On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »
“With [the] Supreme Court affirmance of the bulk of the Affordable Care Act, the specter that the BPCIA framework for biosimilar introduction could be dismantled is no longer a concern. Presumably it will be full speed ahead through the regulatory process, and we will see biosimilar applications for approval and attendant patent litigation before too… Read more »
On February 9, The Food and Drug Administration released its draft guidelines for drug makers on the abbreviated approval pathway for biosimilars, a move that could open the door to cheaper generic versions of branded biotech drugs. For your reference, here’s a roundup of legal commentary on the proposed rules: FDA Publishes Draft Guidelines for… Read more »
