Biologics and the law

This article is part of our coverage of the Benefits Canada 2011 Face-to-Face: Drug Plan Management Forum, held at the Fairmont Royal York Hotel in Toronto on Dec. 1, 2011. Read more coverage of the event here.

Biologic drugs are much larger than the small synthetic molecules used to treat most conditions. “I can synthesize a small ingredient in a test tube and rest assured it’s the same as the original,” said Lesley Rapaport, president of LRR Patent Law Office in Toronto, speaking at the Face-to-Face Drug Plan Management Forum. With biologic drugs, “there’s a cell doing the work, so you can’t ensure exact duplication”—which is why the copycat biologics in current development will be called follow-on or subsequent-entry biologics (SEBs) rather than generics.

While Canadian drug innovators have to follow an arduous process when filing for regulatory approval for traditional small molecules, generic manufacturers “don’t have to prove as much, so the process is abbreviated—although they have to wait until the patents for the original drug and a data-exclusivity period have expired,” Rapaport explained.

Because SEBs “may differ more substantially from the original than small molecules do,” Rapaport said it is unclear exactly how much information SEB manufacturers will be required to provide. In 2010, the Canadian government issued guidance documents to help address the following questions: What safety and efficacy data will SEB manufacturers have to show? What differences from the original will be sufficient to justify data exclusivity?

An audience member asked whether these regulatory uncertainties, coupled with high manufacturing costs, might deter pharmaceutical companies from the SEB category. “While there may still be a question mark in terms of profitability,” said Rapaport, “several companies have taken an interest in pursuing this market. Stay tuned.”

Gabrielle Bauer is a freelance writer in Toronto. gbauer@sympatico.ca

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