FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Canada Clears Three Drugmakers of Blocking Generic Competitors

Jan. 3, 2019

Canada’s Competition Bureau cleared Celgene, Pfizer and Sanofi of allegedly blocking generic competition, ending a two-year investigation.

The companies were accused of denying samples of their products that would allow potential generic competitors to establish equivalence. In one case, Celgene imposed conditions on the supply of samples through its RevAid risk management program that the generic manufacturer found “unnecessary and burdensome.” But the bureau cleared Celgene because the generic developer was able to secure the samples elsewhere.

The bureau said it found “insufficient evidence to conclude that the elements of the RevAid program that limit distribution to generics are anti-competitive,” adding that the program does not “go beyond legitimate measures to ensure safe use of [its cancer treatment] Revlimid or other regulatory requirements.”

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