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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Prateek Yadav serves as manager of life science consulting at ZS Analysis. Yadav is a healthc are professional with nearly 10 years of experience, including 9 years in life sciences consulting. He has worked with over 15 Fortune 500 pharma companies on business strategy projects worth around $10 million annually, focusing on growing market share and improving patient outcomes.

His expertise includes competitive intelligence, landscape analysis, and strategy development across areas like vaccines, oncology, ophthalmology, inflammation, and diabetes. He also has deep experience in biosimilars and specialty drugs, focusing on market trends and assessments in the US, European Union, and Southeast Asia.

Prateek has spent over 5 years as a delivery lead and main client contact, helping solve complex challenges and providing research and consulting services to pharma companies.

Articles

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

The Next Frontier: Oncology Biosimilars in 2025 and Beyond 

Korean drugmakers hold over 50% market share in the 6 best-selling biosimilar markets, 2 companies sign exclusive licensing partnership for a denosumab biosimilar, and 2 others join forces for an eculizumab biosimilar.

Eye on Pharma: Korean Drugmakers’ Impact in Europe; New Denosumab, Eculizumab Deals

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Here are the top 5 biosimilar articles for the week of January 6, 2025. 

The Top 5 Biosimilar Articles for the Week of January 6

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

Earlier Patent Litigation Could Accelerate US Biosimilar Market Entry

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1rem

There are several pending legislative proposals in both the House of Representatives and the Senate designed to encourage more commercialization of biosimilars, but the 2020 election may determine their timing.

Election May Determine Pace of Biosimilar Legislation

Depending on the outcome, 3 major biosimilar antitrust actions, as well as a related Federal Trade Commission investigation, could significantly change how biologics are priced.

Pending Antitrust Actions Could Change Biosimilar Dynamics

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.

Clinical

Business & Practice

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.

Veterans with inflammatory bowel disease (IBD)

 prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.

To read all of these articles and more, visit 

Video Series

The Top 5 Biosimilar Articles for the Week of December 2

Biosimilars offer critical savings and increased access to treatments, but they face substantial barriers before reaching patients. This series for Global Biosimilars Week, a worldwide online biosimilar advocacy event hosted by the International Generics and Biosimilars Association, focuses on 3 major areas where obstacles limit access in the US:

Payer and pharmacy benefit managers (PBMs) policies

 is a media partner for Global Biosimilars Week 2024. Each article in this series will shed light on these barriers and suggest steps to enhance biosimilar access, affordability, and equity.

Dancing With the Companies: The Patent Dance and Biosimilars

The "patent dance" is a structured legal process unique to the biosimilar landscape in the US, designed to help streamline patent disputes between biosimilar manufacturers and reference product sponsors.

 Created as part of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, the patent dance aims to expedite biosimilar entry into the market while balancing the interests of innovators who initially developed these complex biologic therapies.

Currently, the patent dance is a required part of the biosimilar approval pathway and involves an exchange of information regarding patents, infringement, and validity positions 

. This early assessment, often initiated even before any litigation is filed, allows the involved parties to pinpoint and discuss specific patents that might be contested, facilitating earlier settlement discussions and minimizing the scope of costly litigation.

Patent litigation is often resource intensive on both sides. 

 with The Center for Biosimilars, Ha Kung Wong, JD, an intellectual property attorney and partner at Venable, noted that the patent dance has been instrumental in promoting settlements, reducing the need for many cases to proceed to trial.

“The patent dance allows for an early assessment of infringement and validity positions... If you don’t have a problem with the patents, then you can launch without any risk... It’s led to a great number of settlements, very few of them go to trial, which means we're not wasting resources on litigation,” he said.

Although this system has proven effective in fostering negotiation and settlement—ultimately helping to speed up biosimilar market entry—it is not without its criticisms. Some industry stakeholders argue that the BPCIA framework could be further streamlined to make the process less cumbersome and more predictable for biosimilar developers.

 As it stands, however, the patent dance remains a pivotal aspect of the biosimilar approval process, as it narrows down relevant patents and reduces potential legal roadblocks, benefiting both biosimilar manufacturers and original biologic developers.

In essence, the current state of the patent dance in the biosimilar landscape reflects an ongoing effort to balance innovation protection with the need to improve market access and affordability for biologic therapies. This system, while complex, is considered one of the primary drivers of efficient biosimilar development in the US, fostering a competitive landscape that promises greater access to these critical medicines for patients.

But, is the patent dance working? Is it helping biosimilars? What needs to be done to ensure innovation and competition aren’t hindered?

Patent Disputes Leading to Delayed Entries

The US patent system allows drug companies to obtain preliminary patents to obtain market exclusivity on a particular product, as well as patents on aspects like the manufacturing process, device design, development process, and others. This enables companies to create a wall of patents—in some cases, over 100 patents—that can be very difficult for biosimilar and generic manufacturers to comb through.

This creates an environment where originator companies are almost guaranteed to sue their future biosimilar competitors, resulting in launch delays.

Product launch delays leave the door open for companies to enact product hopping, when drug companies shift demand from an innovator drug facing or about to face generic or biosimilar competition to new, patented versions.

Although the first patents for the reference product Humira expired in 2018, biosimilar versions were not allowed to enter the market until 2023, with most not being able to launch until the second half of the year.

Humira’s maker, AbbVie was able to use patent legislation and pay-for-delay deals to get biosimilar companies to postpone launch dates.

 These lawsuits resulted in mass settlements with all adalimumab biosimilar manufacturers coupled with the promise not to launch until 2023, with Amgen’s Amjevita (adalimumab-atto) being the first to launch. Amjevita launched at the end of January 2023, followed by 7 products in July, 1 in October, and 1 in 2024.

The adalimumab biosimilar market has the highest number of products competing against a single originator, and most of the products launched in a 6-month span, the effects of which the US is still trying to observe. Already the delays have enabled AbbVie to convert a lot of its patients from Humira to Skyrizi (rizankizumab-rzaa), another one of its products.

 Although adoption of adalimumab biosimilars has grown significantly throughout 2024, the adalimumab market as a whole is shrinking due to patients switching to another AbbVie product instead of a biosimilar, leaving the sustainability of biosimilars in this space and others in limbo.

Similarly, this has happened with ustekinumab biosimilars, which, thanks to multiple settlements with reference manufacturer Johnson & Johnson, will not launch in the US until early 2025.

 This was pushed back from the initial launch prediction of late 2023 or early 2024.

Aflibercept biosimilars also have been postponed due to litigation. However, in September 2023, a federal judge in West Virginia ruled that originator manufacturer Regeneron cannot immediately restrict Amgen’s US sales of a biosimilar to Eylea (reference aflibercept).

 Aflibercept biosimilars were supposed launch in 2024 but are now expected to start launching in 2025.

The postponement of ustekinumab, aflibercept, and other molecules creates an opportunity for companies to stifle competition and savings for patients by preventing access to lower-cost medications.

Additionally, patent litigation is very expensive for biosimilar manufacturers. Negotiation for settlements coupled with delayed profits from postponing a market launch can make pursuing biosimilar development very unattractive. In fact, 47% of the originator molecules with the potential to have biosimilars in the future do not have biosimilars in development, raising the question of whether companies will continue to see revenue potential from the biosimilar space.

Without policy reform and action, how can biosimilar companies keep up? And how can industry leaders prevent companies from feeling so discouraged by patent hurdles and delayed returns that they consider leaving the biosimilar market for good?

Several policy initiatives aim to promote fair competition in the pharmaceutical market, which is a start. In 2022, Congress directed the Federal Trade Commission (FTC) to address product hopping, leading to an FTC report that highlighted antitrust concerns with brand name companies’ efforts to obstruct competition between original and reformulated drugs.

In January 2023, Senators John Cornyn (R, Texas) and Richard Blumenthal (D, Connecticut) introduced the Affordable Prescriptions for Patients Act of 2023 (S 150).

 The bill, which passed the Senate in July 2024, would ban product hopping and cap the number of patents a brand company can assert against a generic or biosimilar manufacturer at 20, with specific rules for adding new patents. However, Wong questioned whether this would have a practical effect, noting that most lawsuits are based on fewer than 10 patents.

Alas, like most biosimilar reforms in Congress, these pieces of legislation have been stalled, often trapped in committee hearings or on desk holds. Wong commented on the prospect of policy reforms making it out of congressional limbo to address ongoing challenges with the patent system and biosimilars: "Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next Fast & Furious movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world."

Wong recommends that policymakers and other industry leaders keep in mind how patent reforms will impact the entire system and ensure that new policies aren’t implemented haphazardly.

"Reforms, like limiting the number of patents that can be asserted in a patent litigation, might have some effect, but we haven't seen significant changes yet. The challenge is that patents are often filed early in the development process, so it's unclear whether reform would make a big difference for biosimilars unless there are substantial follow-through actions."

1. Menchaca A. The inner workings of the BPCIA patent dance. The Center for Biosimilars. July 24, 2021. Accessed November 7, 2024. 

Part 1 of this 3-part series for Global Biosimilars Week focuses on legal barriers to biosimilar access in the US, including the patent system, and discusses ongoing legislative efforts to address these challenges.

Ron Lanton III, ESQ

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