Here are the top 5 biosimilar articles for the week of December 16, 2024. 

 The impact of pharmaceutical companies' 

 on the adoption of trastuzumab biosimilars in the Netherlands led to significant price reductions and increased market share.

 found patient satisfaction was stable after switching from either the reference product or a low-concentration adalimumab biosimilar to the adalimumab biosimilar CT-P17, a high-concentration, citrate-free formulation.

 (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.

 The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and 

increases costs for biosimilar competition

submitted a European marketing application

 for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab biosimilar.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of December 16, 2024.

The Top 5 Biosimilar Articles for the Week of December 16

Elie Bahou talks IDNs and biosimilars 1

In an interview, Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, outlined key barriers to biosimilar adoption within integrated delivery networks (IDNs) and strategies to overcome them. He highlighted provider apprehension and operational hurdles, such as electronic medical record challenges, as significant obstacles.

Bahou also emphasized the importance of strategic payer collaborations, flexible contract terms, and patient and provider education to enhance access to high-cost biologics, reduce disparities, and improve adherence through clear communication of treatment benefits and outcomes.

This transcript has been lightly edited for clarity.

What are the specific barriers to biosimilar adoption within IDNs, and how can IDNs incentivize physicians and pharmacists to prescribe biosimilars over originator biologics?

That's a good question. Doctors typically memorize 10 to 12 medications they're comfortable with. They like to prescribe them over and over. They have the names, they know the side effects, etc. So it's hard to break habits with doctors, as you can imagine. So I would say that provider apprehension or doctor/physician apprehension is there, and we need to educate them on the obstacles of implementing and switching, and the positive aspects of switching. The fact that they're similar drugs called biosimilars, and they save us sometimes 60% of the actual price [of the originator]. And then operational or technical barriers are also some of the challenges with respect to our EMR (electronic medical record) called Epic. 

Even though a doctor prescribes a drug, if the payer, meaning the PBM (pharmacy benefit management) company, does not have that drug biologic on the formulary, they won't pay for it. So that's another complication. How do we mitigate that? We just engage the providers, as I said, to get them comfortable and make them understand the importance of these biologics. We work with the organizational P&T [pharmacy and therapeutics] committee to facilitate adoption of these biologics and to help guide [providers] on prescribing them. 

Then, we use our clinical informatics team to ensure a seamless adoption of these biosimilars, and then we work closely with the manufacturers that make these biologics to bring additional value through contracting. So, those 4 ways are how we mitigate that.

What changes in pharmacy benefit design could lead to a more equitable balance between patient cost-sharing and access to high-cost biologic medications?

Good question. I think one of the best ways to do it is to just develop strategic partnerships with these drug manufacturers by negotiating pricing based on volume purchases, which is what they want, and on outcome. So that includes flexible type of contract terms that allows us to revisit the value and the volume more often to adjust according to market dynamics and payer coverage and then [we have more input with] engagement and policymakers and professional organization for policy type of advocacy. 

So we have a whole government affairs team that really works very hard and lawyers and advocates that work in Washington, DC, to help us with that. And then, provider education—educate the health care providers in our system on the latest evidence-based type of practices to help them pick which biological that's more cost-effective to use for the best optimal outcomes. That's pretty much it. We educate our patients. We make sure that they are aware and understand what the therapy is used for, including potential benefits as well as side effects to enhance their adherence to their medication and their willingness to take it. That's pretty much it in a nutshell.

Elie Bahou, PharmD, senior vice president and system chief pharmacy officer at Providence, discussed barriers to biosimilar adoption and highlighted strategies such as physician education, streamlined implementation, payer collaboration, and patient engagement to improve access, reduce costs, and enhance adherence to biologic therapies.

Strategies for Improving Biosimilar Access and Utilization

Here are the top 5 biosimilar articles for the week of December 9, 2024. 

: Alvotech and Advanz Pharma have submitted a European marketing application for their golimumab biosimilar to treat inflammatory diseases, while Celltrion secured Korean approval for denosumab biosimilars, and Intas Pharmaceuticals partnered with Xbrane Biopharma on a nivolumab 

 (ustekinumab-kfce), the sixth biosimilar to reference Stelara (ustekinumab) for the treatment of inflammatory bowel disease, plaque psoriasis, and psoriatic arthritis.

 found that the adalimumab biosimilar SB5 was effective in treating rheumatic or gastrointestinal immune-mediated inflammatory diseases, showing no loss of disease control in switched patients and similar persistence rates between naive and switched groups.

Veterans with inflammatory bowel disease (IBD)

 prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.

, with increased payer preference and market share, leading to significant price reductions and evidence of a competitive market from 2017 to 2022, according to a 

The Top 5 Biosimilar Articles for the Week of December 9

steve pickette talking about biosimilars and AI

Steve Pickette, PharmD, BCPS, chief clinical pharmacist at InpharmD, highlighted the transformative role of artificial intelligence (AI) in managing biosimilars and generics. He explains that AI can significantly reduce the workload for clinical and pharmacy staff by streamlining the analysis required for prescribing and formulary changes, enabling better engagement with health care providers. Additionally, AI enhances pharmacovigilance by monitoring formulary changes, tracking adoption rates among providers, and identifying potential issues.

How can AI help with the prescribing of biosimilars and generics and, can it aid in pharmacovigilance of these products?

Yes, it can aid in prescribing, in reducing the overhead burden of doing the analysis and free up the pharmacy drug information services or clinical staff to engage with the providers. And change management is always a big part of the formulary process—really the most challenging part and it seems like we never have the time to do it. And you get the analysis together as part of the P&T [Pharmacy and Therapeutics Committee], and you get it out there for the doctors, but I rarely would have the time to really engage them and go over it and look at it. So, it really aids in the process in that way.

And then you mentioned the vigilance of seeing how things have gone. That is another area where we never seem to have time. You do a formulary interchange, you've gone through the whole process, you've made the change, and you move to a different product, and then you move on to the next evaluation. And so it's always a kind of a stressor in the back of our minds for those of us that manage formularies. Is it still going okay? Has something changed? I think that's a big benefit of the use of AI-assisted analytic tools, such as what we've built, is it will track and alert you if something has changed or tell you that it's doing well and let you know how things are going. For example, there's a certain set of providers that aren't adopting it. That's another medication use evaluation process that's really challenging, labor-intensive, and time-consuming. So, [this technology] is really promising in all those regards.

Steve Pickette, PharmD, BCPS, emphasizes that AI can streamline prescribing and formulary management for biosimilars and generics, enhance provider engagement, and improve pharmacovigilance by tracking adoption rates and identifying potential issues.

AI-Powered Solutions for Streamlining Biosimilar Prescribing and Monitoring

Here are the top 5 biosimilar articles for the week of December 2, 2024. 

 of affordable biosimilars, with varying impacts across different jurisdictions.

 that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.

 (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

 have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.

The Top 5 Biosimilar Articles for the Week of December 2

The top 5 biosimilar articles for the week of November 25, 2024. 

, an anti-HER2 antibody, to HLX02 biosimilar and XELOX (oxaliplatin and capecitabine) chemotherapy extended progression-free survival (PFS) in patients with untreated HER2-positive advanced gastric cancer. 

 introduced by Japan's 2022 health policy did not result in a reduction in overall drug costs, biosimilar use in oncology significantly increased.

 Biosimilars could improve access to biologic treatments and health care sustainability in 

, but their adoption is hindered by misconceptions, regulatory gaps, and weak pharmacovigilance, requiring targeted education and stronger regulations.

 grants marketing authorization to 2 aflibercept biosimilars; Biosimilars Canada launches new campaign to provide sustainable solutions to employers; Celltrion shares positive data for 2 biosimilars.

 were recognized in the US, we have only 16 products as multiple biosimilars, while more than 100 molecules await entry. This disappointment is highly touted by the associations as a great success, quoting that adopting biosimilars saves money—this was expected, but how little this saving is rarely mentioned. 

Here are the top 5 biosimilar articles for the week of November 25, 2024. 

The Top 5 Biosimilar Articles for the Week of November 25

The Top 5 Biosimilar Articles for the Week of November 18

: In 2 randomized controlled trials of maintenance therapy for inflammatory bowel disease (IBD), the subcutaneous formulation of the 

 demonstrated superiority to placebo in patients with Crohn disease and ulcerative colitis.

: Biosimilars hold the potential to dramatically 

lower health care costs and improve access

 to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.

 for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.

 for Global Biosimilars Week dives into the complexities of payer and pharmacy benefit manager (PBM) policies, how they impact biosimilar accessibility, and how addressing these issues may look under a second Trump term.

 for Global Biosimilars Week, penned by Dracey Poore, director of biosimilars at Cardinal Health, explores the critical topic of interchangeability, examining its role in shaping biosimilar adoption and the broader implications for accessibility.

Here are the top 5 biosimilar articles for the week of November 18, 2024. 

global biosimilars week webinar

 was hosted by The Center for Biosimilars

 in partnership with the International Generics and Biosimilars Association.

Global Biosimilars Week (GBW) 2024 is an annual campaign designed to raise global awareness about biosimilar medicines and their role in improving patient care and access to affordable treatment options.

This year’s theme, "Advancing Access to Biosimilars," focuses on the progress made over the past two decades surrounding approval, market acceptance and adoption of biosimilars—as well as the challenges that remain in expanding access worldwide. With an effort to highlight the importance of collaboration among health care professionals, patients, stakeholders, and policymakers, the webinar will focus on 

 to advance access to biosimilars and will feature expert discussions on the key barriers to biosimilar uptake in different regions and explore strategies to overcoming these obstacles.



Current global trends in streamlining biosimilar regulatory requirements to foster efficient adoption and market growth.

Strategies to address challenges and improve biosimilar access.

The role of biosimilars in promoting health care sustainability and better patient outcomes.

, assistant managing editor of The Center for Biosimilars (host)

, senior vice president of sciences and regulatory affairs, Association for Accessible Medicines (moderator)

, PhD, Executive Director for Products Evaluation and Standards Setting, Saudi Food and Drug Authority

, PhD, scientist, technical standards and specification unit group lead, norms and standards for biologicals, Health Product Policy and Standards/Medicines and Health Products/World Health Organization 

enior quality specialist, European Medicines Agency

, director, Office of Therapeutic Biologics and Biosimilars Office of New Drugs, Center for Drug Evaluation and Research, FDA

This webinar celebrating Global Biosimilars Week was hosted by The Center for Biosimilars® in partnership with the International Generics and Biosimilars Association.

Webinar: Streamlining the Regulatory Process to Advance Access to Biosimilars

Here are the top 5 biosimilar articles for the week of November 11, 2024. 

: Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require 

, market competition, and better education for both providers and patients.

 on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.

: Celltrion plans to commercialize 22 biosimilars by 2030, expanding its global presence with 

 driven by core biosimilars and new launches like subcutaneous infliximab.

: For the first time, Skyrizi (risankizumab-rzaa) has 

 (reference adalimumab) as AbbVie’s sales driver, largely due to companies encouraging “product hopping” to avoid competition, creating concerns for the sustainability of the burgeoning adalimumab biosimilar market.

The Top 5 Biosimilar Articles for the Week of November 11

Sophia Humphreys, PharmD, talks about biosimilars

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, explains that biosimilar adoption relies on clear strategies in the "buy and bill" medical benefit space. Successful integrated delivery networks (IDNs) collaborate with group purchasing organizations (GPOs) and 340B programs, regularly assess cost factors, and integrate biosimilar tools into electronic health records (EHRs) to simplify prescribing for physicians. Prior authorization processes for both biosimilars and reference products also streamline care. Regular performance reviews and sharing results with leadership help drive continuous improvement in biosimilar uptake.

First, Humphreys notes that we need to differentiate between medical benefit and pharmacy benefit. Many of the most successful biosimilars are in the medical benefit space, especially in the "buy and bill" space. IDNs that work closely with GPOs, 340B branches, and formulary management teams perform regular reviews of coverage, patient mix, and average sales price vs acquisition cost. These analyses help them decide which biosimilars to prioritize. 

Additionally, some IDNs have built biosimilar tools into their EHR systems to streamline physician workflows. Physicians are extremely busy and can’t be expected to remember which product to use each quarter, so it’s important to build support into the system. Some IDNs have also incorporated prior authorization processes for both the reference product and biosimilars, further streamlining care. Finally, it’s crucial to conduct regular performance reviews and share success metrics with leadership. This continuous improvement process elevates the entire system.

Sophia Humphreys, PharmD, MHA, BCBBS, director of system formulary management at Sutter Health, discusses how integrated delivery networks (IDNs) can help drive biosimilar adoption.