Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

The Top 5 Biosimilar Articles for the Week of March 17

Global biosimilar regulatory harmonization

 will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

 matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting.

 market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

 are joining the fray, expanding access to lower-cost alternatives to blockbuster originator biologic, Janssen’s Stelara.

: Sarfaraz Niazi, PhD, urges the FDA to let the 

 create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility.

To read all of these articles and more, visit 

Videos

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

Patients with moderate to severe plaque psoriasis who switched between the adalimumab biosimilar GP2017 and reference adalimumab did not impact immunogenicity, safety, or efficacy following up to 4 switches between both drugs. | Image Credit: pimentos - stock.adobe.com

The adalimumab biosimilar GP2017 and reference adalimumab used to treat patients with moderate to severe plaque psoriasis did not significantly impact immunogenicity, safety, or efficacy, even after multiple switches, suggesting potential cost savings and improved access to biosimilars, according to a study published in 

A standard approval process confirms that biosimilars have the same efficacy, safety, and immunogenicity profile as the reference biologic. In the US, interchangeability is a legal distinction that established the biosimilar pathway, but it is not well understood. Health care professionals and other stakeholders often hold misconceptions that believe interchangeable biosimilars are better than biosimilars without interchangeability designation. However, there is an ongoing discussion between clinicians about the necessity of an interchangeability designation in the US, with many believing the additional demand of efficacy and safety data goes beyond the required evidence for approval.

Last year, the FDA submitted draft guidance that argued biosimilars should receive interchangeability status without extensive switching studies, which would essentially remove interchangeability while maintaining status and complications.

 The Biologics Price Competition and Innovation Act may remove interchangeability in 2025, leaving an allowance for carrying over exclusivity to products with this status, speculated Sarfaraz K. Niazi, PhD.

Researchers designed the ADACCESS trial (NCT02016105) to assess biosimilarity between the biosimilar adalimumab-adaz (Sandoz; GP2017) and reference adalimumab (AbbVie; Humira) in patients with moderate to severe chronic plaque psoriasis.

 The ADACCESS study was a 51-week multicenter, randomized, double-blind controlled confirmatory efficacy and safety study. Researchers continuously treated patients with reference adalimumab (cH group) and had patients who experienced 4 switches between the reference drug and GP2017 (H2H group).

Using electrochemiluminescence (ECL) antidrug antibody (ADA) assays, the ADA signal-to-noise (S/N) ratio, a continuous variable, has been proposed as an alternative approach for assessing the magnitude of ADA response. Researchers define ADA S/N as the ratio of the ECL signal of the sample divided by the negative control signal. The study authors investigated potential differences in immunogenicity based on ADA S/N ratio as an alternative end point.

There were 63 participants in the cH group and 127 participants in the H2H group who were considered for the ADA analysis. At week 17, the cH group had 58 participants, and the H2H group had 122 participants. By week 41, or 6 weeks after the fourth switch, there were 46 participants in the cH group and 100 participants in the H2H group. Both week 17 and week 41 were all within the defined margin of –0.16 to 0.16. The 90% CIs remained within the margin for all other time points.

The efficacy was comparable between the cH arm and H2H switching arm, showing that switching does not impact efficacy. Adverse events (AEs) and serious AEs were comparable and similar in terms of System Organ Class and Preferred Term levels. There were no patterns or imbalances between treatment groups regarding AEs with a suspected causal relationship to the study medication, or other safety information relevant to the benefit-risk assessment.

The ADA S/N ratio limits the study because it is more sensitive to showing differences in immunogenicity than a pharmacokinetic end point following single-dose administration of GP2017 in healthy patients. The hypothesis neglects data-driven confirmation, and the study does not have a positive control. Clinical studies and real-world settings have not observed increased immunogenicity upon reference product to biosimilar switching or upon repeated biosimilar switches.

“This could lead to decreased costs for development of biosimilars, which may result in savings for healthcare systems and improved access for patients to these drugs,” study authors concluded.

LemkeL, BlauveltA, BrückmannI, et al. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. 

. 24(12);1375-1385. doi:10.1080/14712598.2024.2428299

Humphreys S. Understanding interchangeable biosimilars at the federal and state levels. 

. 2023;29(7):545-548. doi:10.37765/ajmc.2023.89419

Jeremias S. FDA draft guidance removes switching study requirements for biosimilar interchangeability. The Center for Biosimilars®. June 20, 2024. Accessed March 20, 2025. 

https://www.centerforbiosimilars.com/view/fda-draft-guidance-removes-switching-study-requirements-for-biosimilar-interchangeability

Niazi SK. BioRationality– the evolution of the BPCIA and the bright future of biosimilars in the US. The Center for Biosimilars®. October 7, 2024. Accessed March 19, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-the-evolution-of-the-bpcia-and-the-bright-future-of-biosimilars-in-the-us

Articles

Patients with moderate to severe plaque psoriasis who switched between the adalimumab biosimilar GP2017 and reference adalimumab did not impact immunogenicity, safety, or efficacy following up to 4 switches between both drugs.

Multiple Switches Between Adalimumab Biosimilar GP2017 and Humira for Psoriasis Maintain Biosimilarity

The Top 5 Biosimilar Articles for the Week of March 10

: A prospective cohort study found that switching back from the 

 to the reference infliximab did not affect clinical disease activity or safety in inflammatory bowel disease (IBD).

 of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.

: Sarfaraz Niazi, PhD, urges the FDA to let the USPharmacopeia (USP) 

 for biosimilars to cut costs, speed development, and enhance accessibility.

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

: Celltrion's Omlyclo (omalizumab-igec) is the 

 to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

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

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

: 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.

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

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.