Topic: Biosimilars

JD Supra Corporate Brief: Iran Sanctions, E-Communications Policies, UK Fracking, Union Elections

Our cure for the Monday morning blues? Two shots of espresso and the JD Supra Corporate Brief… Let’s be clear on this point: Iran is NOT open for business… (Amanda Blunt, Carrie Kroll, and Lindsay Meyer at Venable) More than 80% of business correspondence takes place via email. And that creates a lot of risk… Read more »

JD Supra Corporate Brief: Cyber Insurance, Mary Jo White, CEO Liabilities, Biosimilar Law

Happy Alaska Day! This is why you need cyber insurance… (BakerHostetler) How has Mary Jo White done in her first six months on the job? (Reed Smith) Yes, the CEO could be held liable for unpaid wages… (Baker Donelson) Sure, the shutdown is over, but the questions about paying furloughed contractors remain… (Morrison & Foerster)… Read more »

New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

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 »

Biosimilars Benefit From Health Care Reform Decision

“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 »

FDA Publishes Draft Rules on Biosimilars – Legal Roundup

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 »