Biosimilars are transforming the contemporary pharmaceutical landscape as the need to find affordable treatment options increases. Health Canada has now issued a revised draft guidance to provide Information and Submission Requirements of Biosimilar Biologic Drugs (June 2025). This elaborated framework solidifies the dedication of Canada in regard to scientific precision, patient safety, and innovation.
In Masuu Global, as biopharmaceutical experts, our specialty is in serving biopharmaceutical companies in their intricacy of a biosimilar drug development process, which involves compilation intensities of data to Health Canada submission certification.
What Are Biosimilars?Health Canada describes a biosimilar as a biologic drug, closely similar to one that has already been approved in Canada earlier, which is referred to as the Canadian Reference Biologic Drug (CRBD). Compared to generics, biosimilars are not exact copies since biologics are a complex nature. Rather they require high level of similarity as far as quality, safety and efficacy are concerned.
Key Highlights from the Draft Guidance- Regulatory Framework Biosimilars are governed by and subject to Part C of the Food and Drug Regulations and the Food and Drug Act. The applications should be made under new drug submissions (NDS) instead of using the generic route.
- Data Requirements A biosimilar NDS should comprise of:
- Larges scales of comparative analytical data (physicochemical, functional and stability)
- Selective non-clinical and clinical data emphasizing on pharmacokinetics (PK) and immunogenicity
- Any deviation with the CRBD Justification
- Labeling and Indications The biosimilar sponsors may request to approve all indications as well as the CRBD has. All they require is a high level of similarity to be proved. The product’s biosimilar status must be clearly defined in the product monograph.
- Use of Non-Canadian Reference Biologics Sponsors have the opportunity to utilize non-Canadian sourced reference biologic drugs, pending that bridging studies sufficiently justify that the drug is judged the same as the CRBD.
- Risk Management and Post-Market Surveillance An Effective Risk Management Plan (RMP) is required, which will allow monitoring safety and assessing immunogenicity continuously during the product lifecycle.
The new guidance is intended to make it easier to approve biosimilars without lowering Canada standards. It improves on changing international best practices and promotes early engagement with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) to plan a good submission.
How Masuu Global Supports Biosimilar SuccessMasuu Global is an unmatched, in-depth specialist firm with expertise in worldwide clinical regulatory writing and a successful track record of biosimilar submissions. Our group of experts are making sure that each dossier is fully science-based, regulatory-compliant, and ready to submit.
Our services include:- The preparation and examination of the comparative analytical summaries
- Writing of risk management plans and product monographs
- Submission management of eCTD-compliant documents
- Oversight BRDD consultation and regulatory strategies
Partner with Masuu Global to confidently advance your biosimilar from development to approval.
Contact us today to learn how we can accelerate your regulatory success.