Try for free

Ontario EAP Biosimilar Exemption Request (ON00521E)

This two-page form lets a prescriber request an exemption from Ontario's Biosimilar Switch Policy for an Ontario Drug Benefit patient using an originator (innovator) biologic previously authorized through the Exceptional Access Program. It covers patients who cannot switch to a biosimilar and those asking to switch back after a biosimilar switch. Clinical information must support a temporary or long-term medically necessary exemption.

Who completes it

The prescriber completes all four sections, including the current EAP request number for the originator and the clinical reasons, and signs with a licence number; the patient does not complete any part.

Submitting and payment

How to submit it
Submit through SADIE for faster processing, or fax or mail it to the Exceptional Access Program at the ministry's Delivery and Eligibility Review Branch.

Good to know

  • Reasons include current pregnancy, palliative end-of-life care, needing more time to switch, side effects to two biosimilar versions, pediatric weight-based etanercept dosing, or medical reasons a biosimilar cannot be used.
  • For side effects to two biosimilars, attach completed Health Canada Side Effect forms for each product; they must also be submitted to Health Canada.
  • Do not use this form for patients without an existing EAP approval, such as those new to ODB who were stabilized on an originator through other funding.
  • The ministry notes true allergies to every biosimilar version are rare and asks prescribers to check product monographs for the biosimilar closest to the originator's non-medicinal ingredients.

Get the official form

Download the current version from the source each time; forms change without notice.

Exceptional Access Program (EAP) - Biosimilar Exemption Request

Programme d’Accès Exceptionnel – Formulaire de demande d’exemption pour les produits biosimilaires

Official pagePDFVersion française

Fill it with Vero

Upload the fillable PDF once and Vero Documents fills it from the visit note and the chart, ready for you to review and sign. Download, print, or email the finished form, with the patient’s consent.

See how Vero Documents works

How this list is checked

A form is listed only after its name and number were confirmed on the issuing agency’s or insurer’s own website, or in the form itself. Each entry links to that source. The list was last checked in October 2026. Forms change without notice, so download the current version from the official page before you fill it in.

Vero is not affiliated with, or endorsed by, the agencies and insurers listed here. Read our editorial policy.

Frequently asked questions

When can an Ontario patient be exempted from the biosimilar switch?

The form lists current pregnancy, palliative end-of-life care, needing more time to switch, side effects to two biosimilar versions, pediatric etanercept use with weight-based dosing, medical reasons a biosimilar cannot be used, and other reasons. Each needs supporting details, such as a due date, weight or consult notes.

What if my patient has no EAP approval for the originator biologic?

Then this form does not apply. The ministry says patients without an existing EAP approval, such as those new to ODB who were stabilized on an originator through another funding mechanism, need a full EAP request with complete clinical details, and it suggests SADIE for new requests.

Is the Ontario biosimilar exemption form available in French?

Yes. The ministry's Central Forms Repository offers a French version, ON00521F, alongside the English ON00521E (2023/03). The English version is an XFA e-form, so it fills correctly only in Adobe Acrobat or Reader, not in a web browser.