Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5. In January 2017, the FDA released a draft guidance on biosimilar…
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017: 5. In January 2017, the FDA released a draft guidance on biosimilar…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five…
As we previously reported, last month a Federal Circuit panel affirmed the district court’s judgment that Apotex’s pegfilgrastim and filgrastim biosimilar candidates do not infringe Amgen’s…
Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s…
As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment…
Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s…
Earlier today, the Federal Circuit Court of Appeals issued its long-awaited decision in the remand of Amgen v. Sandoz from the U.S. Supreme Court. In that decision, the Federal Circuit…
The Federal Circuit today ruled decisively in favor of Sandoz in the long-running battle with Amgen over whether state law can be used to compel a biosimilar applicant to participate…
We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint…
In October, a Federal Circuit panel vacated a permanent injunction (which the Federal Circuit had earlier stayed pending appeal) that would have otherwise prohibited the sale of Sanofi…