On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019. When
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Amneal Completes Acquisition of Kashiv
On August 10, 2026, Amneal Pharmaceuticals, Inc. completed its acquisition of Kashiv BioSciences, LLC. According to Amneal, the acquisition results in “a fully integrated global biosimilars leader with end-to-end capabilities across research, development, manufacturing and commercialization,” and “establishes one of
Division of Corporation Finance Provides Update on Shareholder Proposal Process
On August 14, 2026, the SEC’s Division of Corporation Finance announced that it would discontinue responding to Rule 14a-8 no-action requests entirely, including those submitted under Rule 14a-8(i)(1), unless and until the Division announces otherwise. The Division also indicates that
Fresenius Kabi and Dr. Reddy’s Announce FDA Approval of Rituximab Biosimilar
On August 1, 2026, Fresenius Kabi and Dr. Reddy’s Laboratories announced that the FDA had approved Dr. Reddy’s rituximab biosimilar, a biosimilar to Genentech’s RITUXAN® (rituximab). Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes
FDA Issues Its First Freeze-Dried Plasma License
On July 29, 2026, the FDA announced that it had licensed EZPLAZ FDP, the first freeze-dried (lyophilized) plasma product to be licensed in the United States. The license was issued to Vascular Solutions LLC, a subsidiary of Teleflex Incorporated.
Genentech Files BPCIA Patent Infringement Suit Against Biocon Over Proposed PERJETA Biosimilar
On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to
FDA Approves Meitheal Pharmaceuticals’ Insulin Aspart Biosimilar GARZULYS
On July 30, 2026, Meitheal Pharmaceuticals, Inc. (“Meitheal”) announced that the U.S. Food and Drug Administration (“FDA”) has approved GARZULYS (insulin apsart-fsan) injection. GARZULYS, a biosimilar to Novo Nordisk’s NOVOLOG® (insulin aspart), is a rapid-acting insulin analog indicated to improve
Celltrion Targets European Secukinumab Market with EMA Filing for CT-P55
Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (“EMA”) for CT-P55, its biosimilar to Novartis’ COSENTYX® (secukinumab). The application covers all indications held by COSENTYX® in Europe, including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic
Public Company Advisory News Roundup: SEC Division Issues Order Approving Nasdaq’s New $5 Million Market Value Continued Listing Requirement; Order Subsequently Stayed
The latest issue of the Goodwin Public Company Advisory News Roundup has been posted, covering the period from July 20, 2026 – July 30, 2026. The Roundup highlights the latest developments in SEC and stock exchange regulatory activity, corporate governance
Accord BioPharma Launches OSVYRTI® and JUBEREQ® Denosumab Biosimilars
On July 23, 2026, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., announced the commercial launch of OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), FDA-approved interchangeable biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. OSVYRTI® is indicated for the treatment