Patients in the U.S. are already confronted by the world’s longest climb to affordable biosimilar medicines. NAFTA 2.0 (USMCA) will eliminate easier routes and keeps drug prices out of reach for American patients.
The U.S.-Mexico-Canada Agreement (USMCA), the update to the North America Free Trade Agreement (NAFTA), contains provisions that will:
WASHINGTON, DC (March 7, 2019) – “AAM is reviewing the FDA’s new draft guidance on biosimilar naming requirements and will submit comments to the docket. FDA’s current requirement of suffixes presents a significant, artificial barrier to biosimilars that is misaligned with the agency’s own Biosimilars Action Plan and the Trump administration’s commitment to lowering drug prices for America’s patients.”
Biologic drugs are pushing the boundaries of medicine, and their potential to benefit patients with unmet medical needs has never been more promising. For example, researchers are using a viral therapy to treat advanced melanoma by targeting only cancerous cells, and prompting the patient’s immune system to attack them as well.
The U.S. Food and Drug Administration (FDA) plays a critical role in keeping Americans healthy. When it comes to drug approvals, the FDA’s scientists and regulators strive every day to keep pace with the most current advances in science so that patients can benefit from innovative, safe, and effective medicines.
Christine Simmon, AAM Senior Vice President of Policy and Strategic Alliances and Executive Director of the Biosimilars Council, invites industry professionals to attend GRx+Biosims 2018 on Sept. 5-7 in Baltimore, MD. This year, we are combining FallTech, Leading on Biosimilars, and CMC Workshop to one can't-miss opportunity to connect with peers around the world.
Christine Simmon, Executive Director of AAM's Biosimilars Council, reacts to the recent release of FDA's Biosimilars Action Plan
Agency’s Commitment to Competition, Efficient Development and Approval Process Lauded
Administration’s Plan Embraces Getting More Generic and Biosimilar Medicines to Patients
WASHINGTON DC (May 11, 2018) – In President Trump’s remarks today at the White House, he made clear the essential role that generic and biosimilar medicines play in containing prescription drug costs for patients.