New guidance from Health Canada on the submission requirements for obtaining approval for biosimilar biologic drugs (biosimilars) has recently been reviewed by stakeholders submitting feedback prior to Health Canada’s Sept. 8 deadline.
Among those submitting advice to the federal regulatory authority responsible for drug approval in Canada, the Canadian Life & Health Insurance Association (CLHIA) has written to express its support for Health Canada’s move to prioritize quality assessments over clinical trials when reviewing biosimilar drugs for introduction in Canada.
“This shift could accelerate market access for biosimilars, reduce costs and align Canada with international standards,” they write. “This approach is already in place in the United States and European Union. Continuing the status quo of requiring Canadian clinical trials will serve to place Canada off-side with evolving best practices as well as being less attractive as a market to new biosimilars.”
CLHIA’s recommendations
Among the CLHIA’s recommendations, they also suggest rethinking the need for new drug submission processes under a different brand name when seeking eligibility for indications for which the originator drug was not approved. “We would question the need for this where new indications are minor or expansions to existing criteria,” they write.
The guidance applies “to all biologic drug submissions where the sponsor seeks authorization for sale based on a demonstrated high degree of similarity to a previously authorized biologic drug and relies on prior information regarding that biologic drug to support, in part, a reduced clinical package as part of the submission,” the draft guidance states.
The CLHIA’s submission says the revised approach using post-market monitoring mechanisms and quality assessments over clinical trials “will benefit Canadians and the reimbursement landscape by bringing biosimilars to the market more quickly, reducing the cost of this effort,” they write, adding that the move will also incentivize more drug makers to seek approval for their biosimilars in Canada.
