Key learning points for physicians, pharmacists and patients.
Following very active discussion of the issues noted above, the roundtable arrived at consensus on a number of critical points likely to define the continuing discussion about Health Canada’s guidelines for regulation of SEBs as noted below.
1) Subsequent entry biologics, or biosimilars or follow-on biologics, are not generic replacements. They should be viewed as stand alone products; the model for regulatory approval of small molecule generic products should not apply to them. Agreement should be reached on a single name to describe these products and the preferred nomenclature from this roundtable would be subsequent entry biologics (SEBs).
2) SEBs should not be considered pharmaceutically or therapeutically equivalent to preceding products and mandatory substitution should not be recommended.
3) SEBs should not normally be deemed interchangeable; however, if a physician and an informed, consenting patient agree to interchange products, they should do so with full understanding of potential health risks and legal liabilities.
4) SEBs cannot be safely or effectively managed by non-physicians through automatic substitution.
5) Canada should follow the EMEA process with respect to SEBs. With suitable adaptation following expert review, the EMEA policies and practices could become the standard for Canadian regulatory practice.
6) Systems should be developed for proactive risk management, post market surveillance, and pharmacovigilance studies relevant to SEBs.
7) Science, industry, and regulatory approaches are evolving with respect to SEBs. The academic community needs to evolve a recognized subspecialization in product and patient safety relevant to these issues.
8) Given that specialized human resources in these fields are scarce, a more targeted approach to patient safety is needed. With respect to SEBs, immunogenicity would be an appropriate primary target.
9) There is a need for at least one international centre of expertise to be established independent from government and industry, and capable of developing and using appropriate criteria and statistical methods to support the conduct of long term comparability studies among SEBs.
10) From a Canadian perspective it should be recognized that there are numerous remaining issues to be addressed with respect to SEBs, including pharmacoeconomics and outcomes research, reimbursement policies, intellectual property protection, patent life, data protection, and market exclusivity policies. There are an equal number of unresolved medicolegal questions.