Biosimilars Month in Review: June 2023

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The biosimilar month in review highlights ranibizumab biosimilars for the treatment of neovascular age-related macular degeneration (nAMD), Optum Rx’s decision to place subcutaneous adalimumab-adbm on its commercial formulary as a preferred brand, and studies evaluating the cost-saving benefits of biosimilars for patients.

Ranibizumab Biosimilar for Treatment of nAMD

nAMD, a common eye disease that can cause blindness, is generally treated with vascular endothelial growth factor (VEGF) inhibitors, such as ranibizumab. However, their high cost and repeated anti-VEGF injections could create an economic burden for payers and limit treatment access. Therefore, access may be improved with the better availability of less expensive biosimilar products.

XSB-001 Shows Equivalent Efficacy to Ranibizumab in nAMD Treatment

The randomized, double-masked, parallel-group XPLORE trial evaluated the efficacy, safety, pharmacokinetics, and immunogenicity of XSB-001 versus reference ranibizumab in 582 patients ≥50 years of age with newly diagnosed, active, subfoveal choroidal neovascularization (CNV) lesion secondary to nAMD in the study eye. Patients were randomized to receive XSB-001 (n = 292) or reference ranibizumab (n = 290).

The analysis suggested the biosimilar candidate demonstrated equivalent efficacy, as assessed by improvement in best-corrected visual acuity (BCVA), at 8 weeks, with a generally safe and well-tolerated safety profile consistent with the reference product.

Review Shows Consistent Efficacy Between Ranibizumab Biosimilar, Reference Product

A total of 16,712 studies underwent title and abstract screening, with 30 of these undergoing full-text screening to assess eligibility. Of these 30 studies, 5 studies reporting on 4 randomized controlled trials with a total of 1544 eyes at baseline were included in the systematic review and meta-analysis.

No significant differences were observed between reference ranibizumab and any ranibizumab biosimilar included in the study for visual and anatomical outcomes. There were also no obvious differences in measures of retinal thickness (central subfield thickness [CST] or central macular thickness [CMT]) or change in BCVA between treatment groups.

“Our findings were consistent with previously published retrospective studies and reviews and further expand on the bioequivalence of the 4 studied ranibizumab biosimilars,” wrote the investigative team, led by Netan Choudhry, MD, from Vitreous Retina Macula Specialists of Toronto.

Biosimilar Adalimumab-abdm Receives Preferred Status

On July 1, 2023, 5 adalimumab biosimilars, adalimumab-abdm (Cyltezo), adalimumab-adaz (Hyrimoz), adalimumab-aqvh (Yusimry), adalimumab-bwwd (Hadlima), and adalimumab-fkjp (Hulio), were officially made available to patients in the United States (US).

Prior to its official launch, the Cyltezo injection pen received preferred formulary status with Optum Rx, a subsidiary of UnitedHealth Group, which covers more than 66 million commercial insured members. The decision to add the pen to its formulary could benefit millions of Americans, improving access to the medicine. The addition of these treatments will allow patients to have more treatment options at potentially cost-saving prices.

Adalimumab-adbm Receives Preferred Formulary Status With Optum Rx

Optum Rx placed the biosimilar injection on its commercial formulary as a preferred brand, according to a statement from Boehringer Ingelheim. The drug, a US Food and Drug Administration (FDA)-approved interchangeable biosimilar to adalimumab (Humira), was initially approved in 2017 for the treatment of a variety of chronic inflammatory conditions.

Adalimumab-adbm is subcutaneously administered via a pre-filled Cyltezo Pen, which was FDA-approved in May 2023 ahead of its July launch date. It received an “Ease of Use” demarcation by The Arthritis Foundation, which recognizes devices that make everyday tasks easier for patients living with arthritis. The pen features a 1-button, 3-step activation with a protected needle and 100% drug visibility.

Cost-Effective Possibility of Biosimilars

A common reason for prescribing biosimilars is the cost-saving potential for patients. Included in this month's top stories, investigators explored the cost-effectiveness of disease-modifying antirheumatic drug (DMARD) biosimilars in combination with methotrexate, as well as the retention rates of various biosimilars in treating patients with psoriasis.

Cost-Effectiveness and Patient Benefit Balance of Methotrexate, DMARD Combination Therapy

In a cohort of Thai patients, combination methotrexate plus biologic DMARDs (bDMARDs), biosimilar DMARDs (bsDMARDs), and targeted synthetic DMARDs (tsDMARDs) provided .009 to .33 quality-adjusted life years gained with additional costs of 550,986 to 2,095,744 Thai baht (THB) (USD $15,957 to $60,722) when compared with standard of care. The incremental cost-effectiveness ratios (ICERs) ranged from 2.3 to 8.1 million THB per quality-adjusted life years (US $65,935 to $234,996) compared with the standard of care.

Ultimately, none of the combinations were deemed cost-effective. Results were sensitive to the mortality hazard ratio of patients exhibiting high disease activity.

Idacio Biosimilar Shows Higher Retention Rates and Comparable Cost-Effectiveness in Psoriasis Treatment

In a recent study assessing the cost per responder of adalimumab biosimilars as compared with methotrexate for psoriasis treatment, data indicated MSB11022 (Idacio) showed higher retention rates than both ABP 501 (Amgevita) and methotrexate at week 24 and week 52.

The results showed at week 52, retention rates were 81% for Amgevita, 82% for Idacio, and 63% for methotrexate. Based on the reported retention rates, adalimumab biosimilars provided superior treatment persistence among patients with moderate-to-severe psoriasis.

Analysis Suggests Cost-Effectiveness of Ranibizumab Biosimilar for nAMD Treatment

A ranibizumab biosimilar may be the most cost-effective treatment option compared with other available anti-VEGF therapies by both treat-and-extend (TAE) and pro re nata (PRN) regimens for patients with nAMD, according to a group of Japanese investigators.

In comparison with best supportive care, although best supportive care did not incur drug and administration costs, the higher societal costs due to daily care for best supportive care led to a lower total cost for ranibizumab biosimilar TAE. Similar to other TAE regimens, the ranibizumab biosimilar was considered cost-saving compared with ranibizumab PRN and was dominant to best supportive care in PRN regimens.

Results were considered robust, regardless of whether clinical data were taken from the direct head-to-head clinical trial or from in-direct treatment comparison, according to investigators.