Health Canada has posted a draft guidance for the approval of biogenerics, which it has termed subsequent entry biologics (SEBs). According to the government agency's guidelines, manufacturers can include a slimmed-down clinical package in their submission as long as they can show similarity between their product and a previously approved biologic, even one not approved in Canada. Manufacturers can rely in part on publicly available information, but must show—through side-by-side comparisons—that the quality, safety and efficacy of the SEB is comparable to those of the original biologic. Andrew Storey, vice president of Cangene, a biopharmaceutical company based in Winnipeg, Manitoba, welcomed the guidance but has reservations. “You want doctors to be able to prescribe it like a generic drug, but [Health Canada] is suggesting that additional studies will be required. That's not the case for generic drugs and that shouldn't be the case for [subsequent entry] biologics.” Health Canada will convene a stakeholder consultation in early June. In the US, California has recently introduced a bill that paves the way for biogenerics legislation. 'The Pathway for Biosimilars Act' proposes a minimum of 12 years' exclusivity, plus another2 years for a medically significant innovation. The European Agency for the Evaluation of Medicinal Agents has already implemented a regulatory pathway for 'biosimilars' and is reviewing a raft of new products.