Generic Line

Biosimilars makers must dole out nearly $2 million in fees for applications requiring clinical data in fiscal 2013, while companies submitting applications without such data, or supplemental apps, will need to fork over half that amount.

Generic drugs have saved the U.S. more than $1 trillion over the past decade, a figure that well exceeds predictions from when the Hatch-Waxman Act was enacted in 1984, according to a new study.

Generic preemption issues may again wind up before the Supreme Court as generic maker Mutual Pharmaceutical is calling on it to reverse an appeals court decision that upheld a $21 million jury award to a patient injured by Mutual’s sulindac.

GPhA’s plan to help the FDA deal with drug shortages should launch in the coming weeks, after the FTC found it will not be anticompetitive as sensitive information will be protected.

Amid lingering quality issues at a number of its manufacturing plants, Hospira reported some success in its discussions with the FDA but notes there are more trouble spots than the company previously thought.

Companies blazing a path in the biosimilars arena likely have a long wait before their products can achieve an interchangeability designation, as the FDA admits to slow progress on that standard.

A 2–1 final federal appeals court decision that lifts an injunction barring Watson Pharmaceuticals and Amphastar from selling a generic version of Sanofi’s blockbuster blood-thinner Lovenox hinged on an expansive interpretation of Hatch-Waxman’s “safe harbor” provision — a move that could have wide-ranging implications for all patent holders, warns Momenta Pharmaceuticals, which lost its appeal.