Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

The US pharmaceutical market is the largest globally, with high drug spending and profitability, influenced by market competition rather than government pricing controls.

The 340B program's effectiveness is questioned, with states enacting laws to ensure discounted drug sales to contract pharmacies, amid unclear financial benefits for patient care.

Legal actions against PBMs target anticompetitive practices, aiming to reduce drug prices and improve transparency, prompting a shift towards more transparent PBM models.

Biosimilars and transparent pricing models, like Mark Cuban's Cost Plus Drug Company, are disrupting traditional drug pricing, enhancing affordability and accessibility for patients.

This article was originally published on 

As National Pharmacist Day approaches on January 12, the nation will celebrate the invaluable contributions of these dedicated professionals who play a vital role in our health care system.

 The industry braces for a transformative year as 2025 promises a landscape reshaped by political shifts, legal battles, and innovative models, all while grappling with the ever-rising cost of prescription drugs.

While the industry faces scrutiny over drug pricing and distribution models, innovative approaches like the rise of biosimilars and the emergence of transparent pricing models offer hope for a more affordable and accessible future for patients.

Over the past year, CMS predicted prescription drug spending in the US would reach around $460 billion, not including nonretail drugs.

 Compared with other countries, the US has the highest drug spending and the greatest per capita pharmaceutical spending among developed countries. While other countries allow the government to control drug pricing, the US leaves the drug pricing up to market competition. As a result, the US market is the most profitable among pharmaceutical companies.

The US accounts for 30% to 40% of the global market, 45% of global pharmaceutical sales, and 22% of global production.

 The Affordable Care Act (ACA) has increased the industries’ profitability largely since its implementation. The ACA ensures specific small businesses, often persuaded through eligible tax credits, are offering a form of health insurance to their employees.

The 340B drug discount program is a part of the ACA that urges pharmaceutical companies that participate in Medicaid to sell outpatient drugs at discounted prices to clinics, community health centers, and hospitals that primarily serve low-income patients.

 The initiative was intended so that providers would use the money saved to expand their services, but instead it is believed they are pocketing the profits instead of investing. Most facilities did not have in-house pharmacies, leaving “contract” pharmacies to dispense the drugs eligible for patients on behalf of their health centers and hospitals.

In 2020, several major pharmaceutical manufacturers announced they would restrict 340B drug sales to contract pharmacies only. However, this past year, various states have enacted laws that require drug manufacturers to participate in selling discounted drugs to contract pharmacies. Due to the relaxed expectations of the 340B reporting requirements, it is unclear if the money is being used to improve patient care.

The pharmaceutical landscape enters 2025 with a mix of challenges and opportunities, with the potential to shapes the future of drug access and affordability for patients across the nation. | Image Credit: Africa Studio - stock.adobe.com

Pharmacy regulation under a second term of President-elect Donald Trump, a Republican Congress, and state-level pharmacy policies based on Republican public policy momentum may have longstanding impacts on the industry.

 During Trump’s first term, Congress established the Know the Lowest Price Act and the Patients’ Right to Know Drug Prices Act, looking to increase transparency and reduce patient out-of-pocket costs. Aside from these achievements, the Trump administration was unable to fulfill the American Patients First blueprint by the conclusion of the first term. The second Trump term is expected to lean on conservative right-wing think tanks like the America First Policy Institute, the Heritage Foundation, and the Paragon Health Institute.

Additional changes from the Federal Trade Commission (FTC) set out to reform pharmacy benefit manager (PBM) practices.

 The FTC filed a lawsuit against PBMs for anticompetitive practices and artificially raising prices. The suit claims Optum Rx, Express Scripts, and CVS Caremark—all integrated with UnitedHealth Group—made patients pay more for their medications and engaged in supply chain competition. 

Claims have been made that PBMs favor high rebates from manufacturers and intentionally exclude lower list price drugs because it leads to higher profits for companies. The FTC alleges that rebates are used to attract payers, employers, unions, and other insurers. The lawsuit aims to reduce list prices of certain drugs, eradicate central formulary design and rebate practices, while lowering health premiums for beneficiaries.

Based on these legal threats, some large employers have switched from traditional PBMs to newer upstarts.

 Over the course of 2025, more employers are expected to move to more transparent PBM models. With many employers communicating their dissatisfaction and the FTC’s lawsuit at hand, the future trends look to resolve areas that do not reflect client or patient needs.

Biosimilars will also continue to disrupt the drug market as they offer more affordable alternatives to high-cost biologics. For the past 5 years, the American biologics market grew by an average of 12.5% annually, with 46% of total spending accounting for biologics. When adalimumab (Humira) biosimilars launched onto the market, significant cost savings were a direct result. However, the traditional PBM model and the nation’s 3 largest PBMs interrupted adoption rates. Once CVS Caremark removed Humira from its formulary in April, adoption of biosimilars grew.

Mark Cuban’s Cost Plus Drug Company is positioned for impact in 2025 as it works directly with drug manufacturers to bypass middlemen and lower medication prices.

 Cuban’s plan aims for transparency and disrupts generic drug pricing to sell about 2500 medications with a growing partnership of health systems. The company currently works with Rightway, EmsanaRx, RxPreferred Benefits, and PCA Rx. Most recently, Cuban’s company partnered with Coherus BioSciences to sell a biosimilar version of AbbVie’s Humira.

Blue Shield of California and Capital Blue partnered with the Cost Plus Drug Company along with Amazon Pharmacy, Abarca, and Prime Therapeutics. Cuban’s approach seems to be impacting pharmacy giants like CVS and Walgreens, who are now following Cost Plus’ blueprint to offer transparent drug pricing.

As 2025 unfolds, the pharmaceutical industry must navigate a complex landscape to ensure that patients have access to affordable and effective medications, while addressing pricing pressures, regulatory changes, and the rise of new care delivery models.

National pharmacist day. NASPA. 2024. Accessed January 6, 2025. 

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US pharmaceutical market size to reach USD 1,093. 79 billion by 2033. BioSpace. July 12, 2024. Accessed January 3, 2025. 

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How the patient protection and affordable care act affects pharmacies. Brown and Fortunato PC. January 20, 2017. Accessed January 3, 2025. 

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Chatlani S. States force drugmakers to keep selling cheaper meds under federal program. Stateline. August 28, 2024. Accessed January 3, 2025. 

Schnelle SJ, Hyun J. Post-election outlook: issues to watch for pharmacy industry stakeholders. NatLawReview. December 10, 2024. Accessed January 3, 2025. 

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Tong N. FTC formally sues PBMs over insulin prices and warns manufacturers. Fierce Healthcare. September 20, 2024. Accessed January 3, 2025. 

https://www.fiercehealthcare.com/payers/ftc-formally-sues-pbms-over-insulin-prices-and-warns-manufacturers

Tong N. 2025 outlook: alternative PBMs look to heap pressure on industry titans. Fierce Healthcare. December 16, 2024. Accessed January 3, 2025. 

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Garduno S. Top 4 PBM trends to watch in 2025 and beyond. Xevant. December 11, 2024. Accessed January 3, 2025. 

https://www.xevant.com/blog/updated-pbm-trends/

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https://www.fiercehealthcare.com/health-tech/mark-cuban-wants-keep-shaking-healthcare-heres-cost-plus-drugs-next-move

Articles

The pharmaceutical landscape enters 2025 with a mix of challenges and opportunities, with the potential to shape the future of drug access and affordability for patients across the nation.

The Future of Pharmacy: Trends, Threats, Transformations

The top 5 biosimilar articles for the week of February 3, 2025

 demonstrated clinical biosimilarity to reference ustekinumab after switching and maintained long-term comparable efficacy and safety up to week 52.

, a tocilizumab biosimilar developed by Celltrion, for the treatment of several rheumatic conditions. It is the third biosimilar to reference Actemra (tocilizumab) to be approved for US patients.

 demonstrates long-term safety and efficacy comparable with the reference product Soliris in patients with paroxysmal nocturnal hemoglobinuria (PNH), according to a Russian study that expanded on a previous phase 3 study.

 referencing Stelara (ustekinumab) in the US, ushering in a new class of lower-cost medicines for patients with rheumatic and gastrointestinal conditions.

 redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of February 3, 2025.

The Top 5 Biosimilar Articles for the Week of February 3

Enzeevu (aflibercept-abzv), a biosimilar developed by Sandoz, demonstrated biosimilarity to reference aflibercept (Eylea) in patients with neovascular age-related macular degeneration (nAMD). | Image Credit: Orawan - stock.adobe.com

Enzeevu (aflibercept-abzv), a proposed biosimilar from Sandoz, matched reference aflibercept (Eylea) in efficacy, safety, and pharmacokinetics among patients with neovascular age-related macular degeneration (nAMD), according to a study published in 

Inflammation, oxidative stress, and neovascularization of the retinal and subretinal spaces are symptoms of the chronic, progressive eye disease. Reduced vision loss and optimized visual quality of life are the overall treatment goals. The most benefits are seen when treating nAMD early, continuous, and timely. 

More treatment options have been presented with the approval of anti–vascular endothelial growth factor (VEGF) biologic therapies like aflibercept, ranibizumab, brolucizumab, and faricimab. The aflibercept biosimilar, Enzeevu, is the fourth biosimilar referencing Eylea, having received approval in August 2024.

Enzeevu was granted interchangeability status, which allows it to be substituted in place of the reference aflibercept at the pharmacy level without provider permission.

The approval of aflibercept-abzv was based on the Mylight study (

), a phase 3, prospective, double-masked, 2-arm, parallel trial.

The primary outcome was the average change from baseline in best-corrected visual acuity (BCVA) at week 8 of treatment between reference aflibercept and aflibercept-abzv. The secondary end points were anatomical outcomes, BCVA at weeks 24 and 52, safety, immunogenicity, and pharmacokinetics.

Participants were randomized across 103 sites in 16 countries across North America, Europe, Asia, and Australia for a 52-week study duration. There were 485 total participants who were randomized to receive either the Sandoz aflibercept (n = 245) or Eylea (n = 240).

At week 8, researchers observed a treatment difference in mean change from baseline in BCVA in the per-protocol set. The study showed a mean of –0.3 (90% CI, –1.5 to 1), which fell within the predefined FDA and European Medicines Agency equivalence margins (–3 and 3, and –3.5 and 3.5, respectively). The study results demonstrated comparable mean changes in BCVA scores between treatment groups at all other timepoints up to week 52. Comparable proportions of patients maintained vision in both the aflibercept-abzv and reference aflibercept groups (16.7% and 17.2%, respectively).

Additionally, the proportion of patients with moderate visual gains was comparable between aflibercept-abzv (20.3%) and reference aflibercept (23.8%). By week 52, intraretinal fluid was observed via optical coherence tomography in 23.9% of participants receiving aflibercept-abzv compared with 24.3% of those receiving reference aflibercept.

Similar rates of participants experienced at least 1 treatment-emergent adverse event (TEAE) in the aflibercept-abzv (73.4%) and reference aflibercept groups (72.5%). The frequency of TEAEs was also similar between the biosimilar aflibercept-abzv (2.5%) and the reference product (2.9%). TEAEs caused treatment discontinuation in 4.5% of the biosimilar group and 3.3% of the reference drug group. The rate of serious AEs was minimal and similar in both the biosimilar (16%) and reference product treatment arms (12.5%).

Although both groups included participants with preexisting antidrug antibodies (ADAs), most participants in both groups remained ADA negative throughout the study. Every participant who became ADA positive had also developed neutralizing antibodies. Systemic free aflibercept concentrations 24 hours post dose were low and comparable between both treatment groups.

The study included mainly White European or American participants, resulting in limited racial and ethnic diversity, which potentially limits the results. The data also confirmed safety and efficacy of aflibercept-abzv up to a maximum of 52 weeks, leaving the long-term results 1 year post treatment unconfirmed. However, the equivalence between the drugs demonstrates the expected alignment in long-term treatment response.

The proposed biosimilar aflibercept expands access to anti-VEGF treatments for nAMD, aiming to improve outcomes and reduce drug costs for patients and health care systems amid a growing patient population.

“Proposed biosimilar aflibercept represents a proposed biosimilar medicine to reference aflibercept that may play a future role in supporting optimized care for patients with nAMD,” study authors concluded.

1. Bordon AF, Kaiser PK, Wolf A, et al. Efficacy and safety of the proposed biosimilar aflibercept, SDZ-AFL, in patients with neovascular age-related macular degeneration: 52-week results from the phase 3 mylight study. 

. 2024;44(10):1704-1713. doi:10.1097/IAE.0000000000004174

2. Jeremias S. FDA approves biosimilar Enzeevu for eye conditions. The Center for Biosimilars

. August 12, 2024. Accessed February 4, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-biosimilar-enzeevu-for-eye-conditions

Enzeevu (aflibercept-abzv), a biosimilar developed by Sandoz, demonstrated biosimilarity to reference aflibercept (Eylea) in patients with neovascular age-related macular degeneration (nAMD).

Interchangeable Aflibercept Biosimilar, Enzeevu, Comparable With Eylea for nAMD

Josh Canavan, PharmD.

In an interview with Josh Canavan, PharmD, head of pharmacy at RazorMetrics, he discussed the role of pharmacy benefit managers (PBMs) in the biosimilar landscape. He emphasized the importance of PBMs in the development and approval process of biosimilars, and how they are responsible for ensuring that these medications are safe and effective.


Canavan also highlighted the importance of PBMs in educating patients and providers about biosimilars.

This transcript may be lightly edited for clarity. 

Do you have a preferred recommendation when you are suggestion education models for physicians and pharmacists?

The FDA has done a great job of providing education, and people typically trust that 

] also give specific links to clinical trials comparing biosimilars with biologics. There's a lot of data out there, so if you link directly to that clinical trial, specifically for a pharmacist or for a physician, they can see it in its original form basically, not something that we've created or something we've tailored. They can see the data. They can see all the endpoints that are there.

Multiple pieces of information help like the FDA website, clinical trials, and then we have our own section where we break it down a little bit simpler for patients or someone who's just not familiar with it quite yet.

What do you wish more people understood about the role PBMs play in the biosimilar space?

I think one of the things that maybe gets overlooked with PBMs is the amount of research they do before they put a medication onto their formulary. They typically have their own clinical teams, pharmacists, physicians, who are looking at all of these medications. They do research, they read the clinical trials like we've talked about, they look at comparative studies between biosimilars and biologics.

There's a lot of thought and detail that goes into it before it makes it on to their formulary. Once a PBM has added something to the formulary, they're very confident about its efficacy, its availability, how it's going to be received in the market.

I think that might be overlooked, the overall amount of time and effort that PBMs put into creating formularies, updating them, and making sure everything is correct for their members.

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, recommends key educational resources for biosimilars, and emphasizes the extensive research conducted before pharmacy benefit managers (PBMs) add medications, including biosimilars, to their formularies.

Understanding Biosimilars Through Education and PBM Formulary Perspective

Here are the top 5 biosimilar articles for the week of January 27, 2025. 

 in adolescent and young adult patients with inflammatory bowel disease (IBD) found no significant differences in lab markers or disease activity between those on Remicade and those switched to biosimilar CT-P13 (Inflectra).

, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).

 has been shown to be as safe and effective as its reference product for osteoporosis treatment, potentially enabling significant cost savings in Japan’s health care system while addressing persistent misconceptions about biosimilar quality.

: Sarfaraz K. Niazi, PhD, dives into the role that 

biosimilar associations and organizations

 play in promoting biosimilars as well as how their stakeholder demographic and main objectives differ from one another.

 across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

The Top 5 Biosimilar Articles for the Week of January 27

The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese regulatory agency approved a Stelara biosimilar.

The FDA accepted the biologics license applications (BLA) for AVT05, Alvotech’s and Teva Pharmaceuticals’ proposed biosimilar to golimumab (Simponi and Simponi Aria), which treats inflammatory conditions like rheumatoid arthritis.

This is the first BLA for golimumab biosimilar to be accepted by the FDA. The FDA expects to complete the review by the fourth quarter of 2025.


Alvotech and Teva partnered in 2020 to commercialize Alvotech’s biosimilars. The partnership has grown to 9 total products, including AVT05. 

Previously, 2 biosimilars developed through the partnership received FDA approval. Alvotech’s first approval for Simlandi, a biosimilar to Humira (adalimumab), came in February 2024.

 Humira biosimilar and launched in May 2024 as the first high-concentration, citrate-free interchangeable version and launched in May 2024.

Alvotech and Teva subsequently received FDA approval for Selarsdi, a Stelara (ustekinumab) biosimilar.

Selarsdi is expected to launch in the US by February 2025.

Samsung Biologics made history as the first biotech company in the Republic of Korea to make $2.78 billion in annual sales.

Overall, sales and profits increased by 23% and 19%, respectively. Samsung Bioepis, the biosimilar subsidiary of Samsung Biologics, reached ₩1.537 trillion ($1,064,765,744.52 USD) in sales and ₩435.4 billion ($301,646,861.60 USD) in profits.

Biosimilar products contributed to ₩517.4 billion ($358,456,789.60 USD) in sales increases across global markets and profits more than doubled to ₩230 billion ($159,344,920 USD) compared with the previous year. Samsung Biologics achieved its highest quarterly sales of ₩1.256 trillion ($870,161,824 USD) in the fourth quarter, representing a 17% increase year-over-year. Overall, operating profit decreased by 7% in the fourth quarter (₩325.7 billion or $225,646,262.80 USD).

Standalone operating profits declined 6% to ₩314.7 billion ($218,025,418.80 USD) due to investments in contract development and manufacturing enhancements. Stronger biosimilar sales boosted Samsung Bioepis’ fourth-quarter sales by 38% year-over-year (₩397.4 billion or $275,320,309.60 USD). However, high research and development costs decreased operating profit by 8% to ₩72.3 billion ($50,089,729.20 USD).

Samsung Biologics forecasts a 20% to 25% sales increase, projecting ₩5.57 trillion ($3,858,918,280 USD) in revenue. The company indicated it is in a stable financial position with its debt-to-income at 59% and a borrowing ratio of 12.3%. By the end of 2024, Samsung Biologics reported consolidated assets of ₩17.33 trillion ($12,006,293,320 USD), equity of ₩10.90 trillion ($7,551,563,600 USD), and liabilities of ₩6.43 trillion ($4,454,729,720 USD).

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan approved a subcutaneous ustekinumab biosimilar referencing Stelara.

Biocon Biologics, a leading global biosimilars company, developed and manufactured the ustekinumab biosimilar.

Biocon Biologics plans to commercialize and market the drug in Japan with its partner, Yoshindo Inc. The drug was designed and approved for patients with psoriasis vulgaris and psoriatic arthritis.

Biocon Biologics reached a licensing agreement with Janssen to commercialize ustekinumab in Japan following regulatory approval. 

Alvotech and Teva announce filing acceptance of US Biologics License Applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab). Press release. Alvotech. January 27, 2025. Accessed January 28, 2025. 

https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-teva-announce-filing-acceptance-us-biologics

Jeremias S. FDA approves 10th adalimumab biosimilar, Simlandi. The Center for Biosimilars

. February 24, 2024. Accessed January 30, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-tenth-adalimumab-biosimilar-simlandi

Jeremias S. Alvotech’s Stelara biosimilar, Selarsdi, receives FDA approval. The Center for Biosimilars. April 16, 2024. Accessed January 29, 2025. 

https://www.centerforbiosimilars.com/view/alvotech-s-stelara-biosimilar-selarsdi-receives-fda-approval

Hae-yeon K. Samsung Biologics hits W4.5tr sales milestone. The Korea Herald. January 22, 2025. Accessed January 28, 2025. 

https://www.koreaherald.com/article/10405085

Japan health authority approves Biocon Biologics’ ustekinumab BS, biosimilar to J&J’s Stelara. Indian Pharma Post. January 7, 2025. Accessed January 29, 2025. 

https://www.indianpharmapost.com/news/japan-health-authority-approves-biocon-biologics-ustekinumab-bs-biosimilar-to-jjs-stelara-16633

FDA Reviews Golimumab Biosimilar, Samsung Biologics Hits Record Sales, Japan Approves Stelara Biosimilar

Biosimilar SB17 demonstrated clinical biosimilarity to reference ustekinumab after switching and maintained long-term comparable efficacy and safety up to week 52. | Image Credit: Егор Кулинич - stock.adobe.com

Patients with psoriasis who switched from reference ustekinumab to its biosimilar, SB17, experienced comparable long-term efficacy and safety, alleviating concerns about switching and promoting wider use of more affordable treatment options, according to a study published in the 

Biologic treatments have improved efficacy and revolutionized the treatment landscape of psoriasis because they offer more affordable options to patients. The FDA reported generic and biosimilar medicines generated over $3 trillion in savings for patients and the health care system for the last 10 years.

Concerns surrounding switching from originators to biosimilars are often based on fears that patients would experience adverse outcomes like diminished efficacy or increased hypersensitivity.

 However, previous research found that the rates of serious adverse events, deaths, and treatment discontinuations among patients who switched between a biosimilar and a reference biologic were similar to those among patients who did not switch.

Additional clinical evidence has shown that switching from an originator product to a biosimilar version is safe and effective long-term and that itdoes not lead to undesirable clinical outcomes.

 for patients with plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease.

The phase 3, randomized double-blind, multicenter trial was conducted to assess the efficacy, safety, and immunogenicity of switching between SB17 and reference ustekinumab to determine if clinical biosimilarity remained up to week 52. There were 45 centers from 8 countries (Czech Republic, Estonia, Hungary, Republic of Korea, Lithuania, Latvia, Poland, and Ukraine) who participated during July 2021 to November 2022.

There were 503 participants as baseline who had a Psoriasis Area and Severity Index (PASI) greater than or equal to 12, a Physician’s Global Assessment of 3 or more, and a body surface area involvement of at least 10% at screening and randomization or more. At week 28, there were 481 participants who were rerandomized to either continue SB17 (SB17+SB17; n = 237), switch from ustekinumab to SB17 (UST+SB17; n = 122), or continue ustekinumab (UST+UST; n = 122).

Most of the participants (96.9%) completed the study up to week 52, with a balanced drop-out pattern (SB17+SB17, 1.7%; UST+SB17, 4.1%; UST+UST, 4.9%).

Across all treatment groups, the PASI from baseline up to week 52 was nearly identical, showing no signs of lack of efficacy. At week 52, the percent change of PASI was comparable between treatment groups (SB17+SB17, 95.8%; UST+SB17, 95.6%; UST+UST, 94.5%). The secondary efficacy endpoints from baseline to week 40 to week 52 were comparable across all 3 treatment groups.

Biosimilar SB17 and reference ustekinumab had similar safety profiles. The treatment emergent adverse events (TEAEs) were 16.5% for patients who continued SB17, 13.9% for patients who switched from ustekinumab to SB17, and 23.8% for patients who did not switch from the reference product. The most common TEAEs were COVID-19 and nasopharyngitis. There were no injection site reactions or systemic hypersensitivity found after switching between medications either.

The ongoing war in Ukraine posed a study limitation, disrupting some sites. However, these disruptions were evenly distributed across treatment groups, minimizing any potential bias.

These findings “may not prevent nocebo effects post-market, which may require additional efforts to mitigate” but“the lack of safety issues with ustekinumab switching to SB17 should be reassuring,” stated study authors.

Feldman SR, Narbutt J, Giampiero G, et al. Biosimilar SB17 versus reference ustekinumab in moderate to severe plaque psoriasis after switching: phase 3 study results up to week 52. J DermatolTreat. 2024;35(1). doi:10.1080/09546634.2024.2436607

2024 savings report. Association for Accessible Medicines. June 12, 2024. Accessed January 23, 2025. 

https://accessiblemeds.org/resources/blog/2024-savings-report/

Ferreri D. Analyzing safety of switching from originators to biosimilars: a meta-analysis of 21 trials. The Center for Biosimilars®. February 10, 2024. Accessed January 23, 2025. 

https://www.centerforbiosimilars.com/view/analyzing-safety-of-switching-from-originators-to-biosimilars-a-meta-analysis-of-21-trials

Biosimilar SB17 demonstrated clinical biosimilarity to reference ustekinumab after switching and maintained long-term comparable efficacy and safety up to week 52.

Switching From Ustekinumab to Biosimilar SB17 Maintains Efficacy, Safety in Patients With Psoriasis

Here are the top 5 biosimilar articles for the week of January 20, 2025. 

 (PBMs) increased many specialty generic drugs prices by hundreds of percent, with some drugs seeing thousands of percent markups, according to the Federal Trade Commission (FTC)’s second interim report on PBM practices.

: Achieving global regulatory harmonization for 

 is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.

 from Humira (reference adalimumab) to biosimilar adalimumab in Denmark led to no increase in total health care costs over 9 months, with significant cost reductions for those who switched to GP2017 specifically, highlighting the economic feasibility of biosimilar adoption.

: Biosimilar launches achieve a 53% market share and a 53% reduction in average drug costs after 5 years of biosimilar competition, according to 

Samsung Bioepis’ most recent market report

, showcasing notable pricing trends and market share disparities across therapeutic areas.

 has rapidly evolved since its launch in 2017, driven by steep price discounts, payer adoption, and provider confidence, with an upcoming wave of biosimilars targeting blockbuster biologics promising further market growth, cost savings, and broader patient access.

The Top 5 Biosimilar Articles for the Week of January 20

Here are the top 5 biosimilar articles for the week of January 13, 2025. 

: Korean drugmakers hold over 50% market share in the 6 best-selling 

, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

 demonstrated equivalent efficacy, safety, and immunogenicity compared with the originator in a phase 3 trial involving postmenopausal women with osteoporosis, paving the way for improved accessibility and cost savings in osteoporosis treatment.

 to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry.

: Sarfaraz K. Niazi argues that the Indian Central Drugs Standard Control Organisation 

(CDSCO) Biosimilar Guidelines need revision

 to align with current scientific understanding and focus on better manufacturing practices.

 showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.

The Top 5 Biosimilar Articles for the Week of January 13

A study from Spain found a subcutaneous tocilizumab biosimilar to be cost-effective when treating patients with RA after experiencing improved outcomes. | Image Credit: andranik123 - stock.adobe.com

Biosimilar tocilizumab (RoActemra; TCZ) improved outcomes of patients with rheumatoid arthritis (RA) living in Spain and saved health care costs compared with other treatments, suggesting a promising avenue for enhancing patient care and optimizing resource allocation, according to a study published in 

Patients diagnosed with RA experience high economic and humanistic burdens based on increased costs for the appropriate management of the disease and the associated morbidity. In Spain, about 5% of the total burden of rheumatic diseases are a result of RA. The prevalence of RA is increasing while mortality is decreasing, mainly in high-income countries where better management of disease control is practiced.

The development of biological disease modifying anti-rheumatic drugs (bDMARDs) altered the treatment paradigm 20 years ago, leading to improvements in disease control, less steroid consumption, and the attainment of a better overall quality of life. Disease effect and its progression are largely impacted by the bDMARDs. 

The European Commission approved TCZ for the treatment of moderate-to-severe RA in 2009 under Roche manufacturing.

 TCZ is noted as the first interleukin-6 receptor and inhibits monoclonal antibodies. The drug is indicated to be combined with methotrexate among patients with RA who responded inadequately or were intolerant to bDMARDs or tumor necrosis factor-α antagonists.

The current biosimilar therapeutic alternatives for RA management include abatacept, adalimumab, baricitinib, certolizumab, etanercept, golimumab, infliximab, rituximab, sarilumab, tofacitinib, upadacitinib, and TCZ.

The study aimed to develop a cost-effectiveness analysis of subcutaneous biosimilar TCZ for the treatment of RA compared with the most common alternatives in Spain through a health care lens.

The systemic literature review included 13 studies that demonstrated efficacy, meta-analyses, and a series of clinical trials for alternative treatments. The Disease Activity Score 28 (DAS28) had thresholds for each of the 4 health status categories: remission (DAS28 < 2.6); low disease activity (2.6 ≤ DAS28 ≤ 3.2); moderate disease activity (3.2 < DAS28 ≤ 5.1); and high disease activity (DAS28 > 5.1).

After 52 weeks of treatment, better performance was recognized after TCZ, upadacitinib, certolizumab, and filgotinib use. Patients with moderate-high disease activity status at 52 weeks were treated with rituximab, golimumab, and etanercept.

Higher levels of remission status were found among patients taking upadacitinib (12.67%), TCZ (12.61%), and sarilumab (12.58%). The quality-adjusted life years (QALYs) were 13.73 for both TCZ and sarilumab while upadacitinib obtained 13.74 values. Biosimilar TCZ had the lowest total cost per patient (€183,741), followed by infliximab (€184,317). Certolizumab displayed the highest cost per patient (€201,972) compared with biosimilar TCZ and infliximab.

The incremental cost-effectiveness ratio for patients in remission health status or QALY showed the biosimilar TCZ was either dominant or cost-effective compared with the alternative drugs. The most influential factors in variability of the results were the probability of transition from remission to low disease activity health status, long-term costs of biosimilar TCZ, and probability of transition from low to moderate disease activity health status.

Across all scenarios, biosimilar TCZ was the most cost-effective treatment option. There was a 100% chance biosimilar TCZ was cost-effective when compared with the other treatment options for both the €30,000 and the €22,000 thresholds that Spain uses often.

The ex-factory prices are used in this analysis because final reimbursed prices are not publicly available, which could have impacted the results. Biosimilars should be utilized earlier in the treatment setting to leverage all potential benefits. Reports in Spain have found increased biosimilar adoption would allow additional patients to be treated by redirection of savings, improved health care resource allocation, and better patient care.

Pérez-Ruiz F, Crespo-Diz C, Schoenenberger-Arnaiz JA, et al. Cost-effectiveness analysis of subcutaneous biosimilar tocilizumab in patients with rheumatoid arthritis in Spain. 

. Published online December 1, 2024. doi:10.1016/j.farma.2024.11.004

Nataloni R. Tocilizumab approved for rheumatoid arthritis in Europe. Medscape. January 23, 2009. Accessed January 14, 2025. 

https://www.medscape.com/viewarticle/587253

A study from Spain found a subcutaneous tocilizumab biosimilar to be cost-effective when treating patients with rheumatoid arthritis (RA) after experiencing improved outcomes.