Let's have a conversation >

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 20301. 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 sales2.

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.

Contact us

These challenges can cause delays, which then lead to increased costs that can negatively impact profitability3 and decrease the overall viability of the project.

These challeges can icons

Commercially proven BD solutions accompanied by regulatory, technical, and medical expertise can help you de-risk your biosimilar combination product development

Have a conversation
with our BD Expert

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 360-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



BD Vystra™ Disposable Pen


Preconfigured to help reduce uncertainty and risk

Approved in combination products in more than 35 countries18, the BD Vystra™ Disposable Pen is designed for use with a wide range of self injection medications that require variable dosing.

It features a light compact design19, audible clicks, and ergonomic functionality*20 to support patient usage. BD offers numerous benefits to pharmaceutical companies in order to help reduce development costs and shorten lead time.

  • 13 preconfigured offerings for targeted formulations
  • Strong intellectual property protection21
  • Thorough Freedom to Operate analysis conducted22
  • Compatible with standard 3.0ml cartridges and meets ISO standard 11608-2 for pen needle compatability19

* 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 and while 91% indicated it was easy or very easy to correct the dose


BD UltraSafe Plus™ Passive Needle Guard


Manual injection systems providing patient confidence against needle stick injury23

BD offers pharmaceutical companies an ergonomic24, manual injection solution to support the self-administration of biologics with the BD UltraSafe Plus™ Passive Needle Guard. Approved in 28+ combination products, BD has sold more than 150 million12 BD UltraSafe Plus™ Passive Needle Guard devices making it a commercially established solution for biosimilars.

The BD UltraSafe Plus™ Passive Needle Guard is usable by patients, caregivers, and health care professionals25 and offers a multitude of benefits including:

  • User verified ease of use24
  • Optional add-on finger flange for additional injection comfort24
  • Wide variety of plunger rod and add-on finger flange colors to support brand recognition
  • Supports viscous drug delivery25
  • Meets sharps injury protection requirements26,27*
  • Available in both 1ml and 2.25ml formats

* ISO 23908 Sharps Injury Protection and FDA guidance on Sharps Injury Prevention Features



Develop. De-risk. Deliver.

BD Pharmaceutical Services and Solutions are designed to help you achieve your biosimilar combination product goals, from development to launch.



BD PartnerPath

BD PartnerPath™ Program

Gain streamlined access to preconfigured BD products sets and supporting documentation

Device combination product design verification testing

Device combination product design verification testing

De-risk your drug combination product solution through GMP laboratory testing






Drug combination product incoming & batch release testing

Drug combination product incoming & batch release testing

Get support to manage incoming inspection of raw materials but also to manage lot release of your drug combination products

BD YourPath

BD YourPath™ Program

Begin your combination product journey on the right track for your project






BD Custom manufacturing samples

BD Custom manufacturing samples

Support design space verification with silicon level tests at the limits

BD release methods

BD release methods

A “peace of mind” method for incoming inspection and complaint management






Small-scale fill/finish & assembly

Small-scale fill/finish & assembly

Access to GMP environment production for not-for-human-use test quantities

BD Human factor engineering

BD Human factor engineering

Generate the required deliverables compliant with applicable guidelines to support successful registration of your combination product






BD Regulatory support services

BD Regulatory support services

Get support to manage incoming inspection of raw materials but also to manage lot release of your drug combination products

Primary container & device selection and evaluation

Primary container & device selection and evaluation

De-risk the decision making of your primary container system through benchmarking and early-stage container & device studies

Product complaint management & root cause investigation

Product complaint management & root cause investigation

Develop a robust and rapid clinical and/or commercial complaint handling process




Learn More

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Habitant morbi tristique senectus et netus et malesuada fames. Bibendum est ultricies integer quis auctor elit sed.

  • Lorem ipsum dolor sit amet,
  • consectetur adipiscing elit, sed do eiusmod
  • Habitant morbi tristique senectus et netus et
  • Lorem ipsum dolor sit amet,
  • consectetur adipiscing elit, sed do eiusmod
  • Habitant morbi tristique senectus et netus et

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Habitant morbi tristique senectus et netus et malesuada fames. Bibendum est ultricies integer quis auctor elit sed.

  • Lorem ipsum dolor sit amet,
  • consectetur adipiscing elit, sed do eiusmod
  • Habitant morbi tristique senectus et netus et
  • Lorem ipsum dolor sit amet,
  • consectetur adipiscing elit, sed do eiusmod
  • Habitant morbi tristique senectus et netus et

Let’s have a conversation

Contact us | unsubscribe | My profile


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 Regulatory Affairs internal document REF-
19. BD Vystra Design Verification Executive Summary Report
20. 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
21. Pen injector patents:C-2003
22. BD Vystra Freedom to operate (FTO) Drug Delivery System Patent Clearance - 2018
23. Study summary of the Validation of BD UltraSafe Plus™ Passive Needle Guard 2.25ML: PHS-18-SSI09 ES rev1, April 2020
24. PHS-21-SSI18; Summative evaluation report for usability of the BD UltraSafe PlusTM Passive Needle Guard 1mlL
25. 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)
26. Quality Statement - ISO 23908 for BD UltraSafe Plus™ 1mlL Passive Needle Guard
27. Quality Statement - ISO 23908 for BD UltraSafe Plus™ 2.25mlL Passive Needle Guard