Policy - Page 2

The House Appropriations Committee has called upon CMS to increase access to biosimilars.
Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.
 A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.
Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discussed the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.
 
In response to pharmaceutical supply chain disruptions caused by the coronavirus disease 2019 (COVID-19) pandemic, a panel of experts called for big changes; attention to detail is key to making sure the outcomes are successful.
 
Following in the footsteps of British Columbia, other Canadian provinces are working to implement their own biosimilars initiatives that would switch patients from some of the most costly reference biologics to biosimilar counterparts.
Ted Mathias and Stacie Ropka, PhD, both patent attorneys and partners at Axinn, Veltrop and Harkrider LLP, discuss patent exclusivity for biological drugs and other important issues that need to be addressed whether or not the ACA and the Biologics Price Competition and Innovation Act (BPCIA) are ruled invalid.
Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.
Amid the coronavirus disease 2019 (COVID-19) pandemic, the FDA issued guidance stressing the importance that manufacturers notify it of discontinuations and manufacturing interruptions so that the agency can implement contingency measures.
 
Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.
 

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