America’s health care system is eager for biosimilars, especially in light of mounting evidence that they deliver increased patient access and savings by providing competition for costly brand-name biologics.
Karin Hessler, Assistant General Counsel at the Association for Accessible Medicines, urges attendees to add their voice to the discussion at the one essential generic and biosimilar conference of the year: GRx+Biosims 2019, November 4—6 in Bethesda, MD.
The conference legal track:
I’m Christine Simmon, Senior Vice President of Policy and Executive Director of the Biosimilars Council at the Association for Accessible Medicines.
Working in this sector, I know how it feels to be inundated with invites to conferences and seminars and workshops and webinars -- all of which are supposed to help you stay on top of biosimilars. It’s a lot!
In a letter given to U.S. Trade Representative Robert Lighthizer today, 102 members of the House of Representatives expressed strong concern that the pharmaceutical provisions included in the U.S.-Mexico-Canada Agreement (USMCA) – NAFTA 2.0 – could increase prices for medicines in the United States, while limiting the ability of Congress to lessen pharmaceutical monopoly rights.
As prescription drug costs continue to increase, biosimilar medicines represent hope for patients seeking access to more affordable treatment. Biosimilars are lower-priced versions of brand medicines used to treat debilitating and life-threatening diseases, such as Crohn’s disease, ulcerative colitis, cancer and psoriatic arthritis. Patients and physicians can rely on FDA-approved biosimilar medicines just as they would the brand-name product.
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WASHINGTON, DC (March 7, 2019) – “AAM is reviewing the FDA’s new draft guidance on biosimilar naming requirements and will submit comments to the docket.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.