The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK]
FDA
-
-
In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.FDA approves...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
Many factors contribute to the price that consumers pay for prescription drugs and biologics. These factors include research and...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK] -
The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for...
http://twitter.com/share?text="[TITLE]&url=[PERMALINK]