Berlex suit v. Biogen Avonex dismissed: small change in adverse effects can prove clinical superiority.
Executive Summary
BERLEX SUIT AGAINST BIOGEN AVONEX APPROVAL DISMISSED by D.C. federal court Judge James Robertson on Oct. 7. "FDA did not act unlawfully when it: determined that Avonex is `clinically superior' to [Berlex'] Betaseron; approved Avonex for use by patients with [multiple sclerosis] without requiring clinical trials of Avonex; and issued its comparability guidance document without notice-and-comment rulemaking," the judge ruled.