In March 2025, a Northern District of Texas judge denied the Consumer Financial Protection Bureau’s (CFPB) motion to stay its case against Comerica Bank for alleged mismanagement of a government benefit card program in Consumer Financial Protection Bureau v. Comerica Bank.
The CFPB filed this suit in December 2024, alleging that Comerica provided deficient customer
Arman Oruc, Andy Lacy, Sarah Jordan, and Stephen Mavroghenis are excited to invite you to join Goodwin for an in-person, engaging discussion on antitrust in life sciences transactions, navigating global merger control investigations and what to do when your deal hits a regulatory brick wall. We’ll cover the latest trends in early-stage
On March 3, 2025, Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars referencing Amgen’s PROLIA® and XGEVA®. According to Amneal, the FDA has set a target action date in Q4 2025. Denosumab is a RANK ligand (RANKL) inhibitor that is used to treat bone loss.
As previously reported
With 10 years of litigation since the first BPCIA complaint on NEUPOGEN (filgrastim) was filed in 2014, trends are becoming apparent that should cause all biopharma companies to reassess how they protect biologics and plan for biosimilar launch.
Webinar Highlights:
On March 7, 2025, the District Court for the District of New Jersey entered a Stipulation and Order of Dismissal Without Prejudice in view of a settlement agreement between Amgen and Fresenius Kabi resolving the BPCIA litigation regarding Fresenius’s denosumab biosimilar, FKS518. The Order followed a stipulation by the parties filed on March 4, 2025.
On December 11, 2024, the United States Court of Appeals for the Fifth Circuit vacated the Securities and Exchange Commission’s order related to the rule that required companies listed on Nasdaq to include a board diversity matrix in their proxy filing or on their website. Despite the Nasdaq board diversity matrix no longer being required
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from launching CT-P42, its aflibercept biosimilar of EYLEA®.
As we have previously reported, the Federal Circuit recently affirmed a similar preliminary
On February 28, Amgen, Inc. (“Amgen”) filed three petitions for inter partes review, challenging the validity of all claims in three patents assigned to Bristol-Myers Squibb Co. (“BMS”). The claims of all three patents are directed to methods of treating cancer with the combination of two checkpoint inhibitor immunotherapeutic antibodies, anti-PD-1 and anti-CTLA-4.
IPR2025-00601 challenges
On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; 70 mg/mL injection), referencing Amgen’s PROLIA® and XGEVA®, respectively. These approvals make Celltrion the third company to receive FDA approval for a denosumab biosimilar, joining Samsung and Sandoz.
Denosumab is a RANK ligand (RANKL) inhibitor that
Inventions made in a particular country are generally first-filed in that country before entering the United States via a direct Paris Convention filing or, more commonly, a PCT national stage entry. Convenience, national pride, and foreign filing license laws encourage such home country first-filings.
It is well known that the U.S. biosimilar market has developed
