Topic: Biologics

Doing Business in China: Latest Need-to-Know from JD Supra

For your convenience, here’s a roundup of recent legal commentary and analysis on a broad range of issues facing companies doing business in and with China, on data privacy and protection, merger control regulations, employment law, intellectual property, corruption, and more: Chinese Ministry of Industry and Information Technology Issues Draft Provisions Governing Protection of Personal… 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 »