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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Articles

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.

A Banner Year for Biosimilars: The 19 FDA Approvals From 2024

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.

BioRationality: Biosimilar Associations and Stakeholders Representing Biosimilars

The 3 largest pharmacy benefit managers (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.

FTC Releases Second Report on PBMs Meddling in Generic Drug Markets

Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the biosimliar's FDA approval.

Functional Similarity Between Ustekinumab Biosimilar ABP 654, Stelara in Crohn Disease

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Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.

Federal Perspective on the Biosimilar Influence on Drug Costs

During a panel on the second day of the 2017 AAM Biosimilars Council Conference, held in Washington DC, regulatory leaders from Pfizer and Sandoz shared their experiences with the development of their biosimilar products: epoetin alfa (Epogen) and etanercept (Erelzi), respectively.

Industry Regulatory Experts Share Learnings From the Biosimilar Approval Process

The approval for adalimumab-adbm comes a year after the first adalimumab biosimilar, by Amgen, was approved in September of 2016.

Competition Strengthens for Humira Market With Approval of Second Biosimilar

Janssen Moves to Block Marketing of Renflexis in Suit Against Samsung Bioepis

Senate Confirms Scott Gottlieb as FDA Commissioner

Amgen Gains EC Approval for Biosimilar to Adalimumab 

Mylan's Settlement With Genentech and Roche Opens US Market for Trastuzumab Biosimilar

New Mexico Senate Passes Bill for Biosimilar Substitution 

How Will the Genentech-Amgen Feud Bear Down on Biosimilar Development?

 Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.

 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in 

. This approval is also notable in that there are currently no denosumab biosimilars approved in the European Union. The news comes after the same products were approved in Canada 

Similar to the reference products, the biosimilars have the same drug compound (denosumab-bddz) but were approved with 2 brand names that will be used for different indications:

Wyost vs Jubbonti

Jubbonti is interchangeable with Prolia, and Wyost is interchangeable with Xgeva.

Wyost and Jubbonti were also approved with interchangeability designations, allowing them to be substituted for their respective reference product at the pharmacy level without needing to wait for a provider to give permission. It is the ninth biosimilar to receive this label.

"Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most," commented Keren Haruvi, President Sandoz North America, in a statement.

According to Sandoz, over 10 million adults over age 50 in the US have osteoporosis, of whom most (> 80%) are women. It is predicted that 1 in 2 women and 1 in 4 men will experience an osteoporosis-related fracture in their lifetime, which could result in decreased quality of life, disability, and death.

The approval of Wyost/Jubbonti was based on a comprehensive data package containing 

 results that were presented at the American Society of Clinical Oncology annual meeting 2023 and the American Society for Bone and Mineral Research annual meeting 2023, respectively.

Denosumab products are human monoclonal antibodies that bind to the RANKL protein, preventing activation of the RANK receptor on the surface of osteoclasts and preventing osteoclastic bone resorption.

The phase 1 study evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab-bddz compared with the reference product (EU authorized and US licensed) in 499 healthy participants (mean [SD] age, 64.6 [6.1] years; White, 90.9%).

 The double-blind, 3-arm, parallel-group analysis was conducted at 2 German centers. Participants were randomized 1:1:1 to receive the biosimilar or the EU- or US-sourced reference agents.

Participants were between 28 and 65 years old and weighed between 50 and 90 kg. PK end points were measured by area under the serum concentration-time curve measured from the time of dosing and extrapolated to infinity (AUC

), or to the last measurable concentration (AUC

), and maximum observed serum concentration (C

). PD end points were measured by the area under the effect-time curve of the percentage change from baseline (AUEC %CfB) in serum carboxy-terminal crosslinked telopeptide of type I collagen (CTX) and CTX and procollagen I N-terminal propeptide (PINP) serum concentration per visit.

Results showed that the treatment arms (biosimilar vs EU-sourced reference product; biosimilar vs US-sourced reference product) showed statistically similar values for AUC

 (1.02; 1.00), and AUEC %CfB in CTX (1.01; 1.01). Changes from baseline to Week 39 in serum concentrations of CTX and PINP were also similar between groups.

The international, double-blind, parallel group phase 3 trial (ROSALIA study; 

) looked at the clinical efficacy, safety, and tolerability of denosumab-bddz compared with the reference product through 52 and 78 weeks.

 Postmenopausal women with osteoporosis aged 55 to 80 years who had bone mineral density (BMD) T-scores between 2.5 and 4.0 at the lumbar spine were eligible for participation.

In total, 527 patients were randomized 1:1 to receive a 60-mg dose of Wyost or the EU-authorized reference product on day 1 and at week 26. Prior to the third dose at week 52, patients who were receiving the reference product were rerandomized to remain on the reference product or switch to the biosimilar.

Overall, 502 patients received a third dose (biosimilar to biosimilar, n = 253; reference to reference, n = 125; reference to biosimilar, n = 124). The mean age of the participants was 64.6 (6.15) years, and most (91.3%) were White.

No clinically meaningful differences between the groups regarding new vertebral fractures were observed. Switching from the reference product to the biosimilar did not affect the incidence or severity of treatment-emergent adverse events (TEAEs). Immunogenicity profiles were similar between groups.

Most TEAEs were grade 1 or 2, most of which were not considered treatment related, and no treatment discontinuations occurred as a result. The most common TEAEs reported were hypocalcemia, COVID-19 infection, and nasopharyngitis.

The majority of antidrug antibodies had very low, nonreportable titers (< 20 mg/mL), were nonneutralizing, and transient.

In its company statement, Sandoz declined to comment on a launch timeline due to ongoing litigation issues with the reference product manufacturer (Amgen).

I think they are excited for these biosimilars to come to market and are ready to prescribe them to patients.

I think they will wait for more real-world data with these products before prescribing them.

I think they will need more education on the safety and efficacy on these products before feeling comfortable prescribing them.

Sandoz receives FDA approval for first and only denosumab biosimilars. News release. Sandoz; March 5, 2024. Accessed March 5, 2024. 

https://www.marketscreener.com/quote/stock/SANDOZ-GROUP-AG-160016887/news/Sandoz-receives-FDA-approval-for-first-and-only-denosumab-biosimilars-46097288/

2. Vogg B, Poetzl J, El Galta R, Fuhr R, Schwebig A, Sekhar S. Pharmacokinetics and pharmacodynamics of proposed denosumab biosimilar and reference denosumab in healthy male subjects. Presented at: 2023 ASCO Annual Meeting; June 2-6, 2023; Chicago, IL. Poster SAT-436.

3. Jeka S, Dokoupilová E, Kivitz A, et al. Pharmacokinetics and pharmacodynamics of proposed denosumab biosimilar and reference denosumab in postmenopausal osteoporosis: the ROSALIA study. Presented at: ASBMR 2023 Annual Meeting; October 13-16, 2023; Vancouver, Canada. Poster P303.

Sandoz’ Wyost/Jubbonti (denosumab-bddz) references Prolia and Xgeva and can be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

Clinical

Business & Practice

Approvals Launches

FDA Approves First Denosumab Biosimilars

Sarah Hudson-DiSalle, PharmD, RPh, FACCC

In an interview, Sarah Hudson-DiSalle, PharmD, RPh, FACCC, pharmacy manager at The Ohio State University Comprehensive Cancer Center – The James and The Ohio State University Wexler Cancer Center, highlighted how automating biosimilar selection through electronic health records (EHRs) significantly improves patient access to affordable treatments. 

She noted that biosimilars reduce patient out-of-pocket costs and streamline processes for health care teams. During a pilot program, automation in favor of biosimilars reduced the average time to treatment approval from 12 days to 4 days, enhancing efficiency for pharmacists, providers, and authorization teams. However, she also emphasized the challenges of payer alignment, insurance accuracy, and timely updates, which can impact the effectiveness of automated systems.

How could automating biosimilar selection through the EHR improve patient access to more affordable treatments?

So, we know with biosimilars the first thing is decreased costs. And with that, we have seen patients have decreased out-of-pocket expenses. There's also assistance that helps these folks pay their coinsurances or their co-pays. But really having that percentage, and many of the plans have a percentage out-of-pocket [costs]. The use of a biosimilar with the decreased cost has just less expenses for our patients.

So as I said before, we saw a decrease in our initial pilot from 12 days to 4 days. When your staff kind of comes to you in the middle of the pilot and says, "When can we turn this on for the other agents?" It was an overwhelming response from our team that said, "This really is more efficient for us. We had less time that our specially practiced pharmacists were making changes for interchangeability, less time for our providers. And then, also, we were getting patients into the chair much quicker."

So the authorization team really found a lot of benefit in having that information that comes to them. And you can also see that if the insurance in the [EHR] is not entered in correctly. Let's say the patient's secondary [insurance] is entered in as the primary insurance so the wrong biosimilar is picked, I hear about it. So, I hear about the things that maybe don't go right but when your team says, "Hey, I want this to work properly," I think it speaks volumes.


And one of the barriers that does occur is depending on how many payers that the system might have, or the practice might have—The James has a large payer mix, and so initially we have 25 payers that we used in this model—if you don't have alignment, or your advanced order group is not aligned with the payer's biosimilar, it can then have some downstream implications that occur with that. Or if the patient's insurance isn't updated appropriately in that time, you could have the tool picking the wrong insurance's biosimilar. That's probably where we have seen the advanced order group fail. And then updates sometimes too. It just takes a little bit of time to make sure that those updates [are done]. Those are human steps that we have to incorporate. I wish we could say, if we know when the biosimilar has changed, that would be an immediate evaluation from our finance team. It just takes a little time.

Streamlining Biosimilar Access: How EHR Automation Transforms Patient Care

Biosimilar CT-P42 (Celltrion) demonstrated therapeutic equivalence to reference aflibercept (Eylea; Regeneron) in improving best-corrected visual acuity (BCVA) in adults with diabetic macular edema (DME), showing comparable efficacy, safety, pharmacokinetics (PKs), and immunogenicity profiles, according to a phase 3 clinical trial.

The randomized, active-controlled, double-masked study, 

 evaluated the efficacy and equivalence of the biosimilar CT-P42 to aflibercept, with promising interim results at 24 weeks and further data expected at 52 weeks.

DME, a major cause of vision loss in diabetes, results from retinal vascular damage and vascular endothelial growth factor (VEGF) overexpression, which aflibercept (Eylea) addresses as a high-affinity VEGF inhibitor approved for DME treatment. CT-P42 has received approval from the Ministry of Food and Drug Safety in South Korea and is currently under review by the European Medicines Agency and the FDA.

Currently, there are 5 aflibercept biosimilars approved in the US, all of which are awaiting the results of legal disputes to determine when they will be able to enter the market.

According to Regeneron, DME affects approximately 750,000 Americans with diabetes.

 The disease can develop at any stage of diabetic retinopathy, with symptoms such as blurred vision and floaters, and is diagnosed through comprehensive eye exams and imaging tests, while risk factors include longer diabetes duration, severe diabetic retinopathy, and poor blood sugar control.

The study was conducted across 83 centers in 13 countries. It included 3 periods: screening, a main study period (52 weeks), and an open-label extension (4 weeks). A total of 348 patients with DME were randomized (1:1) to receive either CT-P42 or reference aflibercept via intravitreal (IVT) injections (CT-P42, n = 173; reference aflibercept, n = 175), with 335 (96.3%) completing the study through week 24. The dosing regimen consisted of 5 initial doses every 4 weeks, followed by 4 doses every 8 weeks.

Patient demographics were well-balanced between groups, with a median age of 63 years and most participants being White (64.4%) or Asian (35.6%). The majority (58.3%) were male, and nearly all had type 2 diabetes mellitus (93.1%). Baseline characteristics, including BCVA scores and central subfield thickness (CST), were comparable between groups.

The primary end point was the change in BCVA from baseline at week 8. Secondary end points included additional BCVA measures, retinal thickness, and diabetic retinopathy severity. Safety assessments included adverse events (AEs), with special focus on IVT-related AEs and immunogenicity. PK evaluations were performed in a subset of patients.

Therapeutic equivalence was demonstrated for the primary end point, with the change from baseline in BCVA at week 8 showing an estimated treatment difference of 0.58 letters (95% CI, −0.73 to 1.88) for the full analysis set. Results were consistent in sensitivity and per-protocol analyses. Both treatment groups exhibited comparable improvements in BCVA through week 24, stabilizing after week 16. Secondary end points—including proportions of patients with 5 to 9, 10 to 14, or 15 or more letter gains and at least 2-step score improvements on the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale—were similar between groups. Mean central subfield thickness (CST) reduction was slightly greater in the CT-P42 group, but overall CST values were comparable at all post-treatment visits.

The PK analyses, conducted for 23 patients, showed similar maximum drug concentration and time to peak drug reaction between groups, with no notable plasma accumulation. Usability assessments confirmed successful administration of all injections at week 0 without errors in both groups.

Safety profiles were comparable, with 50.3% of CT-P42 and 53.7% of reference aflibercept patients experiencing treatment-emergent adverse events (TEAEs), most of which were grade 1 or 2 in intensity. The proportion of ocular TEAEs was slightly lower in the CT-P42 group. These findings support the therapeutic equivalence, similar safety profiles, and usability of CT-P42 compared to reference aflibercept.

Limitations of the trial included a small PK analysis group, limited racial diversity among participants, and data availability only up to week 24. “Future studies should look to gather evidence to further investigate the long-term efficacy and safety of CT-P42 in routine clinical practice after marketing approval,” the authors concluded.

1. Wolf S. Stanga P-E, Veselovsky M. Biosimilar candidate CT-P42 in diabetic macular edema: 24-week results from a randomized, active-controlled, phase III study. 

. 2024;8(12):1163-1173. doi:10.1016/j.oret.2024.06.013

2. Biosimilar approvals. The Center for Biosimilars

. Updated December 16, 2024. Accessed. January 3, 2025. 

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

3. Jeremias S. Eye on Pharma: aflibercept legal drama; PBM, Humira biosimilars; denosumab regulatory review. The Center for Biosimilars. October 15, 2024. Accessed January 3, 2025. 

https://www.centerforbiosimilars.com/view/eye-on-pharma-aflibercept-legal-drama-pbm-humira-biosimilars-denosumab-regulatory-review

4. Diabetic macular edema (DME) fact sheet. Genentech. Accessed January 6, 2025. 

https://www.gene.com/patients/disease-education/diabetic-macular-edema

The phase 3 trial 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.

Study Confirms CT-P42 Therapeutic Equivalence to Reference Aflibercept in DME

China’s National Medical Products Administration (NMPA) has approved the cetuximab beta injection (Enlituo; formerly CMAB009) in combination with leucovorin, fluorouracil, and irinotecan (FOLFIRI) for marketing as a first-line treatment in 

 wild-type metastatic colorectal cancer (mCRC), according to an announcement from Simcere Zaiming.

This cetuximab biosimilar is a recombinant EGFR monoclonal antibody independently developed in China that was designed to effectively avoid glycosylation modification leading to hypersensitivity in patients receiving the drug.

This regulatory decision, made on June 25, 2024, was supported by results from both a phase 2/3 study and a phase 3 confirmatory clinical trial. In the prospective phase 3 study, the addition of cetuximab beta to FOLFIRI significantly increased the median progression-free survival (PFS) to 13.133 months vs 9.567 months with FOLFIRI alone in patients with 

 = .004). Additionally, the combination produced an objective response rate (ORR) of 69.1% and a median overall survival (OS) of 2.322 years. The corresponding ORR and median OS with FOLFIRI was 42.3% (

The marketing application for cetuximab beta was previously accepted by the NMPA in March, 2023. On August 18, 2023, drug developer Simcere Pharmaceutical Group entered into a cooperation agreement with Mabpharm Limited and obtained the exclusive commercial rights to this drug in the Chinese mainland.

“It’s initial indication for colorectal cancer addresses a large patient population,” Dr Renhong Tang, chairman of Simcere Zaiming, emphasized in a news release. “The product synergizes well with Simcere Zaiming’s existing offerings, and efforts are underway to accelerate its commercialization, benefiting more [patients with] cancer.”

“This provides clinicians and patients with updated therapeutic options. By collaborating with Simcere Zaiming’s Marketing Team, we are able to rapidly realize the clinical value of Enlituo, benefiting hundreds of thousands of patients in China with an effective and affordable biological new drug,” Dr Hao Wang, chief executive officer of Mabpharm, added.

The open-label, randomized, controlled, multicenter, prospective phase 3 study is enrolling patients between 18 and 75 years of age with histologically confirmed adenocarcinoma of the colon or rectum that is 

 wild-type. Patients are also required to have 1 or more measurable lesions by CT or magnetic resonance imaging according to RECIST v1.1; an ECOG performance status of 0 or 1 at trial entry; and a life expectancy of at least 3 months. Prior radiotherapy or surgery in the 30 days before trial treatment and inadequate hepatic, marrow, renal, or liver function will exclude patients from the study.

Upon enrollment, patients are randomly assigned to receive the combination or chemotherapy alone. In addition to the FOLFIRI regimen, patients in the combination arm will also receive cetuximab beta at an initial dose of 400 mg/m2 and subsequent 250 mg/m2 doses every 7 days. Treatment will continue until disease progression, withdrawal of consent, or unacceptable toxicity.

The study’s primary end point is PFS per RECIST v1.1. Key secondary end points include best ORR, OS, duration of response, and quality of life assessment.

Simcere Zaiming announce approval of cetuximab beta in China by the NMPA. News release. Simcere Zaiming. June 26, 2024. Accessed June 26, 2024. https://www.simcere.com/en/news/detail.aspx?mtt=459#:~:text=On%20June%2025%2C%202024%2C%20Simcere,in%20collaboration%20with%20Mabpharm%20Limited%20(

CMAB009 combined with FOLFIRI first-line treatment in patients with RAS/​BRAF wild-type, metastatic colorectal cancer. ClinicalTrials.gov. Updated April 10, 2024. Accessed June 26, 2024. https://clinicaltrials.gov/study/NCT03206151

First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.

Cetuximab Biosimilar Receives NMPA Approval for RAS/BRAF Wild-Type CRC

The biosimilar ocrelizumab candidate (Xacrel) was found to be equivalent to the originator product (Ocrevus) in reducing the annualized relapse rate and showed comparable safety and efficacy over 96 weeks in patients with relapsing multiple sclerosis (RMS), as confirmed in a 

The randomized, 2-armed, double-blind, phase 3 study from Iran (

, was conducted to assess the equivalency of the biosimilar ocrelizumab candidate to the originator product in reducing the annualized relapse rate (ARR) in patients with RMS, highlighting the importance of increasing patient access to effective, cost-efficient treatments for a disease that significantly impacts global health.

MS is an autoimmune disease affecting around 3 million people globally, characterized by immune cells attacking the central nervous system's myelin, leading to disability.

 MS can cause cognitive impairment, fatigue, and various other symptoms. It is classified into relapsing-remitting, secondary progressive, and primary progressive forms. High-efficacy disease-modifying therapies (DMTs) are used to manage MS, with B cell-targeting treatments like ocrelizumab showing effective results in reducing relapse rates. Biosimilars offer a way to increase access to MS treatments, especially in lower-income areas.

The study was conducted between August 2019 and October 2021 across 15 centers in Iran. It involved adult patients with RMS who met specific inclusion criteria. Participants were randomly assigned (1:1) to receive either 300 mg of Xacrel or Ocrevus for the first 2 doses (administered every 2 weeks), followed by 600 mg every 24 weeks for 96 weeks.

Prior to each infusion, patients received 100 mg intravenous methylprednisolone, an antihistamine (chlorpheniramine), and an antipyretic (acetaminophen) to minimize infusion reactions.

The primary goal was to evaluate the equivalency of Xacrel to Ocrevus in reducing the ARR at week 48. Secondary outcomes included disability progression, relapse-free patients at 96 weeks, and MRI changes in brain lesions. Safety was assessed through the incidence of adverse events (AEs) and infusion reactions.

Randomization was stratified by baseline disability status (EDSS), and participants were blinded to the treatment arm. Statistical analyses included Poisson regression, Cox regression, and Kaplan-Meier methods for the primary and secondary outcomes, ensuring equivalency between the 2 treatments.

A total of 170 patients were enrolled (85 per treatment group), with a 10% dropout rate accounted for. Patients had to be 18 to 55 years of age and have a history of at least 2 documented relapses in the last 2 years or 1 documented relapse in the last year before the screening visit.

The primary efficacy measure, the ARR at 48 weeks, showed similar results between the 2 groups. In the per-protocol (PP) set, the ARR for Xacrel was 0.067 (95% CI, 0.029-0.155), and for Ocrevus, it was 0.070 (95% CI, 0.031-0.158), with no significant difference (95% CI, −0.080 to 0.075; 

 = .95). The results were consistent in the intent-to-treat (ITT) set, where the ARR was 0.065 for Xacrel (95% CI, 0.028-0.149) and 0.068 for Ocrevus (95% CI, 0.030-0.153), again showing no significant difference (95% CI, −0.078 to 0.072; 

Over the 96-week period, the confirmed disability progression rate at 12 weeks was 7.06% for Xacrel and 5.90% for Ocrevus (

 = .71), and at 24 weeks, it was 7.06% for Xacrel and 2.35% for Ocrevus (

 = .16). Regarding relapse-free rates at 96 weeks, 89.41% of patients in the Xacrel group and 87.10% in the Ocrevus group remained relapse-free (

 = .63). In MRI assessments, the mean number of new or enlarging T2 hyperintense lesions was 0.16 for Xacrel (95% CI, 0.08-0.33) and 0.08 for Ocrevus (95% CI, 0.03-0.20), with no significant difference (

 = .21). The volume of T2 lesions decreased similarly in both groups (Xacrel, −0.60; Ocrevus, −0.70; 

Regarding safety, 97.65% of patients in both groups experienced at least 1 adverse event (AE), with infusion-related reactions being the most common. In total, 24 serious AEs (SAEs) were reported, with 6 in the Xacrel group and 15 in the Ocrevus group. There was no significant difference in the incidence of SAEs between the 2 groups. Serious infections occurred in both groups, including cases of coronavirus, pharyngitis, urinary tract infection, and appendicitis.

No positive samples for anti-ocrelizumab antibodies were found in the immunogenicity assessment, indicating no immunogenic response to Ocrevus. A post hoc analysis of ARR at 96 weeks revealed no significant difference (Xacrel, 0.122; Ocrevus, 0.124; 

 = .82), and the proportion of patients with CD19 levels below 1% at least once was similar between the 2 groups (Xacrel, 64.71%; Ocrevus, 63.53%; 

The study had limitations. The COVID-19 pandemic affected patient adherence and attendance at scheduled visits, potentially influencing results. Variability in MRI instruments between study centers could also have introduced inconsistencies in the MRI data. Despite these limitations, the results suggest that Xacrel is a viable alternative to Ocrevus in treating RMS.

1. Sahraian MA, Abolfazli R, Shaygannejad V, et al. Evaluating efficacy and safety of ocrelizumab biosimilar (Xacrel) compared to the originator (Ocrevus) in relapsing multiple sclerosis: a phase III, randomized, equivalency, clinical trial. 

. 2024;14(1):24921. doi:10.1038/s41598-024-75745-y

2. Global Regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis for the global burden of Disease Study 2021. 

2024;23(4):344-381. doi:10.1016/s1474-4422(24)00038-3

The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.

Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment

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

 of affordable biosimilars, with varying impacts across different jurisdictions.

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

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

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

Surabhi Dangi-Garimella, PhD

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