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 

To read all of these articles and more, visit 

Videos

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.

This transcript has been lightly edited for clarity.

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.

How Strategic IDNs Boost Biosimilar Adoption

Here are the top 5 biosimilar articles for the week of November 4, 2024. 

 to clarify biosimilar safety, efficacy, and interchangeability, stakeholders can foster trust, improve access, and ensure that biosimilars are widely accepted as high-quality, cost-effective alternatives to originator biologics.

 highlights challenges to the sustainability of infused biosimilars in the US, citing rebate walls and reimbursement policies, and proposes key solutions to enhance adoption and benefits for all stakeholders.

 found that the rising prevalence of inflammatory bowel disease (IBD), approaching 1% in Europe and North America, is accompanied by increasing healthcare costs due to shifts in care and higher hospitalization expenses, presenting challenges to sustainability and prompting strategies for personalized, cost-effective care.

 the need for transparency and policy reforms in pharmacy benefit management (PBM) to improve accessibility, affordability, and fair competition for adalimumab biosimilars.

: An article by Sarfaraz K. Niazi, PhD, argues that the FDA’s classification of future copies of messenger RNA (mRNA) products 

, suggesting they might be eligible for new drug applications (NDAs) or a hybrid biosimilar category due to their unique characteristics and increasing prevalence.

The Top 5 Biosimilar Articles for the Week of November 4

Here are the top 5 biosimilar articles for the week of October 28, 2024. 

: At the GRx+Biosims conference, a fireside chat highlighted the need to 

streamline biosimilar development and strengthen industry collaboration

, with Sarah Yim, MD, of the FDA, emphasizing education's key role in building trust and adoption.

: Regulatory experts and representatives from some of the top biosimilar manufacturers emphasized the importance of global harmonization and streamlining biosimilar development 

, panelists explored challenges and progress in biosimilar interchangeability regulations in the US, discussing the FDA's new draft guidance, the removal of switching study requirements, and the need for more education to reduce misinformation and improve biosimilar uptake.

: During a fireside chat at GRx+Biosims, FDA Commissioner Robert Califf, MD, shared his perspective on key challenges and sustainability concerns in the generic drug industry, touching on pressing issues within the 

US health care system and broader global supply chain vulnerabilities

 key insights into biosimilar device requirements, emphasizing risk analysis, human factors studies, and alternative validation approaches to streamline regulatory approval for interchangeable biosimilars, while maintaining patient safety and efficacy, at the 