Anticipating and retiring inherent risks in biosimilar development

The global uptake of parenteral biosimilars has been rapidly increasing, leading to an estimated compound annual growth rate of 15% through 2030.1

A key driver for biosimilar volume growth has been the expected loss of protection for originator brands which account for more than $100B in global sales.2

As a result, the market is becoming increasingly competitive putting first-to-market entrants at an advantage. It is critical for pharmaceutical companies to prevent challenges from occuring early in development.



See how BD can help de-risk combination product development for generics and biosimilars

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Case Study 1
De-risking FDA Abbreviated New Drug Application (ANDA) submissions with the BD Vystra™ Disposable Pen for Liraglutide

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Case Study 2
De-risking FDA Abbreviated New Drug Application (ANDA) submissions with the BD Vystra™ Disposable Pen for Semaglutide

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Case Study 3
De-risking FDA Abbreviated New Drug Application (ANDA) submissions with the BD Physioject™ Disposable Autoinjector for Tirzepatide

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360° rotation knob is effectively sized, contoured and located to enable easy instrument rotation.

360° rotation knob is effectively sized

360° rotation knob is effectively sized

360° rotation knob is effectively sized

More product details

BD Physioject™ Disposable Autoinjector

Clinically validated, patient accepted10,11

With more than 120 million BD Physioject™ Disposable auotoinjectors sold12, BD has been helping patients manage their chronic illnesses for over a decade13. BD offers customization options to enable pharmaceutical companies to adapt the BD Physioject™ platform to align with their individual brand strategies.

The BD Physioject™ Disposable Autoinjector can accomodate various filling volumes & concentrations with no design adjustments necessary to help reduce development time14. With a patient centric design, the BD Physioject™ Disposable Autoinjector offers pharmaceutical companies a multitude of benefits.

• Button mechanism to prevent accidental activation15,16* 
• 100% drug visibility through a 360º degree window15,17 
• Automatic needle insertion17 
• Cap design to prevent re-capping once the device has been opened15


*30 samples have been tested through bench tests and no devices were pre-activated under the target range button locking force

Download the brochure

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Commercially proven BD solutions accompanied by regulatory, technical, and medical expertise can help you de-risk your biosimilar combination product development.
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*This was a single session, simulated study with 55 participants wherein each patient performed 5 simulated injections with BD Vystra™ Disposable Pen and different testing doses. Ergonomic features include a dose set knob permitting
to set and correct the dose. A 1 to 5 likert scale was used to evaluate setting up and correcting the required dose. 92% of patients indicated it was easy or very easy to set the dose while 91% indicated it was easy or very easy to correct the dose

References
1. “Biosimilars to continue rapid growth over the next decade”, IQVIA; January 3, 2022 https://www.iqvia.com/blogs/2021/12/biosimilars-to-continue-rapid-growth-over-the-next-decade
2. “Spotlight on biosimilars” - IQVIA, June 24, 2021 https://www.iqvia.com/insights/the-iqvia-institute/reports/spotlight-on-biosimilars
3. Hopkins BP, Miller KJ. Swimming upstream: developing and commercializing diabetes products in a patent protected world. J Diabetes Sci Technol. 2013;7(2):302‐307. Published 2013 Mar 1. doi:10.1177/193229681300700203.
4. Van den Bemt BJF, Gettings L, Domańska B, Bruggraber R, Mountian I, Kristensen LE. A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience. Drug Deliv. 2019;26(1):384‐392. doi:10.1080/10717544.2019.1587043
5. Li Z, Easton R. Practical considerations in clinical strategy to support the development of injectable drug-device combination products for biologics. MAbs. 2018;10(1):18-33. doi:10.1080/19420862.2017.1392424
6. Pourkavoos, N. Unique Risks, Benefits, and Challenges of Developing Drug-Drug Combination Products in a Pharmaceutical Industrial Setting. comb.prod.ther. 2, 2 (2012). https://doi.org/10.1007/s13556-012-0002-2
7. ISO-11608 requirements for needle injection systems. https://www.iso.org/obp/ui/#iso:std:iso:11608:-1:ed-3:v1:en
8. Blackstone EA, Joseph PF. The economics of biosimilars. Am Health Drug Benefits. 2013;6(8):469‐478.
9. “Challenges with System Integration” [external study], Franklin Lakes, NJ, USA: GLG 2019 Double blinded qualitative market research with 8 industry experts. Participants worked directly on drug development projects, requiring combination devices (primary and secondary containers) and included the assembly of PFS and/or PFS with
autoinjectors.
10. Berteau, Cecile, et al. “Evaluation of performance, safety, subject acceptance, and compliance of a disposable autoinjector for subcutaneous injections in healthy volunteers.” Patient Preference and Adherence. 2010:4 379-388
11. Schwarzenbach, Florence, et al. “Results of a human factors experiment of the usability and patient acceptance of a new autoinjector in patients with rheumatoid arthritis.” Patient Preference and Adherence. 2014:8 199-209
12. BD WW Demand Database, March 2023
13. Press Release: October, 2010
14. REF-43005 – BD Physioject™ customer website
15. Physioject™ design input specification [internal report]. Pont-de-Claix, FR: Becton, Dickinson and company; 2014
16. Physioject™ external R&D document. Design Control Evidence of BD Physioject™ with Hypak™ for BTH 1mL Long Size [external report]. Pont-de-Claix, FR: Becton, Dickinson and company; 2021
17. Physioject™ design verification report [internal report]. Pont-de-Claix, FR: Becton, Dickinson and company; 2014
18. BD Vystra Design Verification Executive Summary Report
19. A simulated study of acceptance, preference and willingness to adopt of a new pen injector (BD Vystra™) [Internal study], Pont-de-Claix, FR: Becton Dickinson and Company; 2014
20. Pen injector patents:C-2003
21. BD Vystra Freedom to operate (FTO) Drug Delivery System Patent Clearance - 2018
22. Study summary of the Validation of BD UltraSafe Plus™ Passive Needle Guard 2.25ML: PHS-18-SSI09 ES rev1, April 2020
23. PHS-21-SSI18; Summative evaluation report for usability of the BD UltraSafe Plus™ Passive Needle Guard 1mlL
24. Customized Executive Summary_ BD UltraSafe Plus™ Passive Needle Guard 2.25 mL [Internal study]. Pont de Claix, FR: Becton Dickinson and Company; 2019 (PHS-18-SSI09)
25. Quality Statement - ISO 23908 for BD UltraSafe Plus™ 1mlL Passive Needle Guard
26. Quality Statement - ISO 23908 for BD UltraSafe Plus™ 2.25mlL Passive Needle Guard