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FDA Extends Wait for Biosimilar Interchangeability Guidance
The United States Food and Drug Administration (FDA) was expected to release interchangeability guidance on biosimilars sometime…
FDA Releases Draft Guidance for Industry on Biosimilar Interchangeability
On January 17, 2017, the Food and Drug Administration (FDA) released a draft guidance intended to assist sponsors in demonstrating…
The Uncertain Future of Biosimilars in the United States
Friends of Cancer Research held an event, “The Future of the U.S. Biosimilars Market: Development, Education, and Utilization,” on…
Alliance for Health Reform Holds Biosimilar Panel
The Alliance for Health Reform recently held a briefing on biologic drugs and the emerging market for biosimilar…
FDA Announces Information Collection Regarding Biosimilar Suffixes
The Food and Drug Administration (FDA) has announced an information collection seeking sponsors of past and present…
FDA: Biosimilars Labeling Guidance
After several delays the FDA has finally released its draft guidance that says a biosimilar's label does not have to be…
Update on Biosimilars US Regulation 1st Quarter 2016
Yesterday the FDA approved Inflectra the Pfizer/Celltrion version of Remicade, becoming the second biosimilar and the…
FDA Offering Free Biosimilars CME Course
There is a ballooning interest in biosimilars and interchangeable products in the pharmaceutical industry, especially…
BioSimilars: FDA Panel Overwhelming Recommends Approval of Remicade…
Yesterday an FDA Advisory panel overwhelmingly recommended the Celltrion/Pfizer biosimilar Remsima 21-3 for approval for…
Biosimilars Clinical Studies and Analytical Similarity Summit – Update on…
This year, Pharma IQ, a division of the International Quality and Productivity Center, will be hosting the Biosimilars…