The Top 5 Biosimilar Articles for the Week of April 15

 Data from 2021 and 2022 showed that biosimilar use within an 

 was on the rise, suggesting that the country could achieve total utilization in the coming years. The researchers touted the growing success, saying that more use will benefit the National Health System (NHS) and citizens who rely on an efficient and sustainable health care policy.

 Sarfaraz K. Niazi, PhD, outlines the current state of 

 in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.

 evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.

 is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.

 After poor sales for its adalimumab biosimilar, Boehringer Ingelheim (BI) announces layoffs; Teva Pharmaceuticals and mAbxience 

; Samsung Bioepis begins a phase 3 trial for a biosimilar referencing Keytruda (pembrolizumab).

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of April 15, 2024.

A clinical pharmacist discusses the role of pharmacy benefit managers and payers in accessibility of adalimumab biosimilars.

The Role of Pharmacy Benefit Managers and Payers in Accessing Adalimumab Biosimilars

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 conversation delves into the role of payers and pharmacy benefit managers (PBMs) in facilitating patient access to biosimilars. PBMs primarily manage formularies, and despite numerous biosimilar launches in the United States, uptake has been relatively low. This is attributed to formulary restrictions imposed by PBMs, leading physicians to prefer biosimilars but encountering barriers due to patient insurance guiding them towards the reference product.

However, there are signs of change, with some large PBMs beginning to cover biosimilars. The trend is encouraging, as biosimilars offer cost savings for both healthcare industries and patients. Despite this, uptake remains low, with only a 2% increase noted by the end of 2023, though there are indications of shifting towards biosimilar usage, especially in Medicare patients.

In New York, for instance, many payers are transitioning towards biosimilars, prompting the need for readiness among patients and providers for potential switches. Pressure is mounting on PBMs to improve formulary access for biosimilars, given the expanding options available and the cost-saving potential, particularly with medications like adalimumab.

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

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

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.

The Top 5 Videos for the Week of April 8

 A systematic review and meta-analysis of 7 randomized controlled trials found 

 in efficacy and safety indicators between adalimumab biosimilars and the reference product (Humira) for treatment of moderate to severe psoriasis.

 A Chinese company has expressed interest in developing a 

 (semaglutide), a popular drug used for diabetes and weight loss; Biocon and Mylan are in talks to merge their biosimilar businesses; Celltrion completed its biologic license application (BLA) for its omalizumab biosimilar candidate.

 Although tender systems are a common strategy to encourage biosimilar utilization across Europe, policies like automatic substitution are rarely utilized, according to a systematic review of 

Sarfaraz K. Niazi, PhD, outlines how President Joe Biden's 

 could impact biosimilars, including provisions to clear up confusion surrounding interchangeable products.

Here are the top 5 biosimilar articles for the week of April 8, 2024. 

The Top 5 Biosimilar Articles for the Week of April 8

Ha Kung Wong, JD.

In an interview with The Center for Biosimilars

, Ha Kung Wong, JD, an intellectual property attorney and partner at 

, dives into the advantages of the patent dance. Wong, a specialist in intellectual property law, explores how this process streamlines information exchange and minimizes unnecessary lawsuits.

The patent dance, Wong explains, establishes a framework for early disclosure of patents and potential infringement concerns between biosimilar developers and reference product sponsors. By enabling early assessment of patent validity and infringement, it empowers parties to reach settlements before product launch, saving both time and money.

This approach mirrors the Hatch-Waxman Act for traditional drugs and has demonstrably reduced litigation in the biosimilar space. Even when lawsuits become necessary, the patent dance helps focus on the most critical patents, minimizing resource expenditure for all involved.

What are the key objectives of the patent dance, and how does it contribute to streamlining the exchange of information while reducing the potential for wasteful litigation?

The patent dance allows for an early assessment of infringement and validity patient positions, even before the filing of a litigation and that can help parties reach an early settlement.

Part of the process here is don't slow down biosimilar approval process, don't subject them to damages from launching at risk. Let's resolve all the patent issues in advance or at the time in which you're looking to get approval, such so that you can get it resolved at the time you get approval.

If you don’t have a problem with the patents, then you can launch without any risk and you're okay. If you do, let's sort that out.

 does for small molecules and that's what this 

 [Biologics Price Competition and Innovation Act] patent dance does for biosimilars and it's been really effective.

I think it’s led to a great number of settlements, very few of them go to trial, which means we're not wasting resources on litigation. As much as I do litigation, so I like to have litigation, I think for my clients, it's a win-win all the way around.

Also, the case management mechanisms have been very effective at limiting the size of the litigations. For example, in the recently decided 

 relating to Eylea, despite 24 patents initially being asserted, the case was initially narrowed to set 6 patents, and then further narrowed to 3 patents for an expedited trial that provided the companies with resolution.

One patent was found valid and infringed without having to litigate all the asserted patents. I think, by and large, it’s working to really save resources for all parties involved. If it has to go to litigation, it goes but it also is resulting in favorable settlements in which everybody wins.

Intellectual property attorney Ha Kung Wong, JD, describes the patent dance and how it is designed to streamline information exchange while avoiding unnecessary lawsuits by allowing early assessment of patent infringement and validity.

Streamlined Approach to Biosimilar Approval Reduces Litigation Risk

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.

The Top 5 Biosimilar Articles for the Week of April 1

 described the totality of evidence supporting the approval of the adalimumab biosimilar AVT02 (Simlandi; Alvotech) for all approved indications of the reference product, Humira.

 Sarfaraz K. Niazi, PhD, outlines how President Joe Biden's 

The Association for Accessible Medicines’ 

 on Medicare Part D tiering revealed low coverage rates for insulin and adalimumab biosimilars across plans.

 reintroduce the Increasing Access to Biosimilars Act, a bipartisan bill aimed at boosting competition and encouraging providers to prescribe biosimilars, to Congress.

Despite more biosimilars entering the market and generating significant savings for payers and health care systems, these savings are not resulting in lower 

 for patients, according to a recent study.

Here are the top 5 biosimilar articles for the week of April 1, 2024.

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. 