences of ACR20 and ACR50 were identified between the CMAB008 group and the infliximab group for any evaluation point throughout the study.

According to the study, these findings offer essential guidance in establishing the interchangeability of biosimilars with reference products.

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