Posted by Michael Wonder on 11 Jun 2017
Subsequent entry products for non-biological complex drugs
9 June 2017 - In order to reflect the current environment for subsequent entry non-biological complex drugs, CADTH, in consultation with CDR-participating drug plans, has determined that these products are eligible for review through the CDR process.
Submissions for subsequent entry non-biological complex drugs will undergo a tailored CDR review. CADTH currently follows a tailored review process for all CDR submissions involving new combination products (funded components) and for biosimilars. Submissions for subsequent entry non-biological complex products may be filed on a pre-NOC or post-NOC basis using the current processes described in section 2.2 of the Procedure for the CADTH Common Drug Review (August 2014).
A subsequent entry non-biological complex drug is a medicinal product that demonstrates a high degree of similarity to an already authorized product (i.e., a reference product that has been approved for use in Canada). Due to the complex nature of the product, demonstrating bioequivalence may not be possible.
