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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

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

Articles

Celltrion expands its reach in Europe, securing marketing authorization from the European Commission (EC) for its denosumab biosimilar candidate (Stoboclo and Osenvelt) and its aflibercept biosimilar (Eydenzelt).

EC Approves Celltrion Denosumab, Aflibercept Biosimilars

The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.

FDA, EMA Approve Second Pair of Denosumab Biosimilars

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

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Travis Brewer serves as the vice president of payer and public health strategy at Texas Oncology.

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.

Enhancing Biosimilar Adoption in Value-Based Oncology Care

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, highlighted biosimilars' role in making cancer care more affordable and accessible, especially for underserved populations. He stressed the need to balance cost-effectiveness with efficacy and called for greater payer trust in oncologists' biosimilar selections. Brewer also advocated for expanding "gold carding" to reduce prior authorization hurdles, promoting smoother biosimilar adoption in value-based care models.

This transcript has been edited for clarity; captions were auto-generated.

In a value-based oncology care model, what role do biosimilars play in ensuring equitable access to cancer treatments, especially for underserved patient populations?

Well, to the extent that you have, , biosimilars available, that that may be more cost effective, yet equally efficacious, relative to a particular treatment regimen, I think that goes a long way. Going back to the original cost-containment idea, so the more affordable you can make cancer care, the more accessible it is to to to broader populations.

That said, it's not always the best idea to just pick the cheapest if the cheapest isn't the best. You have to balance that with the efficacy of the treatment.

Can value-based oncology care models incentivize more rapid biosimilar uptake, and if so, what mechanisms should be in place to ensure their successful implementation?

That's really where the payers come in. We, as a practice, do a very good job of monitoring what's available on the market, what is the most efficacious, and then balance that with what is the most cost-effective. Unfortunately, at times we'll find that what we think the correct answer is, is not what the payer prefers, and the payer prefers brand B, C, or D.

And then it becomes a little difficult from a practice management perspective to keep on hand every "flavor" of biosimilar that's out there. I've told payers before we are not Baskin-Robbins. We don't carry all the flavors. That can lend itself to some conflicts with the payer.

So, I think the payers opening themselves up to trusting the community oncology providers a little more relative to the selection of biosimilars would go a long way in this space.

How do current reimbursement policies and payer models impact the integration of biosimilars into value-based oncology care, and what changes are necessary to promote their wider adoption?

I think opening up some of the prior authorization guidelines, more gold carding for trusted physician groups. I push for a gold card every chance I get, and I have absolutely no issue with with a payer coming back on the back end and saying, "Okay, well, let me take a look at 10- year files and see if it's not the fox guarding the hen house here."

We really are doing the right things for the right reasons. So, I think there's an opportunity to partner more with the payers on that front and get the payers to back off. And the best way to get them to back off is to show that we are consistently providing the highest-value care in the most cost-effective manner.

Clinical

Biosimilars are increasingly recognized for their potential to reduce healthcare costs and expand patient access to life-saving treatments. However, several economic and policy-related factors influence their adoption and overall impact on the health care system. To explore these critical dimensions, 

) spoke with James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies.

Chambers leads the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the Medicare National Coverage Decisions Database, making him a key expert in analyzing drug policy, reimbursement trends, and health care economics. He's also partnering with Organon to share his insights as a health economist around the complex landscape of biosimilars. In this discussion, Chambers shares insights on the economic factors shaping biosimilar adoption, the barriers preventing wider uptake, and how these therapies can contribute to cost savings and improved patient access.

"What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century: a paradigm shift that may deliver more competition, increase treatment options, and may help lower costs to the health care system." — James D. Chambers, PhD, MPharm, MSc

: What role do value-based pricing models play in facilitating the integration of biosimilars into health care systems, and how can these models be optimized to better reflect the broader economic benefits?

Value-based pricing models align product pricing with the clinical and economic value offered by biosimilars. The potential value of biosimilars in today's health care landscape is significant, as adoption may help reduce the affordability burden to the health care system. Additionally, biosimilars have similar safety and efficacy compared with the reference products and help promote affordability and support health care system sustainability. This is especially critical given the fact that a significant number of patients who need biologic treatments suffer from a chronic disease requiring lifelong management that, historically, may have come with high out-of-pocket costs, even after insurance, and could place additional strain on the health care system. Value-based pricing models can help encourage the adoption of biosimilars by mitigating the financial uncertainties linked to biologic therapies.

: What steps can health care systems take to maximize the cost-saving potential of biosimilars while ensuring they are accessible to all patients?

While biosimilars may help reduce costs to the health care system and potentially increase access to medicines, there is no single solution; it’s a multifactorial issue that requires alignment of key stakeholders, such as physicians, payers, and pharmacy benefit managers (PBMs) alike, to usher in necessary adoption, but it’s only through aligned and collaborative efforts that we can unlock the potential value that biosimilars can create.

This also means an increase in provider education to address misconceptions about biosimilars, and the implementation of patient awareness campaigns to alleviate concerns about switching from originator products. For health care payers, it is crucial to designate biosimilars as preferred treatments in formularies and streamline prior authorization processes to facilitate their access.

: Given your expertise in health economics, what do you foresee as the biggest challenges and opportunities for biosimilars in the next 5 to 10 years?

What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century: a paradigm shift that may deliver more competition, increase treatment options, and may help lower costs to the health care system. There are points of evidence that support that the US is seeing benefits to the health care system and to patients and the growing adoption of value-based pricing models, including outcomes-based reimbursement models, can drive biosimilar use.

For example, in a recent 2024 study my team conducted using biosimilar products in rheumatology and oncology, trends were uncovered in payer coverage, market share, and pricing that reveal that biosimilar availability has yielded cost savings despite the adoption of different coverage strategies by originator product manufacturers.

Another opportunity is the generation of robust real-world evidence, which is has the potential to demonstrate biosimilar cost-effectiveness and the impact on health care budgets.

But we still have work to do. We need to tackle some of the observed barriers— from rebate tactics and the lack of physician biosimilar familiarity, as these factors directly influence the adoption of biosimilars.

Additionally, there is growing concern that the Inflation Reduction Act (IRA), which introduces Medicare price negotiations for certain drugs, may unintentionally limit originator biologic prices. This could cap potential earnings for biosimilar manufacturers, thereby weakening the financial incentives necessary for continued biosimilar development.

Another challenge lies in the lack of clear interchangeability guidelines in some jurisdictions. This ambiguity complicates biosimilar substitution at the pharmacy level, hindering widespread adoption and undermining their cost-saving potential.

: What is the role of biosimilars in addressing healthcare disparities, particularly in resource-constrained settings, and how can health care systems ensure equitable access while maintaining cost-efficiency?

Biosimilars have the potential to lower costs and improve access, enabling health care systems to reduce disparities in care delivery and advance equity. While biologics may only account for 2% of all prescriptions, they represent about $120 billion or 37% of net drug spending since 2014. We know biosimilars increase competition and can undercut reference product prices, thereby potentially reducing spending on treatment and increasing access, but in order for biosimilars to support health care disparities, there has to be support across all facets of the health care system—physicians, payers, and PBMs are just a few—to unlock their potential.

Health care systems can help ensure equitable access to biosimilars by centralizing procurement to enhance affordability, establishing clear interchangeability guidelines for quicker adoption, and conducting targeted education campaigns to build trust and acceptance.

: In light of evolving regulatory frameworks and changing global market dynamics, how can we future-proof biosimilars against potential policy shifts that may affect their pricing and accessibility?

There are always shifts on the horizon, no matter the market dynamics, and because addressing barriers to adoption is a multifactorial issue, the first step is always vigilance to understand which part of the health care system may be affected and if there is an expected spillover. From there, we have to work together to understand how these policy shifts may impact biosimilars and protect them from getting lost in red tape. We know that without competition from biosimilars, reference product prices were predicted to continue to increase as they historically have, further limiting patient access to treatments, so future-proofing biosimilars is critical to ensuring the health care system—and in some cases patients—continue to reap the benefits.

As noted earlier, the concern that the IRA could weaken financial incentives for biosimilar development highlights a potential unintended consequence of evolving regulatory frameworks.

: What challenges do you anticipate in the pricing and reimbursement landscape for ustekinumab biosimilars in the US, particularly in terms of insurer acceptance and patient access, given the history of similar biologics entering the market?

With entry into the US market, we can expect biosimilars to continue to face many of the same barriers and hurdles as those that have come before—particularly in terms of insurer acceptance. There are vast variations in how biosimilars are covered, compared to reference products, by commercial health plans.

For example, in 2019 my team conducted a study that found that US health plans covered biosimilars as “preferred” in only 14% of decisions. In 2023, another study we conducted found that among all biosimilar coverage decisions, 19.4% were covered more restrictively than their reference products. So, insurer acceptance has remained a large barrier to cross—in large part due to things like rebate walls, manufacturer negotiation power and the order in which a biosimilar enters the market. These challenges can create downstream impacts on patients, whose ability to benefit from biosimilars may depend on their health plan, potential cost savings, and their physician's knowledge and willingness to prescribe biosimilars.

That said, biosimilars of today are in a better place than they were in terms of physician/patient education and general understanding, and we have data to support that they make an impact on the health care system, and in some instances, patients. We are seeing estimated savings in the billions: from 2021 to 2025, biosimilars are estimated to save $38.4 billion to the health care system, if adopted. We are also seeing more sustained medication use thanks to biosimilars: the use of biosimilars has increased patient access, supporting more than 344 million incremental days of therapy. Biosimilars are helping to make it possible for patients to access and maintain consistent treatment—trends we anticipate will strengthen over time.

Biosimilars have the potential to reduce health care costs 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.

Business & Practice

The Banking of Biosimilars: Insights From a Leading Health Economist

 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.

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.

Travis Brewer

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