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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Sarah Beth S. Kuyers ordered by Published Date Descending.
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45 States Now Have Biosimilar Substitution Laws
Forty-five states and Puerto Rico have now enacted laws that permit or require pharmacists to dispense an interchangeable biological product in certain situations.
United States
18 Feb 2019
2
Some BPCIA Clouds Begin To Clear: FDA Issues Final Plans For March 2020 "Deemed To Be A License" Provision
In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces of policy news affecting the nascent biosimilar market.
United States
2 Jan 2019
3
Changes Ahead For HIPAA?
As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda.
United States
6 Nov 2018
4
President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway For Regenerative Medicine
The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises.
United States
21 Dec 2016
5
FDA Approves Third Biosimilar Product
As we predicted in yesterday's post, FDA approved a new biosimilar product, Sandoz's Erelzi (etanercept-szzs), which is a biosimilar to Amgen's Enbrel (etanercept), on August 30th.
United States
6 Sep 2016
6
Biosimilar FDA Approvals On The Horizon As More States Enact Substitution Laws
Shortly after we published this blog post, FDA approved Sandoz's biosimilar to Amgen's Enbrel (etanercept), called Erelzi (etanercept-szzs).
United States
5 Sep 2016
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