Biosimilars Month in Review: September 2023

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The biosimilar month in review highlights an exclusive HCPLive interview with leading experts discussing the importance of patient education, the latest data regarding switching between the reference drug and its biosimilar, and the efficacy of infliximab biosimilars among patients with inflammatory conditions. 

Clinicians Weigh in on Biosimilars, Patient Education

Biosimilars Month in Review: September 2023

Although the promise of equivalent therapeutics at a reduced cost to payers and healthcare systems was enticing, the real-world adoption of biosimilars has been less than optimal in the US and abroad, as demonstrated in the Spherix Global Insights third quarter update, in which rheumatologists, gastroenterologists, and dermatologists were surveyed on their preferences, comfortability, and knowledge of prescribing biosimilars.

Additionally, with an interest in learning more about real-world uptake and conversations between patients and providers regarding biosimilars, HCPLive sat down with a trio of experts and asked to what level patients need to be educated regarding biosimilars, bioequivalence, and interchangeability.

Survey Reveals Adalimumab-atto Maintains Leadership in US Adalimumab Biosimilars Market

Results of a Spherix Global Insights survey revealed adalimumab (Humira) is steadily losing its popularity as the biosimilar market continues to expand.

However, the embracement of biosimilars varied among different specialties, with dermatologists demonstrating the highest resistance to change, while rheumatologists and gastroenterologists had less hesitancy. Despite a broad understanding of current biosimilars, many specialists expressed they did not know how to differentiate between the recently available biosimilar options.

Experts' Perspectives: Optimal Levels for Patient Knowledge on Biosimilars

Below is a preview of the interview:

How informed should patients be regarding biosimilars and interchangeability?

Ryan Haumschild, PharmD: We try to keep it really succinct, right? These have been used before, these are data-backed, and the FDA has come forward with biosimilar infrastructure to approve these products. And I think that's the best way for patients to know. They may not need to really get in the weeds. They don't need to get too far into “We flip the pyramid and analytical studies of the base”. What they want to know is it safe, effective, equivalent, and it can be offered at a lower cost, potentially, to my healthcare system or to the payer group. So, that's why it's been preferred.

Bincy Abraham, MD, MS: It really depends on the patient. I have patients who want every single detail about everything that I'm prescribing, ordering and whatnot. For those patients, I need to give them the nitty-gritty of everything.

On the other hand, I have another group of patients, they are completely in the in the group where they feel "Okay, my physician is providing me with this medication and recommends this medication. I trust this physician, because I've known them for many years, and they have taken care of my disease for all these years.”

Then there's always the middle group, that bell curve, where some of them want some additional information, and some may not need as much. I try personalizing it to what they would need.

Jamie Thale Brogan, BA, MS, CEN: Anytime I have seen a patient who is on adalimumab or infliximab, or really starting with all biologics, just starting the conversation that biosimilars are here, we understand them, we are comfortable with the transition, we are happy for you to transition, and, if this comes up, just know that the most important thing about transitioning is staying on schedule, because that'll maintain how effective your treatment is, and avoiding the progression of disease that we've all been trying to do.

Switching Between Biologics, Biosimilars

Biosimilars, a cost-saving alternative to the bio-originator, are complex molecules designed to be highly similar regarding safety, efficacy, and quality to the biologic reference product. Tumor necrosis factor (TNF) biosimilars for patients receiving biologic disease-modifying antirheumatic drugs (bDMARDs) have been a staple for patients with rheumatoid arthritis (RA) when available.

Switching Between TNF Biologics, Biosimilars Deemed Safe in RA

Single switching between approved TNF biologics and biosimilars was demonstrated to be safe and effective in patients with RA, according to a study led by Bruna de Oliveira Ascef, PhD, PharmD, associated with the Department of Preventative Medicine, University of São Paulo, Brazil.

Based on an analysis of 17 randomized trials with a switching phase comprised of 6562 patients, findings supported the practice of switching reference biologics and biosimilar drugs of adalimumab, etanercept, and infliximab for this patient population.

No Increase in Disease Activity, Treatment Discontinuation with Switch to Biosimilar Etancercept

A comparative effectiveness analysis of patients in the British Society of Rheumatology Biologics Register in rheumatoid arthritis (BSRBR-RA) provided additional insight into the effects of switching from etanercept originator to biosimilar etanercept for nonmedical reasons.

“These data will be reassuring to clinicians and patients regarding any non-medical switch required of them,” investigators concluded. “More data are needed to investigate impact of non-medical switch not just with regards to arthritis disease activity, but also to patient well-being and quality of life, in terms of both short-term outcomes as well as over the long-term.”

Efficacy, Safety of Infliximab Biosimilars Across Conditions

TNF-α biologic agents are important agents in the treatment of non-infectious uveitis. Originator infliximab (Remicade) is a chimeric monoclonal antibody targeting TNF-α used to control intraocular inflammation and allow for quick tapering of systemic corticosteroids. The high cost of the originator drug, however, has led to the development of biosimilar agents, similar in molecular structure, pharmacokinetics, and clinical efficacy and safety to the originator.

Infliximab Biosimilar Maintains Inflammation Control in Non-Infectious Uveitis

Debra A Goldstein, MD, Uveitis Service, Feinberg School of Medicine, and colleagues, assessed inflammation control in patients with non-infectious uveitis treated with biosimilar infliximab-dyyb between April 2016 and January 2022.

In their conclusion, the team of investigators noted results showed promise for the treatment of non-infectious uveitis, not all biosimilar medications are equivalent to the originator or each other.

Infliximab Biosimilar CT-P13 Provides Consistent Safety, Efficacy Across 4 Diseases

Infliximab biosimilar CT-P13 was associated with no new safety signals at long-term use—as well as notable efficacy in the treatment of patients naïve to biologics or switching from originator infliximab or other biologics for a litany of rheumatic or gastric conditions for which the agent is used, according to new analyses.

New FDA Biosimilar Approval

FDA Approves First Tocilizumab Biosimilar for US Arthritis Patients

The FDA approved tocilizumab-bavi (TOFIDENCE), a biosimilar option referencing ACTMRA, for the treatment of moderately to severely active RA, polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (JIA).

The drug was approved on the basis of findings from a randomized, double-blind, single-dose, parallel phase 1 trial data comparing the pharmacokinetics, safety and immunogenicity to both US and EU reference tocilizumab across 3 patient arms.

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