YLB113 etanercept biosimilar autoinjector 'safe and effective’

Biosimilares/Investigación | Posted 05/11/2021 post-comment0 Post your comment

Analysis of the YLB113 etanercept autoinjector, a biosimilar to reference etanercept, finds a high rate of injection success and supports the safe and effective use of YLB113 [1].

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YLB113 is an etanercept biosimilar produced by the pharmaceutical companies Mylan and Lupin [2]. It references Enbrel (Pfizer) and can be used in the treatment of a range of inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It works by targeting tumour necrosis factor-alpha (TNF- α), a pro-inflammatory molecule.

Etanercept is administered by subcutaneous injection, however, patients diagnosed with the diseases the drug is indicated for (such as rheumatoid arthritis) may experience difficulties with manual dexterity that hamper their ability to self-administer injections. In such cases, autoinjectors can be useful, offering benefits including improved dose accuracy, ease of use, increased treatment adherence, and reduced injection-site reactions.

YLB113 is one such autoinjector. It delivers etanercept in a single-use, disposable autoinjector, containing 50 mg/mL of etanercept solution. To administer the dose, the user must remove the needle cap and press the autoinjector against the injection site, holding it in place for 15 seconds after the end of the injection.

In a recently published study [1], researchers confirmed that the device can be used safely and effectively by patients. The study included 79 participants representative of etanercept users, including patients, caregivers, and healthcare providers.

Half of the patient and caregiver groups had never used an autoinjector before, while half did have prior experience. Testing was conducted at multiple independent research facilities in the UK, in a simulated home-use environment. Participants received training on the use of the autoinjector according to a training guide one day prior to the usability testing.

On the day of testing, participants were asked to deliver two simulated doses into a foam pad using the autoinjector. At the end of the task, a post-task interview was conducted to investigate any errors and to record the participant’s views of the device.

Results showed that all participants were able to deliver both doses from the YLB113 etanercept autoinjector into the foam pad. Users also answered knowledge questions on various elements of use, such as how to store the device, how to initiate the injection, and how to perform the injection without causing injury. Success rates for the knowledge questions were high, ranging from 88% to 99%. Only 11 use errors occurred on critical tasks over 158 simulated injections. These occurred in most cases (11/12) when removing the pen from the carton and in one case due to stretching of the skin at the injection site.

On the basis of the high injection success rate and high rate of knowledge among users, the authors conclude that the YLB113 etanercept autoinjector can be considered safe and effective as a substitutable biosimilar to Enbrel.

Conflict of interest
Both authors of the research paper [1] are employees and shareholders in Mylan.

Editor’s comment
Readers interested to learn more about etanercept biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Qualitative survey-based evaluation of operability and convenience for the etanercept biosimilar YLB113 in a unique injection pen in patients with rheumatoid arthritis

Etanercept biosimilar has comparable pharmacokinetics to Enbrel

Comparison of brand-name and biosimilar etanercept in Korea

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Long-term safety and efficacy of anti-TNF-α biosimilars in psoriasis

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References
1. Canham K, Newcomb C. Summative usability evaluation of the YLB113 etanercept biosimilar autoinjector via simulation. Generics and Biosimilars Initiative Journal (GaBI Journal). 2021;10(2):61-7. doi:10.5639/gabij.2021.1002.006
2. GaBI Online - Generics and Biosimilars Initiative. Mylan and Lupin make deal for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Nov 5]. Available from: www.gabionline.net/pharma-news/Mylan-and-Lupin-make-deal-for-etanercept-biosimilar

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