Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

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

 (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

: February brought policy updates and several biosimilar approvals, including the first FDA approval for an 

 (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

: Patients with inflammatory bowel disease (IBD) who 

 (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable with those who remained on the originator drug, according to a Canadian study.

 enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable drugs in the world.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of March 3

The top 5 biosimilar articles for the week of February 24, 2025.

: Celltrion expands its reach in Europe, 

 from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

 as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

: Sarfaraz K. Niazi, PhD, gives his opinion on how the recent 

 “Assessing the Biosimilar Void in the US” could be improved for the future.

: The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to 

, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

Here are the top 5 biosimilar articles for the week of February 24, 2025.

The Top 5 Biosimilar Articles for the Week of February 24

Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin. | Image Credit: Ekaterina - stock.adobe.com

Bevacizumab biosimilars show equivalent therapeutic efficacy and similar safety profiles to the originator products when managing locally advanced or metastatic non-small cell lung cancer (

The FDA has approved 5 bevacizumab biosimilars that reference Avastin (bevacizumab). Amgen’s Mvasi (bevacizumab-awwb) received approval in September 2017, followed by the approval of Zirabev (bevacizumab-bvzr; Pfizer) in June 2019.

In 2022, both Alymsys (bevacizumab-maly; Amneal Pharmaceuticals) and Vegzelma (bevacizumab-adcd; Celltrion Healthcare) were FDA approved. Avzivi (bevacizumab-tnjn; Bio-Thera Solutions) was the most recent bevacizumab biosimilar to receive FDA approval in December 2023.

As lung cancer remains the leading cause of cancer-related death across the globe, innovative therapies are being utilized to target and address disease progression.

 Combination therapies are gaining popularity, which could lead to biosimilars helping reduce health care spending without compromising therapeutic effectiveness. When a reference drug’s primary patents expire, biosimilars can foster market competition, reduce costs, and enhance patient access to vital biologic therapies.

The study authors compared the safety and effectiveness of bevacizumab biosimilars with the reference drug in combination with chemotherapy for NSCLC. They did this to examine the context of rising health care costs, enhance affordability, and broaden patient access to life-saving treatments.

Researchers conducted a retrospective analysis between January 2021 and December 2023 that enrolled 1058 patients who received 1 of the 5 versions of a bevacizumab biosimilar dosed at 15 mg/kg intravenously every 21 days (originator, n = 452; biosimilar, n = 606). The median age of the participants was 60.5 years, with 56.52% male and 43.48% female. The gender distribution in the groups did not have significant differences either.

None of the patients achieved a complete response (CR). The biosimilar group had an overall response rate (ORR) of 27.41% (95% CI, 24.1%-31%), with 180 patients who experienced partial response (PR) and 361 patients who experienced stable disease out of 606 patients.

The reference group had an ORR of 29.79% (95% CI, 26.5%-32%) and a disease-free rate of 87.3%. In the initial treatment group, 142 patients developed PR, and 250 patients developed stable disease. Study results showed consistency with the FDA, European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency in Japan.

Researchers split patients into 2 groups based on survival status (deceased or surviving). Smoking history, performance status, stage at diagnosis, and comorbidities showed significant associations with survival status (

 < .05). The study found no significant associations between survival status and age, sex, or treatment regimen (biosimilar vs reference drug).

The biosimilars significantly increased the risk of hypertension in patients older than 70 years of age who were treated with a high dose of the drug compared with the reference product (

 < .05). Both groups did not have significant differences in the incidence of hypertension after the exclusion of patients with a history of hypertension and those who had been treated with a very high dose.

Adverse events (AEs) were experienced in 76.42% of patients with a total of 2306 instances observed in which 3 or more grade 3 AEs occurred. The biosimilar-treated groups and originator groups had similar frequencies of transient AEs, most of them being grade 1 or 2. The study found no statistically significant differences in the occurrence of grade 3 and 4 transient AEs between the 2 groups.

In the biosimilar group, the most common treatment-emergent adverse events (TEAEs) were fever (8.71%) and anemia (9.15%). The initial drug group had the highest prevalence of anemia at 15.33%. Patients experienced fatigue, pneumonia, leukopenia, neutropenia, thrombocytopenia, hypertension, bleeding, and thromboembolism as other TEAEs.

The retrospective design of the study introduces potential biases and confounding factors, which complicate balancing patient characteristics and treatment histories between the bevacizumab and biosimilar groups, the authors acknowledged. The various treatment protocols and dosages further clouded the isolation of individual drug effects. The absence of randomization potentially skewed outcomes and compromised the researchers' ability to compare the drugs.

Additionally, the brief follow-up periods limit the insights into long-term survival benefits. Researchers have not yet fully elucidated the study mechanisms, and other targeted treatments remain unexplored. The reported AEs lacked depth on the long-term impacts and quality of life considerations. The limited data on rare genetic mutation subgroups hinders robust conclusions on safety and efficacy, according to the study.

Addressing the study's limitations is crucial for advancing precision medicine and promoting equitable health care, as it can ensure the generalizability of treatment outcomes across diverse patient populations.

“Future research is essential to refine safety assessments, optimize patient benefit, minimize risks, and support evidence-based adoption of biosimilars in oncology,” study authors stated.

Zhang X, Chu X, Wang J, et al. Retrospective analysis of survival and safety of bevacizumab biosimilar and original drug combination chemotherapy in non-small cell lung cancer. 

Biosimilar approvals. The Center for Biosimilars

. Updated February 24, 2025. Accessed February 25, 2025. 

https://www.centerforbiosimilars.com/biosimilar-approvals

Articles

Patients with non-small cell lung cancer (NSCLC) taking bevacizumab biosimilars demonstrated equivalent therapeutic efficacy and similar safety profiles to those taking the originator product, Avastin.

Bevacizumab Biosimilars Show Similar Efficacy, Safety in NSCLC

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products. | Image Credit: thien - stock.adobe.com

Innovative statistical methods, such as simultaneous CIs and multiplicity-adjusted TOST (MATOST) were explored by researchers to address challenges posed by differing FDA and European Medicines Agency (EMA) regulatory requirements for biosimilar approvals, according to a review published in 

These differences have prompted research into innovative statistical methods for more efficient and accurate biosimilar assessments. When a biosimilar has both US and EU reference products, sponsors must conduct 3 bridging studies comparing the biosimilar product with the US-licensed reference product, the biosimilar product to the EU-approved reference product, and the US-licensed reference product to the EU-approved one.

Despite Europe's greater biosimilar adoption, regulatory disparities and complex US approval processes hinder development, underscoring the need for global harmonization.

The FDA and EMA also differ on foreign-approved comparators; the EMA permits them (with caveats), while the FDA requires 3-way comparisons.

Researchers criticize the conventional 3-way comparison for neglecting variability, underutilizing data, and creating multiple testing issues. This study investigated 2 alternatives, simultaneous confidence intervals and MATOST.

Regulatory Framework for Biosimilar Approval

Both agencies have slightly different definitions for biosimilars. The FDA defines biosimilars as biological products highly similar to the reference product, with no clinically meaningful differences between safety, purity, and potency compared with the reference product. However, the EMA defines biosimilars as biological medicinal products containing the same active substance as the reference product and similar in quality characteristics, biological activity, safety, and efficacy.

The FDA's stepwise approach assesses analytical similarity, investigating the structural and functional characteristics of the biosimilar product based on critical quality attributes at various stages of the manufacturing process. The stepwise approach includes a pharmacokinetics (PK) and pharmacodynamics (PD) similarity assessment, demonstrating PK and PD through human clinical pharmacology studies after passing animal toxicity studies, and a clinical similarity assessment, gathering information on immunogenicity, clinical efficacy, and safety.

Additionally, the main purpose of the 3-way comparison is to ensure the drug substance or product meets product specifications, to demonstrate biosimilarity between the test product and the US-licensed product, and to establish a bridge justifying the use of clinical data generated using the EU-approved reference product as the comparator. Strict requirements on biosimilar products are necessary to ensure the efficacy and safety of biosimilars on the market.

The drug sponsor should provide 3-way bridging evidence when using a non–US-licensed product in a regulatory submission for a biosimilar product. This evidence justifies the use of comparative data from the non–US-licensed product in assessing biosimilarity and bridging to the US-licensed reference product.

Disadvantages, such as underutilizing data collected from the entire study, can impair conventional pairwise comparisons, potentially biasing and misleading results. Since pairwise comparisons do not use the same reference product in each comparison, and each comparison may use a different equivalence acceptance criterion margin, the precision of each equivalence test varies. Multiple comparisons will inflate the type 1 error rate unless some significance-level adjustment approaches are considered. Overall, these pairwise comparisons cannot distinguish the relationship among the biosimilar product, the US-licensed reference, and the EU-approved reference.

Without loss of generality, the US-licensed reference product and the EU-approved reference product are considered as the 2 reference products, with the US-licensed reference as the primary reference.

Comparative Analysis of Statistical Approaches

The simultaneous CI method in a parallel study design used fiducial probabilities to perform pairwise equivalence tests. The simulation study used 4 methods for pairwise comparison and included 3 simultaneous CI methods with different assumptions and 1 conventional approach. The results found all approaches can maintain desired power when the sample size per arm is larger than 20. The simultaneous CI method under equal variability has the best performance among all the methods and can achieve similar statistical power to the conventional approach. The study found that the simultaneous CI method works well in parallel study design.

Among simulation results, the Holm and Bonferroni method were very conservative, and TOST was more likely to fail to reject the null hypothesis to control type 1 error inflation. In a crossover design with multiple formulations, especially within the Williams design, the MATOST method is not favorable since it may lead to an unrealistically large sample size, though it can control the type 1 error rate.

Addressing Challenges in Equivalence Testing

The FDA requires sponsors submitting biosimilar products for regulatory approval to conduct a 3-way pairwise comparison when both US-licensed and EU-approved reference products exist. Determining equivalence margins in the equivalence tests is crucial. Using sample estimation in the hypothesis setting is unnecessary because it does not consider the variability of the estimation.

Generalizing the CI method will allow researchers to determine equivalence margins by sampling standard deviations and considering the variability of the estimation. Researchers need to propose another method for controlling type 1 error inflation specifically for crossover designs to reduce the large sample size required for conducting a biosimilar study.

“For future research, it is possible to consider further utilization of fiducial inference under crossover designs and generalize the simultaneous CI method...,” the authors concluded. “Generalizing the simultaneous CI method can help researchers in determining equivalence margins by sampling standard deviations and taking the variability of estimation into consideration.”

Pong A, Chow S, Chow SC. Comparison of innovative and conventional methods in biosimilar bridging studies with multiple references. 

. 2024;18:377-387. doi:10.2147/btt.s470182

Jeremias S. Improving biosimilar access through global regulatory convergence. The Center for Biosimilars

. January 15, 2025. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/improving-biosimilar-access-through-global-regulatory-convergence

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements

The top 5 biosimilar articles for the week of February 17, 2025.

 (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.

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

 a pivotal year for biosimilars with Amgen's Wezlana leading ustekinumab biosimilar launches, potentially driving savings and access, as highlighted by Dracey Poore, MS, of Cardinal Health.

 saved $67 million in 2023 through its strong adoption of biosimilars to curb the high costs of biologic therapies to treat chronic disease.

Here are the top 5 biosimilar articles for the week of February 17, 2025.

The Top 5 Biosimilar Articles for the Week of February 17

Researchers treated postmenopausal women with osteoporosis with teriparatide biosimilar RGB-10, which improved their bone health measures and reduced fracture risk comparably to reference teriparatide. | Image Credit: mat - stock.adobe.com

Teriparatide biosimilar RGB-10 and reference teriparatide showed consistent therapeutic effects in postmenopausal women with osteoporosis at very high risk of fracture, with no significant differences observed between the 2 treatments across various bone health measures or at any assessment time point, according to a study published in 

Current therapeutic strategies for postmenopausal women managing osteoporosis aim to decrease fracture risk by using either antiresorptive or anabolic agents. The development of the osteoanabolic therapies teriparatide, abaloparatide, and romosozumab has recently expanded the treatment landscape.

Eli Lilly originally gained US approval for teriparatide (Forteo) in 2002 and European approval in 2003, based on results from a phase 3 study. The originator teriparatide patent expired in 2019, which spurred the development of several biosimilar compounds that have since received marketing authorization.

In January 2017, the European Medicines Agency approved the first teriparatide biosimilar products, Terrosa (Gedeon Richter) and Movymia (Stada Arzneimittel).

Theramex received approval for Livogiva in 2020, followed by Accord Healthcare for Sondelbay in 2022, and Strides Pharma Limited for Kauliv in 2023. Preclinical studies confirmed the biologics' structure, purity, and biological activity, and a randomized, double-blind pharmacokinetic/pharmacodynamic study provided further support for these approvals.

The current retrospective study analyzed the real-world comparative efficacy of RGB-10, a teriparatide biosimilar, and reference teriparatide in reducing osteoporosis measures among postmenopausal women with very high fracture risk. Researchers used multiple assessment methods, including dual-energy x-ray absorptiometry (DXA) and 3D-SHAPER imaging, to evaluate bone microarchitecture and fracture risk by determining bone mineral density (BMD). They also performed trabecular bone score (TBS) assessments, quantitative ultrasound (QUS), and high-resolution peripheral quantitative CT (HRpQCT) imaging of the radius and tibia.

Researchers administered both RGB-10 (n = 25) and reference teriparatide (n = 25) once a day in 20 μg subcutaneous doses for over 2 years among postmenopausal women with very high fracture risk. They found no significant differences between groups in terms of mean (SD) age (reference teriparatide, 68.4 [7.3] years; RGB-10, 68.5 [6.7] years), weight (reference teriparatide, 61.3 [10.1] kg; RGB-10, 61.2 [11] kg), or body mass index (reference teriparatide, 22.6 [2.9]; RGB-10, 22.3 [3.2]).

The study showed no significant differences between reference teriparatide and RGB-10 regarding family history of osteoporosis, tobacco use, glucocorticoid use, the incidence of diabetes mellitus and rheumatoid arthritis, prior bisphosphonate use, or the prevalence of fractures. Researchers also found no significant differences among the treatment groups at baseline for any measurement parameters assessed by DXA, 3D-SHAPER, TBS, QUS, and HRpQCT.

At 12 and 24 months of treatment, both reference teriparatide and biosimilar RGB-10 showed significant improvements from baseline in mean BMD at the lumbar spine, as measured by DXA. Researchers found no significant statistical difference between the treatment groups at any site or time point.

Both treatment groups experienced significant increases in trabecular volumetric BMD at both 12 and 24 months, with no significant differences between the groups. This technique showed no significant changes from baseline in other measured parameters for either treatment group.

RGB-10 treatment significantly increased integral volumetric BMD from baseline at both 12 and 24 months. Reference teriparatide treatment showed no statistically significant changes in integral volumetric BMD from baseline, and there were no significant intergroup differences.

Neither treatment group experienced significant changes in median TBS from baseline at 24 months. However, at 12 months, the RGB-10 group showed transient but significant improvement in TBS from baseline, without any statistically significant intergroup differences.

The RGB-10 group showed a significant increase in median QUS from baseline at 24 months, but the study found no significant differences between treatment groups in median QUS scores at either 12 or 24 months. Similarly, although some significant changes from baseline occurred at the radius and tibia at 12 and 24 months within both groups, the study observed no statistically significant intergroup differences related to treatment.

The study also found no statistically significant differences between the teriparatide biosimilar and reference teriparatide groups for any measured parameter at any timepoint. No incident fractures occurred during the treatment period.

Although the retrospective nature of this study introduced the possibility of selection bias and limited the ability to draw definitive conclusions, the observed consistency between RGB-10 and reference teriparatide across a range of bone health parameters is noteworthy.

“Real-world evidence of the clinical benefit of the RGB-10 biosimilar in high fracture risk osteoporosis patients provides clinicians and patients with a valuable therapeutic option in this vulnerable patient group,” the study authors concluded. 

Hadji P, KamaliL, ThomasiusF, Horas K, Kurth A, Bock N. Real-world efficacy of a teriparatide biosimilar (RGB-10) compared with reference teriparatide on bone mineral density, trabecular bone score, and bone parameters assessed using quantitative ultrasound, 3D-SHAPER and high-resolution peripheral computer tomography in postmenopausal women with osteoporosis and very high fracture risk. 

. 2024;35:2107-2116. doi:10.1007/s00198-024-07208-z

Biosimilar Approvals. The Center for Biosimilars®. January 7, 2025. Accessed February 14, 2025. 

Researchers treated postmenopausal women with osteoporosis with teriparatide biosimilar RGB-10, which improved their bone health measures and reduced fracture risk comparably to reference teriparatide.

Teriparatide Biosimilar Shows Comparable Efficacy to Reference Drug in Postmenopausal Osteoporosis

Here are the top 5 biosimilar articles for the week of February 10, 2025.

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

 and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.

Committee for Medicinal Products for Human Use

 (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.

: Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant 

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

: Of the 118 biologics losing exclusivity over the next decade, only 

, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.

The Top 5 Biosimilar Articles for the Week of February 10

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. 

https://naspa.us/event/national-pharmacist-day-2/

Littrell A. How different sectors of the health care industry can overcome challenges in 2025. 

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https://www.medicaleconomics.com/view/how-different-sectors-of-the-health-care-industry-can-overcome-challenges-in-2025

Mikulic M. Prescription drug expenditure in the US from 1960 to 2024. Statista. December 12, 2024. Accessed January 3, 2025. 

https://www.statista.com/statistics/184914/prescription-drug-expenditures-in-the-us-since-1960/

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

https://www.biospace.com/u-s-pharmaceutical-market-size-to-reach-usd-1-093-79-billion-by-2033

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

https://www.bf-law.com/blog/patient-protection-affordable-care-act-affects-pharmacies/

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. 

https://natlawreview.com/article/post-election-outlook-issues-watch-pharmacy-industry-stakeholders

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. 

https://www.fiercehealthcare.com/payers/2025-outlook-alternative-pbms-look-heap-pressure-industry-titans

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/

Landi H. Mark Cuban wants to keep shaking up healthcare. Fierce Healthcare. August 15, 2024. Accessed January 3, 2025. 

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

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.

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).