In June 2017, the US Supreme Court ruled that the “patent dance” was not mandatory for biosimilar manufacturers. Since then, our discussion of the patent dance (not patent litigation) has been infrequent. The first wave of biosimilars tended to perform the dance (or did it not incompletely). Therefore, manufacturers of drugs like filgrastim, infliximab, epoetin, … Continue reading Dancing With the Stars, Patent Style
Tag: Patent Dance
US Supreme Court Strikes Down 180-Day Waiting Period
In a unanimous decision, the Supreme Court rejected Amgen’s oral arguments—a biosimilar manufacturer can meet the 180-day notification period requirement by notifying the originator’s manufacturer before receiving approval. In other words, biosimilar launches can occur immediately after approval by the Food and Drug Administration (FDA).
No Clear Winner on Supreme Court’s Biosimilar Hearing Day
Despite the fact that the arguments at Wednesday's Supreme Court wrestling match on the patent dance and 180-day notification issue went into overtime, there was no clear winner discernable in Amgen v. Sandoz.
Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018
Call it irritation, exasperation, or frustration, but biosimilar manufacturers and payers alike are feeling it, as the fight over drug patents has barred the way to approval for yet another biosimilar for a costly biologic. In this case, Sandoz’s Erelzi™, which was approved by the Food and Drug Administration on August 30, 2016, has been … Continue reading Frustration Mounts as Sandoz’s Etanercept Biosimilar Launch Delayed into 2018