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July 8, 2016
On Tuesday, July 5th the Federal Circuit Court announced the final decision in the case of Amgen v. Apotex, ruling that manufacturers of biosimilar products must notify their brand-name competitors...
May 4, 2016
Additional information on FDA's draft guidance is available in our preceding FDA News article, entitled "FDA Guidelines for Post-Approval CMC Changes, Part One: Overview of the Updated Draft...
May 3, 2016
On April 19, 2016, FDA released a revised and updated draft guidance entitled "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information," which...
April 7, 2016
On Tuesday, April 5th, FDA announced the approval of Inflectra™ (infliximab-dyyb), a biosimilar version of Janssen Biotech's Remicade® (infliximab), for a number of indications. Inflectra is...
April 7, 2016
According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009. The infographic, entitled “Tracking FDA Drug...
March 31, 2016
On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to...
March 30, 2016
On Monday, March 28th the FDA announced that it is amending its current IND and bioequivalence regulations. Specifically, FDA stated that it is changing “its regulations to update the address for...
February 8, 2016
On February 1, 2016, the Biosimilars Forum, a nonprofit organization dedicated to increasing biosimilar access in the US, announced the launch of “Partnership for Biosimilar Education and Access,” a...
November 5, 2015
On November 3, 2015, Tufts Center for the Study of Drug Development (CSDD) published its November/December Tufts CSDD Impact Report. According to the report, when “first-in-class” drugs receive...