Sandoz Launches First U.S. Biosimilar
Client Alert | 2 min read | 09.04.15
On Thursday, Sandoz launched the first U.S. biosimilar after the Federal Circuit's Amgen v. Sandoz decision on Wednesday to deny Amgen's request to extend the injunction that had prevented the launch. The injunction barring launch was set to expire and Amgen moved to extend the stay while the full Federal Circuit considers Amgen's petition for en banc review of its July 21 ruling that would allow the launch. The motion was denied without comment, in a 2-1 split decision. See Order.
This represents the latest development in an ongoing litigation over the first biosimilar to gain approval in the U.S. Sandoz had filed an abbreviated biologics license application (aBLA) with the FDA. Once the application was accepted, Sandoz notified Amgen of its intention to launch once it gained approval. Sandoz also refused to provide its aBLA and manufacturing information to Amgen by the end of the statutory deadline. On this basis, Amgen filed suit in the Northern District of California. There, the court held that (i) disclosure of a biosimilar applicant's Biologic License Application (BLA) and proprietary manufacturing information to the reference product sponsor is permissive; and (2) that a biosimilar applicant is required to give the reference sponsor 180-day notice of the first commercial marketing of the biosimilar only after the biosimilar is approved by the FDA. See our previous Client Alert: "District Court's Decision Paves the Way for the First U.S. Biosimilar."
As we previously reported, the Federal Circuit had held that Sandoz did not violate the Biologics Price Competition and Innovation Act (BPCIA) by not disclosing its aBLA and the manufacturing information by the statutory deadline. Amgen petitioned the full Federal Circuit to revisit that interpretation of the BPCIA and moved to continue the injunction preventing Sandoz's launch pending that determination.
Amgen's petition for en banc review is still pending.
Contacts
Insights
Client Alert | 5 min read | 06.11.25
Steel Tariffs Doubled: How the Hike Could Reshape Construction Projects at Home and Abroad
To date the Trump Administration has issued multiple proclamations imposing varying rates of import duties on steel and aluminum and certain derivatives, including construction materials. These measures have added volatility and financial pressures to the construction sector both in the United States and abroad. Most recently, on June 3, 2025, President Donald Trump issued a proclamation under Section 232 of the Trade Expansion Act of 1962, doubling tariffs on imported steel and aluminum from 25% to 50%, effective June 4, 2025. This action aims to counteract the continued influx of lower-priced, excess steel and aluminum imports that, according to the administration, threaten U.S. national security by undermining domestic production capacity. The proclamation notes that while prior tariffs provided some price support, they were insufficient to achieve the necessary capacity utilization rates for sustained industry health and defense readiness. The United Kingdom remains temporarily exempt at the 25% rate until July 9, per the U.S.-U.K. Economic Prosperity Deal.
Client Alert | 5 min read | 06.11.25
The FCPA Pause Is Over: Trump DOJ Issues Long-Awaited FCPA Investigations and Enforcement Guidelines
Client Alert | 4 min read | 06.10.25
Trump Administration Cyber Executive Order Revises Prior Administrations’ Requirements
Client Alert | 19 min read | 06.09.25
