Justina Petrullo

A study showed that a proposed biosimilar of 

 (BAT1706) comparably matches with reference bevacizumab (EU/US-sourced Avastin) in terms of physiochemical and functional qualities reviewed, according to 

A thorough physicochemical and functional similarity study is a necessary part of showing biosimilarity between a reference biologic and a proposed biosimilar and was carried out for BAR1706 and reference bevacizumab.

Reference bevacizumab is a vascular endothelial growth factor (VEGF)- targeting biologic used to treat multiple cancers, including metastatic colorectal cancer.

Study authors reported on the physiochemical and functional similarity of BAT1706 and reference bevacizumab obtained from the United States (US-bevacizumab) and the European Union (EU-bevacizumab).

First, a wide range of product qualities, including primary and higher order structure, post-translational modifications, purity, stability, and potency, were characterized for BAT1706 and EU/US-sourced reference bevacizumab using sensitive state-of-the art analytical methods. Up to 18 lots of US-bevacizumab and 29 lots of EU-bevacizumab, and 10 unique drug substance lots of BAT1706 were evaluated.

BAT1706 presented an identical amino acid sequence and an indistinguishable higher-order structure compared with EU/US-sourced reference bevacizumab. BAT1706 and EU/US-bevacizumab also showed similar post-translational modifications, glycan profiles, and change variants. Potency was evaluated through a large range of bioassays and also displayed comparably between BAT1706 and EU/US-bevacizumab, with statistical equivalence showed for VEGF-A binding and neutralizing activity.

A risked-based tier approach was used for all attributes and offers a systematic way to review analytical similarity with a high confidence level and low potential for bias.

“Greater than 90% of the measured biological activities of all BAT1706 lots fall within the range of the quality range of EU/US-bevacizumab (mean 3 AU),” said the study authors.

These results strongly back the deduction that BAT1706 shows highly similar functional properties compared with reference bevacizumab.

Furthermore, quality range and visual comparison analyses showed that BAT1706 and reference bevacizumab have identical primary structures and indistinguishable higher-order structures, and highly similar purity profiles and charge isoforms.

Small differences in the ratio of galactosylation and afucosylation were found, but not expected to affect clinical safety and efficacy.

Additionally, the stability of BAT1706 and EU/US-bevacizumab was reviewed in a series of degradation experiments. The degradation pathways and degradation rates were shown to be similar for BAT1706 and the reference bevacizumab under all conditions measured.

“In conclusion, the current demonstrated and positive regulatory biosimilarity review, regardless the minor differences were observed, but these differences were not clinical meaningful, therefore it can be concluded that overall product quality of BAT1706 can be considered highly similar to EU/US Bevacizumab,” said the study authors.

Cao D, Deng C, Wang G, et al. Physicochemical and functional similarity assessment between proposed bevacizumab biosimilar BAT1706 and reference bevacizumab 

. Published online June 26, 2023. Accessed July 26, 2023. doi:10.1007/s40268-023-00432-8

Articles

Reference bevacizumab and proposed biosimilar (BAT1706) demonstrate high similarity to each other.

Reference Bevacizumab and Proposed Biosimilar Show High Similarity

Hi, I’m Justina Petrullo for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of July 17th, 2023.

Number 5: A review article shed light on the 

, including how these products are being priced, strategies companies are using to make their product stand out, and recommendations for policymakers to ensure the accessibility and affordability of these products.

 for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.

reintroduced the Biosimilar Red Tape Elimination Act

 to Congress. The bill aims to get rid of switching study requirements for companies looking to obtain an interchangeability designation for a biosimilar.

The US gained 2 more adalimumab biosimilars

 on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches came after 5 launched over the Fourth of July weekend.

Number 1: The list price of Humira (reference adalimumab) had 

 over time that the list prices for new adalimumab biosimilars are now significantly higher than the original price of the originator, according to a report contextualizing net prices of adalimumab and the role of rebates.

To read all of these articles and more, visit 

Videos

Here are the top 5 biosimilar articles for the week of July 17, 2023.

The Top 5 Biosimilar Articles for the Week of July 17

Even with clear clinical guidelines present, former studies show that up to 28% of patients with monoclonal antibody human epidermal growth factor receptor 2 (ERBB2)-overexpressing early-stage breast 

 do not receive ERBB2-targeted therapy, and that cost is the greatest cited hurdle, especially in low- and middle-income countries, according to a review in 

The United States also perceives racial inequities whereby Black patients, who are disproportionately laden with financial toxicity and other structural blocks to cancer care, are less likely to receive reference trastuzumab, an ERBB2 antagonist.

Biologics like trastuzumab are the fastest growing medication class in the country and make up a growing portion of health care costs.

Biosimilars hold the possibility to reduce or worsen health inequalities depending on if studies supporting regulatory approval dismiss marginalized populations and could impact external validity and if update continues across racial and ethnic populations. Introduction of trastuzumab biosimilar SB3 (Ontruzant) could save costs and promote access.

“The entry of oncology biosimilars such as SB3 into a stable, competitive market represents a potential for cost savings and increased access to these treatments, especially among patients for whom cost is a barrier to receipt of optimal therapy,” said the researchers.

Therefore, the researchers affixed a health equity lens to the assessment of biosimilar safety while considering long-term follow-up studies of oncology biosimilars and their corresponding external validity relative to health equity.

The authors cited a report (Pivot et al) assessing the results of a phase 3 randomized trial of SB3, a trastuzumab biosimilar approved by the FDA in 2019, in the largest and longest follow-up study to date comparing cardiac safety and survival with its originator, reference trastuzumab.

A graphic of a heart hovers over a person's hands. 

The primary outcomes present in this cardiac safety investigation were incidences of symptomatic congestive heart failure and asymptomatic significant decrease in left ventricular ejection fraction with a median follow-up of 68 months.

A subset of 367 participants in the phase 3 trial who were supervised for cardiac safety outcomes, wherein no symptomatic congestive heart failure was seen in either the SB3 or trastuzumab groups and only 3 asymptomatic significant left ventricular ejection fraction decreases were reported, with 1 in the SB3 group and 2 in the trastuzumab group.

The cohort primarily consisted of White and Asian American patients and did not include any Black or Latin American (Latinx) patients. Additionally, although 20% of the cohort was Asian American, very few were of South Asian descent.

These findings came in stark contrast with the significantly increased risk of congestive heart failure (relative risk [RR], 5.11; 90% CI, 3.00-8.72; 

 < .00001) and left ventricular ejection fraction decline (RR, 1.83; 90% CI, 1.36-2.47; 

 = .0008) reported in a meta-analysis or prior trastuzumab clinical trials.

Pivot et al indicated that the reasons for lower rates of cardiac events in this setting include cardiac monitoring procedures with early stopping issues, and stringent inclusion criteria for the study. The overall presence of cardiovascular disease (coronary artery disease, 3.90%) and conditions representing cardiovascular risk factors (obesity, 4.46%; diabetes, 2.60%; and hypercholesterolemia, 1.12%) were very low.

Even though an absence of serious cardiac events seen over 5 years of follow up is heartening, researchers are becoming more and more cognizant of cancer treatment-related cardiotoxic effects when reviewed in clinical practice, where cardiovascular risk factor rates and cardiovascular mortality are substantially higher and disproportionately affect historically marginalized racial and ethnic groups.

This study adds necessary pharmacovigilance data on Asian patients with breast cancer, a group seen to have higher risk of ERBB2-overexpressing breast cancer in the US, because approximately 20% of patients in both the control and treatment groups were of Asian descent.

“However, no Black or Latinx participants were included in this biosimilar safety analysis, and few South Asian participants were represented, all of which are populations with higher rates of cardiovascular morbidity and high incidence of cardiovascular toxic effects following anti–ERBB2-targeted therapies,” said the researchers.

In 2022, the FDA announced draft guidance on diversity plans to improve participant enrollment from historically excluded communities in clinical trials and will signify a mandate for drug sponsors in 2024.

Prior to conducting a study, the researchers emphasize that enrollment can be optimized by prioritizing health equity and include historically excluded racial and ethnic populations in the beginning in the prospective evidence generation life cycle.

Some limitations of study consisted of the lack of external validity for Black and Latinx patients who are both at higher risk of cardiovascular toxic effects and have the least access to ERBB2-targeted therapy and may have the most possible benefit from increased affordability.

“We highlight the potential of empirical data for retrospective and prospective evidence generation to address a root cause of persistent cancer health inequities,” concluded the researchers.

Calip GS, Altomare IP, Guadamuz JS. Evaluating external validity of oncology biosimilar safety studies. 

. Published online April 6, 2023. Accessed July 18, 2023. doi:10.1001/jamanetworkopen.2023.5776

Biosimilars may be able to increase treatment access for traditionally excluded communities, especially racial and ethnic minority populations.

Biosimilars Can Expand Treatment Access for Traditionally Excluded Communities

Here are the top 5 biosimilar articles for the week of July 10th, 2023.

 where stakeholders can make public comment on whether clinical efficacy testing for biosimilars is necessary for regulatory approval.

 in the United States, Yuflyma (adalimumab-aaty), a biosimilar referencing Humira that is also 1 of 8 adalimumab products expected to launch in July.

 on how to prepare for new self-administered biosimilar products, including adalimumab biosimilars, and overcome emerging administrative challenges.

 on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

Number 1: After years of waiting and legal battles, the 

 expected to launch in July 2023 have entered the market.

Here are the top 5 biosimilar articles for the week of July 10, 2023.

The Top 5 Biosimilar Articles for the Week of July 10

Numerous successive switches from infliximab originator (Remicade) to biosimilar infliximab (IFX) are safe and effective in patients with 

 regardless of the amount of infliximab switches, according to the 

This is a graphic of the stomach and intestines.

It is known that switching from Remicade to biosimilar IFX is safe and effective, but data on multiple switching is limited. The Edinburgh IBD unit had conducted 3 switch programs: 

CT-P13 to SB2 (Remsima to Flixabi; in 2020)

SB2 to CT-P13 (Flixabi to Remsima; 2021).

IBD is an umbrella term for ulcerative colitis (UC) and Crohn disease (CD).

First, the study authors stated that the primary endpoint of the study was to evaluate patient adherence to CT-P13 after switching from SB2. Secondary endpoints consisted of persistence stratified by the number of biosimilar switches (single, double, and triple), safety, and effectiveness.

“Single and double switch appeared to be effective and safe in some observational studies, but data regarding three or more switches are lacking. In the present economic climate with multiple biosimilars available at competitive prices, data about multiple biosimilar switches is of increasing importance,” they emphasized.

Then, the study authors conducted a prospective, observational cohort study. All adult patients with IBD on IFX biosimilar SB2 underwent a voluntary switch to CT-P13. Patients were evaluated in a virtual biologic clinic with protocol driven collection of clinical disease activity, C-reactive protein (CRP), fecal calprotectin (FC), IFX trough/antibody levels, and drug survival.

Next, a total of 297 patients with IBD (CD, n = 196, 66%; UC or unclassified, 

= 101, 34%) were switched with a follow-up of 7.5 (range, 6.8-8.1) months . Overall, 22.5% (n = 67) of the cohort underwent 3 switches between IFX products, 46.5% (n = 138) underwent 2 switches, and 31% (n = 92) experienced 1 switch. A total of 90.6% of patients stayed on their most recent IFX product during follow-up. 

Switch number was not independently associated with IFX persistence after cofounder adjustment. Clinical (

 = .75) and fecal biomarker (FC < 250 μg/g; 

 = .63) remission were analogous at baseline, week 12, and week 24.

In a large real-world cohort, study authors displayed that this methodology is safe and effective with similar clinical and biochemical remission rates over time, regardless of the number of switches. This new cohort displayed effectiveness and safety data to back the multiple switch approach. Other studies have supported this finding, as well.

“Immunogenicity has been a major concern regarding multiple switches, although both our study and previous literature demonstrated that this seemed to be not happening more often to patients who had multiple switches compared to those who had less number of switches or none,” said the study authors.

In the present study, 14 (7.1%) patients who developed de novo antibodies did not undergo 3 switches, suggesting that the antibody maifestation was not impacted by the switch or the biosimilar. This group might symbolize a selected cohort of patients on somewhat long-term IFX with a low immunogenicity risk.

Additionally, the study authors discovered that IFX duration rather than the number of IFX biosimilar switches as an independent predictor for IFX persistence. IFX duration and number of switches were found to be correlated.

To the best of the study authors’ knowledge, this is the first study analyzing the efficacy and safety of 3 successive switches in patients with IBD treated with IFX.

One limitation of this study is that the study design did not include a control arm that continued SB2, which obstructed the effectiveness and safety comparison between groups. Also, there was some missing data even though data were prospectively collected, that might have resulted in a conservative estimate of effectiveness outcomes.

“Multiple successive switches from the IFX originator to biosimilars appear effective and safe, irrespective of the number of switches. These findings are of major socioeconomic importance, especially in low and middle‐income countries where the access to healthcare may be limited,” the study authors concluded.

Gros B, Plevris N, Constantine-Cooke N, et al. Multiple infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort. 

. 2023;11(2):179-188. doi:10.1002/ueg2.12357

Multiple real-world infliximab biosimilar switches appear to be safe and effective in a real-world inflammatory bowel disease cohort study.

Multiple Infliximab Biosimilar Switches Were Safe, Effective

Noninferiority with comparable efficacy and safety between biosimilar romiplostim (ENZ110) and innovator romiplostim (Nplate) in patients with chronic immune thrombocytopenia (ITP) was displayed in 

Indian Journal of Hematology and Blood Transfusion

This study was conducted because biosimilar romiplostim can be made available for patients with ITP at a low cost and can be helpful in providing the best therapy. Romiplostim is approved by the FDA for ITP, and biosimilars of biologics like romiplostim may have the ability to lower health care–related costs.

“The biosimilar of Romiplostim, ENZ110, would accomplish the unmet need in the niche Indian market in patients with ITP; its introduction would be an effective treatment option due to its affordability,” said the study authors.

First, researchers aimed to determine the efficacy and safety of ENZ110 compared with Nplate with respect to platelet response in patients with chronic ITP. Next, those with chronic ITP aged 18 to 65 years were enrolled in a study and randomized to either receive ENZ110 or Nplate in a 1:1 ratio for a treatment timeline of 12 weeks. After the treatment period ended, patients were followed up with for 1 week to review the platelet response and to check for adverse events.

Over the 12 weeks, platelet response of > 50 x 10

/L was achieved in 85.3% patients treated with ENZ110 and 75.0% patients treated with Nplate in per protocol population.

“In the intent-to-treat population, 83.8% patients with ENZ110 and 76.9% patients with Nplate achieved a platelet response of > 50 x 10

In terms of safety, 129 treatment-emergent adverse events were reported by 34 (65.4%) individuals. Serious AEs were reported by 5 people, 1 of which led to death. Of the 129 TEAEs, 83 might have been associated with the study medication, 4 AEs were likely related, and 42 AEs were unlikely to be related. In the ENZ110 group, 111 AEs were recorded in 26 (66.7%) patients and 18 AEs were seen in 8 (61.5%) patients in the Nplate group. The rates of patients having at least 1 AE were similar between groups.

Despite these reported AEs, no significant differences were seen in the incidences of TEAEs between the treatment groups. The reported AEs were anticipated and constant with reference to Nplate. Treatment-emergent anti-drug antibody was identified in 2 patients (5.71%) from the ENZ110 group and 1 patient (9.09%) from the Nplate group, which was consistent with the Summary of Product information.

Additionally, since the study used a 1-mcg/kg dose of ENZ110, there was no statistically significant difference seen from baseline to week 12 for hematology and biochemistry laboratory parameters in both treatment groups.

Concerning pharmacokinetic assessment, most of the samples were reported below the lower limit of quantitation (40 pg/mL) of the assay. Therefore, the statistical analysis was not completed.

Even though romiplostim is an approved treatment for ITP, because of cost constraints in India, most people prefer immunosuppression therapy. The biosimilar of romiplostim, ENZ110, would come as a significant relief to patients with ITP since its affordability would fulfill unmet needs in patients who need the best treatment.

“This study established noninferiority, along with comparable safety and immunogenicity between biosimilar romiplostim and innovator romiplostim in patients with chronic ITP,” concluded the study authors

Chandrakala S, Toshniwal M, Halvawala M, et al. Efficacy and safety of biosimilar romiplostim versus innovator romiplostim in patients with chronic immune thrombocytopenia. 

. 2023;39(3):435-441. doi:10.1007/s12288-022-01602-5

Noninferiority and comparable safety and immunogenicity between biosimilar romiplostim (ENZ110) and innovator romiplostim (Nplate) were identified in patients with chronic immune thrombocytopenia.

Biosimilar, Innovator Romiplostim Comparably Safe and Effective

Here are the top 5 biosimilar articles for the week of July 3rd, 2023.

Number 5: It was found that cancer treatment, pediatric population, and coverage restriction of reference products were revealed as some of the 

strongest factors associated with biosimilar coverage decisions

 by US commercial health plans relative to reference products.

Number 3: In his latest column, Sarfaraz K. Niazi, PhD, took a look at 

common misconceptions about biosimilar development

 and expressed how companies can seize new opportunities to save the US biosimilar market and generate profit.

Number 2: The Center for Biosimilars® provided an updated look on the adalimumab biosimilars that are 

 as well as what stakeholders need to know and how they can prepare ahead of the US launch of 8 adalimumab biosimilars in July 2023.

Here are the top 5 biosimilar articles for the week of July 3, 2023.



The Top 5 Biosimilar Articles for the Week of July 3

The US biosimilar market gains 2 additional adalimumab products: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp).

Both Idacio and Hulio reference Humira (adalimumab), one of the most profitable drugs in the world. Throughout July 2023, 

 are projected to launch in the United States.

The launches of these 2 products come after 5 adalimumab biosimilars entered the US market over the Fourth of July weekend. 

, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Coherus Biosciences’ Yusimry (adalimumab-aqvh), Organon and Samsung Bioepis' Hadlima (adalimumab-bwwd), and Sandoz' Hyrimoz (adalimumab-adaz) launched. 

, Celltrion's Yuflyma (adalimumab-aaty) launched. 

 (adalimumab-atto), developed by Amgen, also launched in January 2023.

Adalimumab products are used to treat a range of rheumatic and immunology diseases.

This is the Idacio adalimumab biosimilar autojector and the box it comes in.

, its first immunology biosimilar. It is a low-concentration, citrate-free product. FDA approval of Idacio was granted in 

, and the biosimilar will be used for 7 of the 11 indications of the reference product, Humira (adalimumab). It will be offered in a self-administered prefilled syringe and a self-administered pre-filled pen (autojector).

“We are thrilled to launch Idacio, our first immunology biosimilar in the U.S.,” said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. “Our adalimumab biosimilar forms part of a dedicated pipeline of affordable and high-quality immunology biosimilars from Fresenius Kabi, aimed to improve the quality of life of patients with chronic diseases,” according to the press release.

The Idacio branded biosimilar is offered in over 35 countries. It is indicated for decreasing signs and symptoms of diseases such as rheumatoid (RA), juvenile idiopathic arthritis, psoriatic arthritis (PsA), ankylosing spondylitis, Crohn disease, adult ulcerative colitis, and plaque psoriasis.

Earlier in 2023, Fresnius Kabi launched its first US biosimilar 

 (pegfilgrastim-fgpk), a pegfilgrastim biosimilar.

Hulio and the Biocon Biologics/Viatris Portfolio Transfer

This is the Hulio adalimumab biosimilar autojector pen.

Hulio is a low-concentration adalimumab product that is citrate-free, allowing for less injection site pain during administration. It does not have an interchangeability designation and the Biocon Biologics has not indicated that it will try to obtain the label.

The biosimilar is available in a prefilled syringe and autoinjector pen. 

"Biocon Biologics is pleased to make Hulio, a patient-friendly, 2-click, prefilled pen available in the United States for patients with certain inflammatory diseases” said Mathew Erick, chief commercial officer of advanced markets at Biocon Biologics, in a

. "There are no buttons to push. Patients remove the cap and push the device against their skin to trigger their injection. Designed and built with patients in mind, healthcare professionals and patients don’t have to miss a beat with Hulio; they simply, ‘Click, Click, Go.'"

The biosimilar was approved in July 2020. Hulio is indicated for RA, PsA, juvenile idopathic arthritis, ankyosing spondylitis, Crohn disease, and ulcerative colitis. 

The wholesale acquisition cost of the branded product is 5% below the current list price for Humira. Biocon Biologics is also offering an unbranded option of the same drug that is priced 85% below Humira's list price, similar to Amgen's 

, the company's patient support program, which offers patients benefits verification and prior authorization support, copay assistance, a bridge program, and at-home nurse injection training.

The biologics license application for the product was submitted by Viatris but is now fully under the control of Biocon Biologics after the later company acquired the former's entire biosimilar portfolio.

Biocon Biologics’ acquisition of Viatris’ biosimilars was announced in 

. As of July 1, Biocon Biologics has completed the integration of the acquired biosimilars business in over 70 countries. 

Viatris and Biocon Biologics have stated continue to work together over the next few years to ensure a smooth transition. As part of the agreement, Viatris will receive up-front payments of $2.3 billion and compulsorily convertible preference shares in Biocon Biologics, which are valued at $1 billion.

"This will allow Biocon Biologics to meaningfully expand the geographic reach of the existing biosimilars portfolio and future pipeline into growth markets where Viatris has existing sales infrastructure and local market expertise," commented Susheel Umesh, chief commercial officer of emerging markets at Biocon Biologics, in a 

. "Working closely with key stakeholders in these markets will allow us to ensure reliable supplies of our biosimilars for those who need them the most, while enabling us to capitalize on the rapidly expanding global biosimilars opportunity."

Abridlada (adalimumab-afzb) by Pfizer is the last biosimilar anticipated to launch in July 2023.

The US gains 2 more adalimumab biosimilars on the market: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp). The launches come after 5 launched over the Fourth of July weekend.

US Welcomes Idacio, Hulio to the Adalimumab Biosimilar Market

Long-term results of a study comparing ranibizumab biosimilar SB11 vs reference ranibizumab (Lucentis; RBZ) on 

neovascular age-related macular degeneration

 (nAMD) show additional support for the biosimilarity ratified between SB11 and RBZ, according to 

This study was conducted to offer longer-term data on the efficacy, safety, immunogenicity, and pharmacokinetics (PKs) o  SB11 compared with RBZ in patients with nAMD, a dominant global cause of visual impairment and blindness in people older than 50 years. Loss of vision can harm vision-related quality of like and is linked to a total annual direct cost of over $575 million. Biosimilar availability might be able to limit the socioeconomic burden of blindness triggered by nAMD.

The patient population consisted of patients age 50 and over with nAMD (n = 705) with 1 “study eye.” The intervention consisted of 1:1 randomization to monthly intravitreal injection of 0.5-mg SB11 or RBZ every 4 weeks from baseline to week 48.

First, a multicentered, randomized, double-masked, parallel-group, phase 3 equivalence study was conducted. Main outcome measures consisted of visual efficacy end points, safety, immunogenicity, and PK up to 52 weeks.

Baseline and disease characteristics were analogous between treatment groups. Of 705 randomized participants (SB11, n = 351; RBZ, n = 354), 634 participants (SB11, n = 307; RBZ, n = 327) fulfilled the study until week 52.

Formerly reported equivalence in primary efficacy stayed stable up to week 52 and was comparable between SB11 and RBZ. The adjusted treatment difference among SB11 and RBZ in the full analysis set at week 52 of change from baseline in best-corrected visual acuity was −0.6 letters (90% CI, −2.1 to 0.9) and of change from baseline in central subfield thickness, −14.9 mcm (95% CI, –25.3 to –4.5).

Between SB11 and RBZ, respectively, the incidence of ocular treatment-emergent adverse events (TEAEs) (32.0% vs 29.7%) and serious ocular TEAEs (2.9% vs 2.3%) seemed comparable between treatment groups, and no new safety concerns were seen. The PK and immunogenicity profiles were analogous, with a 4.2% and 5.5% cumulative incidence of antidrug antibodies, respectively.

The data also showed no clinically meaningful differences between SB11 and RBZ. Primary and secondary efficacy end points remained similar at all timepoints up to week 52, validating comparable longer-term efficacy aligned with the results from previously reported studies with RBZ for nAMD.

In terms of safety, the safety profile of SB11 looks to be true to the known RBZ profile, and no new safety concerns were recognized during the study period.

“TEAEs were mostly mild or moderate in intensity, and the majority of events was not related to the study treatment,” said the researchers.

It’s been observed that biosimilars in other fields of medicine can add to lowering health care costs and better patient access to therapies with approved labels. More research is needed to study the contribution of RBZ biosimilars to decreasing undertreatment in nAMD and advancing the visual outcomes in clinical practice.

To the best of the researchers’ knowledge, this is the first study to convey  phase 3, week 52 follow-up data of ranibizumab biosimilar for nAMD treatment. However, they added that larger studies will be needed to see if small numerical differences found in the cumulative incidence of antidrug antibodies at week 52 that were within the known 1%-to-9% range for RBZ actually represent small immunogenicity result differences.

“In summary, the longer-term results of SB11 support the previously reported efficacy, safety, immunogenicity, and PK compared with RBZ in participants with nAMD, supporting its use as a safe and effective RBZ biosimilar,” concluded the researchers.

Bressler NM, Veith M, Hamouz J, et al. Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes. 

. 2023;107(3):384-391. doi:10.1136/bjophthalmol-2021-319637

Long-term results comparing ranibizumab biosimilar SB11 vs reference ranibizumab (Lucentis) on neovascular age-related macular degeneration (nAMD) support biosimilarity between the treatments.

Biosimilarity Between SB11 and Lucentis for nAMD Further Supported

On this episode, we’re going to be recapping some of the biggest stories in the business space regarding biosimilars, including adalimumab preparation, partnerships for commercialization, and more.

Mark Cuban’s Online Pharmacy Partners With Coherus Biosciences for Humira Biosimilar

Roundup: Coherus Resolves AbbVie Dispute; Bio-Thera Solutions and Celltrion Expand Respective Partnerships

Eye on Pharma: First PBM to Cover Yusimry; Celltrion to Test Ocrevus Biosimilar; Another Stelara Settlement

The Age of Adalimumab Is Upon Us: How Stakeholders Can Prepare

Alvotech, Advanz Pharma Extend Partnership for Biosimilars in Europe

Medicare 340B Program May Be Reducing Biosimilar Uptake

Sandoz Roadmap Aims to Increase Worldwide Biosimilar Adoption by 2030