For combination products delivered by autoinjector or prefilled pen, demonstrating safe and effective use in real-world conditions has become an increasingly prominent regulatory expectation. Unlike simulated-use human factors studies conducted in controlled laboratory settings, real-life handling, home-use, and actual-use studies capture genuine patient and caregiver behavior with the drug-device combination under conditions that reflect clinical practice—making them a meaningful component of submissions reviewed by FDA and EMA alike. Regulatory and clinical affairs teams seeking to design or benchmark these studies benefit from understanding what has already been accepted as sufficient evidence in recent approval packages.
This analysis reviews FDA multidisciplinary, clinical, and human factors review documents available through Drugs@FDA, alongside EMA European Public Assessment Reports, for autoinjector and prefilled pen combination products with decisions issued between July 2020 and July 2026. It identifies studies that qualify as real-life, home-use, or actual-use in the regulatory sense—meaning participants administered drug product rather than using a placebo trainer in a simulated environment—and documents how those studies were described, scoped, and evaluated by agency reviewers.
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Real-life handling, home-use, and actual-use studies cited for autoinjectors and prefilled pens (2020 to 2026)
What counts as an "actual-use" study here
Regulators distinguish two things that both get filed in the human factors module:
- Simulated-use HF validation studies (the norm): trained or untrained lay users perform tasks with placebo/trainer devices in a usability lab or a room dressed to look like a home. These validate the user interface and instructions for use (IFU); they are simulations, not real administration.
- Real-life / actual-use / home-use handling studies (what this article catalogs): patients or caregivers administer the actual product, frequently including at least one unsupervised dose at home, and the sponsor measures real-world injection success, use/device errors, and user experience.
The list below prioritizes the second category. A separate section notes the simulated-home HF validation studies that surfaced, because reviewers often cite them alongside actual-use data.
Real-life / actual-use / home-use handling studies cited (2020 to 2026)
| Product (INN) | Sponsor / MAH | Device | Study | What it assessed |
|---|---|---|---|---|
| Nucala (mepolizumab) | GlaxoSmithKline | Autoinjector | Real-World Use Study 204959 16 | Open-label, single-arm, multi-dose, 12-week study in patients >12 yr with severe eosinophilic asthma; correct real-world self- or caregiver administration of 100 mg SC, doses at Week 0 and 8 observed in clinic and Week 4 at home 1676 |
| Benlysta (belimumab) | GlaxoSmithKline | Autoinjector | Study 200339 "real-life use of autoinjector device" 81 | Open-label, single-arm SLE study (n=95) after switching IV to SC; suitability for self-administration, injection failures (use/device errors), safety and trough concentrations, home use after initial observed doses 8182 |
| Repatha (evolocumab) | Amgen | Autoinjector / pen | Home-use studies 20120348 and 20120356 85; Study 20120123 90 | Phase 3 home-use studies of effective administration by patients or caregivers at home using the SC presentations; competency demonstration required before self-administration, first dose supervised 8590 |
| Amgevita (ABP 501, adalimumab) | Amgen | Autoinjector | Real-life subject handling 1 | Single-arm repeated-dose real-life handling; successful self-injection by adults, caregivers, and adolescents after training; use errors and full-correct-dose delivery 1 |
| Hukyndra (adalimumab) | STADA Arzneimittel | Autoinjector | Real-life subject handling in RA 4 | Single-arm repeated-dose study, 107 subjects self-injected after training in moderate-to-severe RA; recorded successful self-injection and found no handling events (a separate simulated HF summative study was also run) 4 |
| Semglee (MYL-1501D, insulin glargine) | Biosimilar Collaborations Ireland (Viatris/Biocon) | Prefilled pen | Non-dosing user handling assessment 2 | Users simulated an injection into a surrogate with the commercial pen (no dose delivered) to test whether patients, caregivers, and HCPs could use it safely/effectively and to capture use errors 2 |
| Skyrizi (risankizumab-rzaa) | AbbVie | Autoinjector; On-Body Injector (OBI) | Real-Life (Patient) Handling Study, "RLHS" 64; Study M16-000 Sub-study 4 (OBI) 150 | Autoinjector RLHS in psoriasis patients using the to-be-marketed device 64; OBI RLHS (Study M16-000 Sub-study 4) in Crohn's disease to confirm safe/effective self-administration and generalizability to real-world performance, application approved 2022 150115 |
| Simponi (golimumab) | Janssen-Cilag | Prefilled pen (VarioJect) / prefilled syringe | Paediatric at-home usability sub-study 79 | Usability sub-study in paediatric participants/caregivers who chose at-home administration; whether the PFS-U and PFP-V with training and IFU were suitable for home use, with questionnaire data showing successful, easy-to-very-easy handling 79 |
| Teriparatide prefilled pen | Apotex (cites Dore RK et al.) | Prefilled pen | Patient-experience clinical trial 34 | Eight-week, single-arm, multicenter, open-label trial; men and postmenopausal women at high fracture risk (current users n=92, non-current users n=107) self-injected 20 mcg/day with the new device; assessed acceptability, complaints, device preference, and usability features 34 |
Notable individual studies
Nucala (mepolizumab), autoinjector, EMA. GSK's Real-World Use Study 204959 is the clearest example of an actual-use design: a 12-week, open-label, single-arm study in severe eosinophilic asthma (>12 years) with a deliberately mixed observation setting, the first and third injections observed in clinic and the second self-administered at home 1676. The program also captured device reliability (100 returned autoinjectors inspected, no substantiated failures) 75, first-attempt injection success across labels 76, and exit interviews in a subset of 25 subjects who reported reduced anxiety and found self-injection easy and convenient 74. A separate simulated HF validation study supported the prefilled pen presentation 80.
Benlysta (belimumab), autoinjector, EMA. Study 200339 is explicitly described as a "real-life use of autoinjector device" study in SLE patients previously on belimumab (n=95), with home use after the initial observed doses and endpoints covering injection failures, safety, and post-switch trough concentrations 8182.
Repatha (evolocumab), EMA. Amgen filed dedicated home-use studies (20120348 and 20120356) assessing effective administration by patients or caregivers at home using the SC presentations, plus Study 20120123 in which competency had to be demonstrated before self-administration and the first self-administered dose was supervised 8590.
Skyrizi (risankizumab), FDA. AbbVie's dossiers reference a "real-life patient handling study (RLHS)" for the marketed autoinjector in psoriasis 64 and, separately, a Real-Life Handling Study for the On-Body Injector with prefilled cartridge (Study M16-000, Sub-study 4) in Crohn's disease, framed as confirming safe/effective self-administration and its generalizability to real-world performance 150115. Participant counts were not stated in the pages retrieved.
Adalimumab biosimilars (Amgevita, Hukyndra), EMA. Both dossiers include "real-life subject handling" of the autoinjector in a single-arm repeated-dose setting, with Hukyndra reporting 107 self-injecting subjects and no handling events 14. These sit alongside conventional simulated HF summative studies.
Adjacent evidence: simulated-home human factors validation studies
These are not real-life/actual-use studies, but reviewers cite them for the same handling questions and several were run in a "simulated home environment," so they are worth flagging for completeness:
- Wainua (eplontersen), autoinjector, FDA — HF validation in a simulated home-use environment with injection-naive ATTR amyloidosis patients and lay caregivers 95.
- Simlandi (adalimumab-ryvk), autoinjector, FDA — comparative use human factors (CUHF) study; Humira Pen-experienced RA patients (n=13) used the AVT02 autoinjector in a simulated home environment without training, to show non-inferior injection success 6558.
- Mounjaro (tirzepatide), autoinjector, FDA — HF validation plus a supplemental HF study; reviewer focus on disposal-related use errors 6263105107.
- Idacio (adalimumab-aacf), autoinjector, FDA — simulated HF study for the autoinjector plus a requested PK bridge between PFS and autoinjector 7071.
- Zegalogue (dasiglucagon), autoinjector, FDA — HF validation study 6168.
- Adbry (tralokinumab), prefilled pen, FDA — HF validation with naive/experienced adults and caregivers 97100103.
- Omvoh (mirikizumab), pen, FDA — HF validation; disposal use errors and root-cause analysis 98105107.
- Enspryng (satralizumab), prefilled syringe, FDA — HF validation summarizing observed errors and close calls 102.
- Naloxone HCl autoinjector (kaleo), FDA — HF validation with buddy- and self-administration scenarios 111.
- Praluent (alirocumab), prefilled pen, EMA — supplemental HF validation extending the pen to adolescents and paediatric HeFH, with home-environment scenarios 8315.
- Saphnelo (anifrolumab), autoinjector, EMA — formative and summative HF studies in SLE/RA/OA, evaluating lay-user home-use performance 18.
- Lonquex (lipegfilgrastim), prefilled syringe, EMA — HF validation in adults and lay caregivers, with planned adolescent HF work 9.
- Wegovy (semaglutide), single-dose pen-injector, FDA — the clinical-study pen was described as intended for home or hospital use and was compared to the to-be-marketed pen; the retrieved pages describe device comparability and HF analysis rather than a discrete real-world handling study 121122127.
Limitations and scope notes
- Coverage is limited to what Drugs@FDA review documents and EMA EPARs disclose. Sponsors do not always publish participant counts or full designs for handling studies, so several entries above (notably the Skyrizi RLHS) lack sample sizes in the pages retrieved 64150.
- The FDA search returned more than 50 candidate pages for two of the broader queries, so this is a representative rather than exhaustive census; additional 2020 to 2026 combination-product filings may cite handling studies not surfaced by these keyword sets.
- The Vocabria (long-acting cabotegravir) record cites only a planned drug-utilization study and PAES (COMBINE 2) as future real-world evidence, not a completed handling study, and is excluded from the main table 156.
- Some records use "real-world use," "real-life handling," and "actual use" loosely; where a study is genuinely simulated (placebo/trainer, lab or dressed-set), it has been placed in the human factors validation section rather than the actual-use table.
- For any single product, the definitive design, endpoints, and participant numbers should be read from the cited FDA review or EMA EPAR page before use in a submission or competitive-intelligence brief.