Tag: Biosimilars
How Stakeholders are Affected by FDA’s New Naming Convention for Biologics and Biosimilars
By Pooja Babbrah, Senior Consultant Stakeholders across the industry are debating potential costs and burden associated with implementing the new, nonproprietary naming convention for biologics and biosimilars. Requirements for the …
FDA Issues Guidance on Naming Conventions and Interchangeability for Biologics and Biosimilars
By Pooja Babbrah, Senior Consultant The Food and Drug Administration (FDA) recently issued two new rules that significantly affect biologics and biosimilars. The first rule spells out the naming conventions …
NCPDP Action Group Focused on Biologics and Biosimilars
By Brian Bamberger, Practice Lead, Life Sciences Biologics and biosimilars are starting to burst into the American market. Biosimilars are expected to quickly become mainstream in the near future because …
Biosimilar Legislative Trend Means Big Changes for EHRs
By Connie Sinclair, Director, Regulatory Resource Center Biosimilars are starting to enter the market in the United States and are generating interest because of their significant cost-savings potential and patient …
Biosimilars 101: Considerations for Health IT and Other Stakeholders
By Tony Schueth Biosimilars now are being introduced in the United States and are expected to rapidly become lower-cost, mainstream treatments for a range of chronic diseases, including cancer, rheumatoid …
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