Stephen Pagnotta Shares Insights on the US FDA Approval of the Cyltezo Pen, a New Autoinjector Option for Cyltezo

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Stephen Pagnotta Shares Insights on the US FDA Approval of the Cyltezo Pen, a New Autoinjector Option for Cyltezo


  • Stephen gave a brief introduction about Cyltezo (an FDA-approved interchangeable Humira biosimilar) and spoke about the features of the Cyltezo Pen (a new autoinjector) approved by the US FDA
  • He also gave a comparative view of the Cyltezo Pen vs. the conventional Cyltezo PFS. He also talked about how BI is informing and educating patients about the Cyltezo Pen
  • The interview shows how BI is advancing to develop novel biologics and interchangeable biosimilars to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide

Smriti: Would you please highlight the details (MOA, ROA, formulations, etc) of Cyltezo.

Stephen Pagnotta: Cyltezo® is approved as a citrate-free low-concentration formulation that is currently available as a 40 mg/0.8 mL, 20 mg/0.4 mL and 10 mg/0.2 mL pre-filled syringe and as a 40 mg/0.8 mL pre-filled autoinjector called the Cyltezo Pen. Cyltezo works by blocking tumor necrosis factor, which is an important regulator of the immune system and is involved in pathogenesis of some autoimmune diseases.

As the first [and only] FDA-approved Interchangeable Humira® biosimilar, patients can expect the same therapeutic effect from Cyltezo as they can from its reference product.

Smriti: Tell us more about the Cyltezo Pen. What are its features and how does it operate?

Stephen Pagnotta: The patient-centered design of the Cyltezo Pen features a one-button, three-step activation, with 100% drug visibility and a protected needle.

The Arthritis Foundation has also certified the Cyltezo Pen as an “Ease of Use” product. For more information about the Arthritis Foundation’s “Ease of Use” certification, please visit their website.

Smriti: How can the injectable Cyltezo Pen provide an alternative to the conventional Cyltezo pre-filled syringe? Give our readers a comparative overview of them both.

Stephen Pagnotta: We recognize that patients living with chronic inflammatory diseases may prefer administering the medication needed to manage their conditions via an autoinjector, and we’re excited to offer this option when Cyltezo becomes commercially available on July 1.

  • A pre-filled syringe is a ready-to-use syringe that comes pre-loaded with a specific medication in a predetermined dose.
  • There are many reasons why a patient may prefer an autoinjector over a pre-filled syringe.
  • Convenience: Auto-injectors are designed to be user-friendly and require minimal steps for administration.
  • Safety and reduced anxiety: Autoinjectors have several safety features that minimize the risk of accidental needlestick injuries. Additionally, the automatic injection process may help reduce anxiety for patients.
  • Accuracy and consistency: Autoinjectors are designed to deliver a precise and consistent dose of medication.

Smriti: The US FDA approved Cyltezo Pen for use in multiple chronic inflammatory diseases. Could you please tell us more about the trial design and the results obtained from the clinical trial based on which Cyltezo Pen was approved?

Stephen Pagnotta: The recent approval of the Cyltezo Pen was supported by Voltaire-AI, which is a study to asses the auto-injector presentation.

The study found that the pharmacokinetics and immunogenicity of Cyltezo delivered via AI were similar to administration using a pre-filled syringe. No differences are expected between the autoinjector and pre-filled syringe use in clinical practice.

Smriti: As you have mentioned the Arthritis Foundation has given Cyltezo Pen the "Ease of Use" certification. Would you please elaborate more on the process and supporting data based on which the certification was granted?

Stephen Pagnotta: For more information about the Arthritis Foundation’s “Ease of Use” certification, please visit their website.

Smriti: Lastly, how do you plan on informing and educating patients about the Cyltezo Pen?

Stephen Pagnotta: As a leading research-driven biopharmaceutical company, we put patients first in everything we do, and we are committed to working with healthcare providers and patients to ensure all stakeholders are familiar with biosimilars.

We have a robust plan for educating patients about the Cyltezo Pen including:

  • An injection education video on Cyltezo.com which provides guidance on administering Cyltezo.
  • A Clinical Education team focused on educating patients on Cyltezo, inclusive of how to administer the medicine.

We also invest in programs and solutions to help ensure our medicines are accessible to the patients who need them. The Cyltezo Patient Support Program through BI Solutions Plus offers a number of resources for eligible patients including one-on-one personalized support.

Image source: Canva

About the Author:

Stephen Pagnotta

Stephen Pagnotta is the Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. In this role, he developed a strategy to introduce Cyltezo to the market while building a fully supportive commercial team by leading various functions to ensure that the brand would be launch-ready in July of 2023.  Stephen earned his Bachelor of Commerce in Marketing from Concordia University in Montreal Canada. He has served as an elected school board president and currently sits as board president of a not-for-profit theater group leading initiatives to provide the arts to underprivileged children.  

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Senior Editor

Senior Editor at PharmaShots. She is curious and very passionate about recent updates and developments in the life sciences industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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