Jamie T. Brogan, MSN, APRN, FNP-BC

Experts talk about the impact of the launch of adalimumab biosimilar on their clinical practices and pharmacy.

Impact of the Launch of Adalimumab Biosimilars in Different Clinical and Pharmacy Settings

This is a video synopsis/summary of a panel discussion involving Jamie T. Brogan, MSN, APRN, FNP-BC; Kostas Botsoglou, MD; Jordan Axelrad, MD, MPH; Sophia Humphreys, PharmD, MHA; and Peter Lio, MD.

The discussion examines the impact of biosimilar launches in both pharmacy and clinical settings. Initially, the adoption of biosimilars was high in oncology, but more conservative attitudes were observed among gastroenterologists and rheumatologists. However, as more data became available, steady uptake occurred, particularly in rheumatoid arthritis (RA), leading to increased comfort among physicians.

In the pharmacy setting, surveys indicate rising comfort levels with biosimilars among healthcare providers, despite initial challenges in determining coverage by insurance payers. The broader availability of biosimilars is expected to potentially lower costs, although the complexity of navigating different biosimilar options remains a challenge.

In the clinical realm, the learning curve for both patients and providers persists, with a focus on understanding coverage policies to avoid delays in treatment access. Education efforts are crucial to ensure patients receive the appropriate medication. In rheumatology, uptake was initially slow due to the availability of unformulated original products, but increased gradually with payer enforcement of switches to biosimilars.

In dermatology, however, the uptake of biologics and biosimilars lags behind other specialties, presenting an opportunity for expansion of treatment options. Overall, improving comfort levels among healthcare providers and early utilization of biosimilars hold promise for enhancing patient care, particularly in stopping disease progression in conditions like inflammatory bowel diseases.

Video synopsis is AI-generated and reviewed by AJMC editorial staff.

Videos

discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

The Safety and Efficacy of Adalimumab Biosimilars in Inflammatory Diseases

The discussion shifts to the safety and efficacy of biosimilars across various inflammatory diseases. The VOLTAIRE-RA trial, featuring an approved interchangeable biosimilar, demonstrates safety, tolerability, and efficacy within predefined primary endpoints, extending to conditions like psoriatic arthritis, ankylosing spondylitis, and uveitis. Biosimilars have also gained approval for psoriasis and hidradenitis suppurativa, indicating their versatility across disease states.

The conversation highlights the reassuring performance of biosimilars across different populations and conditions, underscoring their equivalence to originator drugs. Data from randomized trials show comparable patient outcomes and safety between originator and biosimilar therapies, providing clinical reassurance.

Extrapolating findings from one disease area to another, like from rheumatoid arthritis to inflammatory bowel diseases or psoriasis, enhances clinical accuracy and accessibility. With nearly a decade of biosimilar experience, studies consistently demonstrate no loss of efficacy and robust safety profiles, as evidenced by FDA data encompassing various therapeutic areas, including oncology and immunology.

Overall, the accumulated evidence fosters confidence in biosimilar use in the United States, supporting their integration into clinical practice across a spectrum of inflammatory diseases.

Video synopsis is AI-generated and reviewed by HCPLive editorial staff.

Specialists in rheumatology, dermatology and gastrointestinal disease discuss clinical trials that have shown safety and efficacy of adalimumab biosimilars in inflammatory diseases.

A clinical pharmacist reviews the various pharmacological aspects of the available adalimumab biosimilars.

The Pharmacological Aspects of Adalimumab Biosimilars

The discussion delves into considerations regarding the concentration, citrate-free nature, and volume of adalimumab, particularly in the context of transitioning patients to biosimilars. The speaker emphasizes the importance of minimizing patient discomfort by opting for agents with smaller syringes, no citrate, and lower volume. They highlight the popularity of citrate-free products due to reduced pain and mentions that high concentration with citrate may cause less injection site discomfort. Ideally, biosimilars should offer high concentration, small needles, and be citrate-free, although not all currently meet these criteria. Various delivery mechanisms impact patient experience, necessitating education and informed choices.

The speaker adds insights from a dermatological perspective, noting patient preferences for specific pen devices and potential implications for treatment adherence. He suggests tracking patient feedback to inform future decisions. Concerns about off-label doses and the burden of multiple devices underscore the need for streamlined options to facilitate adherence.

The complexity of managing multiple devices and formulations requires extensive patient and staff education. Providers must navigate diverse product landscapes to ensure optimal treatment experiences. The discussion underscores the need for comprehensive understanding and support to facilitate informed decision-making and improve patient outcomes.

2.	Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years.

An Overview of Adalimumab Biosimilars

The discussion focuses on adalimumab biosimilars, examining their indications, mechanism of action, interchangeability, and clinical implications. Currently, there are over 40 biosimilars created for a dozen biologic products, with a focus on adalimumab. While most indications of adalimumab have biosimilar alternatives, three orphan drug indications remain unapproved for biosimilars.

The mechanism of action for adalimumab biosimilars mirrors that of the reference product, with rigorous FDA review processes ensuring structural and functional similarity. Biosimilars must demonstrate identical primary and secondary structures to reference products, differing only in tertiary and quaternary folding. Additionally, they share the same administration route and strength.

Interchangeability designation by the FDA streamlines pharmacy-level switches, but specific conditions must be met. Biosimilars must replicate clinical outcomes, maintain safety profiles, and undergo switching studies. Despite potential benefits, providers emphasize the importance of patient education and notification regarding biosimilar switches to maintain therapy continuity.

The discussion highlights the need for proactive patient communication and regulatory compliance to facilitate smooth transitions between reference and biosimilar products. Clinicians express willingness to embrace interchangeable biosimilars to reduce administrative burdens and ensure uninterrupted patient care, underscoring the importance of effective communication and documentation within healthcare systems.

Video synopsis is AI-generated and reviewed by Center for Biosimilars editorial staff.

Clinicians and a pharmacist provide an overview of the emerging adalimumab biosimilars in the recent years.

discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist reviews the regulatory requirements for biosimilar FDA approval. 

The Need for Biosimilars in Inflammatory Diseases and Regulatory Requirements for Approval

Experts discuss the role of biologic agents and biosimilars in managing chronic inflammatory diseases. The advent of biologics has significantly improved patients' lives, and biosimilars offer increased access to these therapies. With a growing array of options, practitioners are identifying and treating patients earlier in the disease progression.

The speaker highlights the importance of biosimilars, which are vital for managing formularies in large healthcare systems like Sutter Health. They emphasize the transformative impact of these therapies in dermatology and underscores the need for cost-effective solutions to broaden access.

The speaker explains the regulatory requirements for biosimilars under the Biologic Price Competition and Innovation Act (BPCIA). While biosimilars are highly similar to reference products, they cannot be substituted at the pharmacy level without physician approval. Formulary decisions within health systems help streamline prescribing practices.

Overall, the exchange emphasizes the significance of biosimilars in expanding access to effective treatments for inflammatory diseases while navigating regulatory complexities and cost considerations.

Drs Lio, Botsoglou, and Alexrad discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist Dr Humphreys reviews the regulatory requirements for biosimilars to receive FDA approval. 