Biosimilars

The Time is Right for Canada to Incorporate a Naming Convention for Biologics and Biosimilars into its Emerging ePrescribing Infrastructure

By Pooja Babbrah, Senior Consultant In January 2017, the Food and Drug Administration (FDA) released the Final Rule for Biosimilar Naming. In this final rule, the FDA spelled out the …

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 …

Biosimilar Recommendation Means Challenges and Opportunities Ahead for HealthIT

By Tony Schueth, CEO & Managing Partner Biosimilars now are set to hit the US market with the recent recommendation that the government approve Novartis’s Zarxio cancer drug as a …