The SEC’s Investor Advisory Committee will hold a public meeting on March 12, 2026, at 10:00 a.m. ET at the SEC’s headquarters in Washington, D.C. The meeting will also be webcast on the SEC’s website. The published agenda includes three
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SEC Chairman Atkins on AI: Strategy, Governance, and the Discipline of Principles
On March 4, 2026, SEC Chairman Paul S. Atkins delivered remarks at the Financial Stability Oversight Council’s Artificial Intelligence Innovation Series Roundtable on Strategy and Governance Principles, outlining how the Commission is approaching artificial intelligence as both a regulatory tool
FDA Accepts Dr. Reddy’s Laboratories’ BLA for Abatacept Biosimilar
Dr. Reddy’s Laboratories (“Dr. Reddy’s”) announced on February 22 that the FDA accepted its BLA for DRL_AB, a proposed interchangeable biosimilar to Bristol-Myers Squibb’s ORENCIA® (abatacept) IV for infusion. According to the press release, abatacept works as a selective co-stimulation
Janssen Files BPCIA Complaint Against Bio-Thera and Accord Related to Golimumab Biosimilar
Public Company Advisory News Roundup: SEC Chairman Atkins Speaks on Steps SEC is Taking to Encourage IPOs
The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from February 13, 2026 – February 27, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance and
Genentech Brings Pertuzumab Biosimilar Fight to the ITC
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods
European Biosimilar Updates
On February 13, 2026, STADA and Bio-Thera announced that they have received European Marketing Authorization for GOTENFIA®, a golimumab biosimilar to Johnson & Johnson’s SIMPONI®. GOTENFIA® is a human monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), a key driver
SEC Chairman Atkins Reinforces Focus on IPOs and Capital Formation
In remarks delivered on February 23, 2026 at the U.S. Chamber of Commerce Center for Capital Markets Competitiveness, SEC Chairman Paul S. Atkins reinforced his ongoing agenda aimed at revitalizing U.S. public markets and reversing the long-term decline in the
FDA Approves Accord’s FILKRI (filgrastim-laha), a Biosimilar to NEUPOGEN
On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha), a biosimilar to Amgen’s NEUPOGEN (filgrastim). FILKRI was developed by Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals Ltd.
FILKRI is indicated for patients with
New Oral Polio Vaccine Type 2 (nOPV2) Prequalified by WHO
On February 10, 2026, the World Health Organization (“WHO”) prequalified a new novel oral polio vaccine type 2 (“nOPV2”) product. The newly prequalified product will be manufactured by Biological E. Limited, India using in-house bulk vaccine technology transferred from PT