Clinicians and a pharmacist discuss how they are managing access and assistance with copay assistance program in their practices.

Copay Assistance Programs for 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 experience with copay assistance programs for biosimilars, highlighting the need for effective patient support to ensure broad uptake and continued adherence. Participants note the familiarity with existing programs for originator drugs and stress the importance of replicating similar support systems for biosimilars to maintain patient confidence.

Concerns arise regarding gaps in education and communication from biosimilar manufacturers, emphasizing the necessity of comprehensive support programs and clear communication channels. Patient access to biosimilars is seen as crucial, with biosimilar adoption programs needing to address various factors such as coverage, support systems, and pharmacoeconomic considerations.

The discussion underscores the significance of accessible and efficient support systems, both for insured and uninsured patients, to facilitate biosimilar adoption. Additionally, effective communication among healthcare providers, specialty pharmacists, and patients is highlighted as essential for navigating access to these programs and ensuring optimal patient care.

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

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Healthcare providers in inflammatory diseases talk about the role they have on encouraging adalimumab biosimilar use in clinical practice.

The Role of Health Care Providers on Encouraging Adalimumab Biosimilar Use

The discussion centers on how healthcare professionals can promote the use of adalimumab biosimilars and enhance patient care. The consensus is that biosimilars offer comparable efficacy and safety to the originator drug, with improved accessibility for patients. Encouragingly, dermatologists, among others, are being urged to consider these options for their patients.

Healthcare professionals emphasize the importance of patient education and cost savings as key factors in promoting biosimilar adoption. Educating both providers and patients about biosimilars, including their regulatory approval process and safety profile, is essential for widespread acceptance. Financial considerations, such as copay savings, also play a significant role in patient decision-making.

Overall, the aim is to assure patients of the efficacy and safety of biosimilars and to equip healthcare providers with the knowledge needed to support their use effectively.

The Top 5 Biosimilar Articles for the Week of April 29. 

 Despite current challenges in biosimilar market growth due to stakeholder disagreements, a recent commentary proposes that applying 

 can achieve widespread biosimilar market uptake by fostering collaboration for long-term benefits.

 (trastuzumab-strf; HLX02), for the treatment of HER2-positive breast cancer. The approval marks the 

 for a biosimilar referencing Herceptin (trastuzumab) and first overall for the company in the US.

 annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.

 have saved the organization over $243 million between 2020 and 2023, according to Melody Chang, vice president of pharmacy operations at AON.

 summarized the totality of evidence supporting the approval of the 

 (Hyrimoz; Sandoz) in the United States and Europe.

To read all of these articles and more, visit 

Here are the top 5 biosimilar articles for the week of April 29, 2024. 

The Top 5 Biosimilar Articles for the Week of April 29

rheumatology, dermatology and gastrointestinal disease share their clinical experience on initiating or switching their patients on adalimumab biosimilars.

Clinical Experience With Initiating Adalimumab Biosimilars

The discussion revolves around experiences initiating patients on biosimilars. For bionaive patients, the process is generally smooth, often involving in-office injections to familiarize patients with administration techniques. However, stable patients may express hesitancy, primarily due to concerns about cost. Educating patients about copay programs and assisting them in enrolling in financial assistance programs can alleviate these concerns.

Transitioning patients to biosimilars can be challenging, especially concerning logistical issues like insurance coverage and medication delivery. Clear communication and proactive enrollment in support programs are essential to prevent treatment interruptions.

Patient education is crucial to address concerns and dispel misconceptions, particularly regarding the nocebo effect. Consistency in messaging across healthcare staff is emphasized to build patient confidence.

Practical strategies for patient education include using lay language, keeping explanations concise, and repeating key information to reinforce understanding. Healthcare professionals also play a vital role in promoting biosimilar use and improving patient care through ongoing education and support.

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

Specialists in rheumatology, dermatology and gastrointestinal disease share their clinical experience on initiating or switching their patients on adalimumab biosimilars.

rheumatology, dermatology and gastrointestinal disease discuss the evidence on efficacy and safety on switching patient to an adalimumab biosimilar.

Switching From Adalimumab to a Biosimilar

An expert discusses the safe transition of patients from a reference product to a biosimilar. He emphasizes that although biosimilars may not be identical, they are sufficiently similar in every parameter. The primary concern during transition is ensuring coverage, as issues with insurance approval can disrupt medication supply. Preparing samples and ensuring insurance approval beforehand can prevent such interruptions.

Proactive patient education is crucial, as the speaker’s practice informed stable patients in advance about potential manufacturer switches. This preemptive communication helped patients anticipate changes and maintain confidence in the effectiveness and safety of the new product.

Another physician emphasizes the importance of patient education, particularly regarding the "nocebo effect" associated with biosimilars, which can lead to unnecessary treatment withdrawal. Educating patients about potential logistical challenges and reassuring them about product safety is essential.

Consistent education across all healthcare staff is emphasized to build patient confidence and prevent misinformation. Patient concerns about efficacy and safety can be addressed by reviewing clinical data and reassuring them of the equivalence of biosimilars to reference products.

Logistical challenges, such as ensuring timely medication delivery, are highlighted as critical for patient safety, as interruptions in treatment could lead to loss of disease control. Bridging programs and support services can help mitigate these logistical concerns and ensure continuity of care during transitions.

Specialists in rheumatology, dermatology and gastrointestinal disease discuss the evidence on efficacy and safety on switching patient to an adalimumab biosimilar.

Adam Colborn, JD. 

Adam Colborn, JD, director of government relations for the Academy of Managed Care Pharmacy, explores the efforts policymakers can take towards interchangeability and ultimately remove switching study requirements altogether. Colborn delves into the different regulations the US and Europe have when it comes to biosimilars. He stresses the importance in equipping pharmacists with proper educational resources and training that ensures confidence among biosimilar interchangeability.

Colborn presented his session titled, "Breaking Boundaries with Interchangeable Biosimilars: The Sequel", at 

the Academy of Managed Care Pharmacy (AMCP) 2024

 annual meeting, where he discussed the regulatory landscape of interchangeable biosimilars, their outcome on formulary management and benefit design, as well as emerging regulatory trends. Operating as the director of government relations, Colborn has led advocacy and state policy work through his support of AMCP's direct federal Congressional lobbying. His professional experience in public policy and professional advocacy has allowed Colborn to work on both state and federal levels.

What should policymakers keep in mind as they work to clarify interchangeability or make efforts to remove switching study requirements or the designation altogether?

I think the most important thing for regulators and policymakers to keep in mind as they're looking at potentially eliminating switching studies from the requirement to designate a biosimilar as interchangeable is how that's worked out in Europe.

There's some data that's come out recently from Europe that switching studies do not offer any additional information beyond the typical interchangeable, interchangeability application process. So that extra step really seems to be an unnecessary hurdle to the process. I think I would look at what other countries, mainly Europe, have done in that space before.

Pharmacists play a crucial role in dispensing interchangeable biosimilars. How can we ensure they are equipped with the necessary knowledge and training to confidently counsel patients on biosimilar interchangeability?

I think pharmacists, like other types of providers, need additional education on the biosimilar issue. Right now, the legal framework for biosimilar interchangeability is very complicated. For example, a biosimilar that is interchangeable with the reference product is not automatically interchangeable with another biosimilar. That's been a big obstacle for uptake of biosimilars because when we look at generic switching, it's much easier for someone to say well, I have X generic in stock so I'll dispense that instead of Y generic.

With biosimilars, they don't have that flexibility. In addition to the education to make pharmacists more comfortable with biosimilar interchangeability and switching, I think policymakers need to step in and take a role in clarifying when a biosimilar can be switched for another biosimilar that has been designated as interchangeable with the reference product.

In an interview with Adam Colborn, JD, director of government relations for the Academy of Managed Care Pharmacy focuses on biosimilar interchangeability and approaches to encourage wider adoption in dispensing these medications. 

Adam Colborn Reviews Biosimilar Interchangeability Requirements, Advocates for Pharmacist Resources

The Top 5 Biosimilar Articles for the Week of April 22

 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.

 (tocilizumab-aazg) was the second tocilizumab biosimilar to be FDA approved, but it is the first to launch in the US.

 Alvotech’s Selarsdi (ustekinumab-aekn), a 

 (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.

, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.

 in the American Oncology Network (AON) have saved the organization over $243 million between 2020 and 2023, according to Melody Chang, vice president of pharmacy operations at AON.

Here are the top 5 biosimilar articles for the week of April 22, 2024. 

Ha Kung Wong, JD. 

In this interview for The Center for Biosimilars

, specializing in patent law, discusses patent thickets and their impact on biosimilar development. Patent thickets are formed when a company obtains a large number of overlapping patents related to a single product, making it difficult for competitors to develop similar products without infringing on those patents.

Wong acknowledges the importance of patents for rewarding innovation in biologics, but also emphasizes the need for balance. Patent thickets can create barriers to biosimilar entry, which could limit patient access to these more affordable medications. Fortunately, there are mechanisms in place to mitigate this, such as terminal disclaimers and post-grant reviews, which help ensure only high-quality patents are granted and prevent unfair competition.

How are “patent thickets” formed, why are companies allowed to create them, and what needs to be done to ensure that the supplemental patent system does not block biosimilar competition and disincentivize innovation?

I think that what we're talking about here when we say "patent thickets" are larger patent portfolios that have significantly overlapping patent rights that make it more challenging for competitors to design around than for instance, a single patent. Now, for biologics, these may be created by obtaining a number of different types of patents that cover a product.

For example, there may be patents that cover the antibody, then the formulations of the antibody, methods of using the drug, ways that drugs are manufactured, devices for administration of the drug, a lot of times biologics require injections so that's oftentimes important or even ways of packaging the drug.

Now, because 1 or more patents can be obtained within each of these patent types, different aspects of a drug and it's manufacturer can end up being covered by a number of different patents. Therefore, you have this grouping of patents but keep in mind that often in development of biologics products, it's unclear early on what the commercial product will be.

Since patents are first to file in the United States, biologics innovators typically file composition of matter patents early, because they have to reserve their rights. That's usually way before they have an idea of what the specific active moiety will be that goes into clinic and certainly before knowing what the active moiety will be in the product that's made available to patients.

Additional patents are typically filed later in the development process, when the moiety becomes clear and when the formulation and method of treatment are developed, which could be way after the initial drug discovery is completed.

Interestingly, a recent study, I believe it was the 

, noted that the effective patent life for a patent and a product is about 12 years.

The effective patent life is essentially the time from drug approval to expiration, not the time that you file it. So you notice that that's not the 20 years you normally get from a patent, it's much less. If a biologic innovator wants patent protection that exceeds the BLA [biologics license applications] regulatory exclusivity from the FDA, which is itself 12 years, they typically file later patents that cover other aspects of their product beyond simple composition of matter.

There's certainly some balance that has to be struck here, as we also don't want to unduly inhibit the ability of biosimilars to reach the market and potentially increase accessibility to patients. I think we have to be kind of vigilant about that kind of give and take. There are already some systems in place to prevent unfairly blocking competition, such as the use of terminal disclaimers and skinny labeling, which allows biosimilars to enter the market for some unpatented indications while removing the patented indications from their labels.

In addition, the FDA and USPTO [United States Patent and Trademark Office], have collaborated a lot and discuss about how to make sure only good patents are allowed. I think that also the use of PGRs [post-grant reviews] and IPRs [inter partes reviews] by biosimilar manufacturers have kept a lot of innovators honest in terms of the patents that they seek to procure. So there's a number of things that are in place but we have to be vigilant about it.

Ha Kung Wong, JD, a patent attorney, explores the challenges of "patent thickets" in the biologics market, where a complex web of patents can hinder development of more affordable biosimilar drugs. However, the discussion also highlights mechanisms to ensure fair competition and patient access.

Navigating the Patent Thicket: Balancing Innovation, Biosimilar Access in the Biologics Market

rheumatology, dermatology and gastrointestinal disease talk about how they are selecting between various adalimumab biosimilars available for their patients.

Selecting Between Adalimumab Biosimilars for Your Patients

The discussion revolves around how to choose the appropriate biosimilar for patients. In dermatology, options are limited, especially for conditions like psoriasis where newer treatments may outperform existing biosimilars. However, for conditions like hidradenitis, where choices are scarce, biosimilars offer a straightforward solution. The growth of biosimilars is anticipated to provide more options for clinicians, allowing them to select treatments based on efficacy and patient insurance coverage.

Clinicians often consider insurance formularies to anticipate the most easily approved biosimilar for each patient. In conditions like inflammatory bowel disease (IBD), certain biologics like Adalimumab play a significant role in treatment, leading to the proliferation of biosimilars. While payer preferences often influence prescribing decisions, clinicians prioritize factors like citrate-free formulations, small volume, high concentration, and robust patient support programs when choosing biosimilars, aiming for broader uptake and patient adherence.

Providers in rheumatology, dermatology and gastrointestinal disease talk about how they are selecting between the various adalimumab biosimilars available for their patients.

rheumatology, dermatology, and gastrointestinal disease share strategies in how to increase the uptake of adalimumab biosimilar among providers.

Strategies to Increase Adalimumab Biosimilar Uptake in Clinical Practice

The conversation explores strategies to enhance the uptake of biosimilars, focusing on easing administrative burdens and improving patient access and affordability. Locally, initiatives have been implemented to streamline processes, such as eliminating prior authorizations for renewals of certain medications like adalimumab and reducing copayments for patients. These measures have positively impacted biosimilar uptake in the area.

Strategies for improving uptake include ensuring cost savings for patients, expanding formulary coverage to include more interchangeable products, and enhancing patient education. Patient support programs, including co-pay assistance cards and reimbursement specialists, play a crucial role in promoting biosimilar adoption, especially among Medicare and Medicaid patients. Access to these programs influences treatment decisions alongside considerations of safety and efficacy.

The conversation underscores the importance of balancing cost-saving measures with patient affordability and accessibility. It highlights the complexities clinicians face when navigating the healthcare landscape, where expensive branded medications may be accessible due to support programs, while cheaper alternatives like biosimilars remain out of reach for some patients. Ultimately, addressing these challenges requires a multifaceted approach that considers both systemic cost-saving measures and individual patient affordability.

A clinical pharmacist and specialists in rheumatology, dermatology, and gastrointestinal disease share strategies in how to increase the uptake of adalimumab biosimilar among providers.