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On June 9, the Office of the Comptroller of the Currency (OCC) responded to a letter from the Conference of State Bank Supervisors (CSBS)...

In March 2025, a Northern District of Texas judge denied the CFPB's 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 BLA submission included results from different studies comparing the structural and functional similarities between HLX02 and reference trastuzumab.

Accord BioPharma has announced the commercial availability of two FDA-approved interchangeable biosimilars to Amgen's PROLIA and XGEVA, marking a significant milestone in the company's ambitious plan to introduce 20 biosimilars to the U.S. market by 2030. These denosumab-based treatments target osteoporosis, bone loss, and skeletal-related events in cancer patients.

On May 24, 2022, Alvotech Holdings S.A. ("Alvotech") announced positive top-line results from a confirmatory clinical trial for AVT04, Alvotech's proposed biosimilar...

Amneal Pharmaceuticals has finalized its acquisition of Kashiv BioSciences for up to $1.1 billion, creating what the company describes as a fully integrated global biosimilars platform. The deal positions Amneal to launch multiple biosimilar products annually and capitalize on an unprecedented wave of biologic patent expirations in the coming years.

On December 1, 2024, Biocon announced that the FDA has approved YESINTEK™ (ustekinumab-kfce), a biosimilar to J&J's STELARA®.

On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab...

This article compiles recent developments in the biosimilar pharmaceutical industry, covering regulatory submissions, market launches, licensing agreements, and legal proceedings across multiple therapeutic areas.

Celltrion and US-based Rani Therapeutics ("Rani") announced that they entered an agreement to develop RT-105, an orally administered adalimumab biosimilar made using the RANIPILL platform.

The FDA has granted interchangeability designation to TRUXIMA® (rituximab-abbs), making it the first rituximab biosimilar to achieve this status in the United States. This milestone allows pharmacists to substitute TRUXIMA® for the reference product RITUXAN® without prescriber intervention, potentially expanding access to this treatment for conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

On April 28, the U.S. District Court for the District of New Jersey denied Janssen Biotech, Inc. ("Janssen") and Johnson & Johnson's motion for a preliminary injunction seeking to enjoin Samsung Bioepis Co. Ltd. ("Samsung") from launching a private label biosimilar of Janssen's STELARA® (ustekinumab) in a breach of contract case.

Dualitas Therapeutics has entered into a research collaboration and license agreement with Roche to advance novel bispecific antibodies for immunology and inflammation diseases using Dualitas' DualScreen Bispecific Discovery Engine. The collaboration will functionally screen over 300,000 novel bispecific combinations to discover therapeutics with synergistic activities unattainable with conventional approaches.

The FDA and SEC have formalized their interagency cooperation through a new memorandum of understanding that enables unprecedented information sharing about FDA-regulated products and companies. This framework allows the SEC to access nonpublic FDA data during public company filing reviews and enforcement investigations, potentially transforming disclosure requirements and compliance strategies for life sciences companies.

On June 7, 2022, from 9:30-10:50 AM Eastern Time, FDA is hosting, virtually, its annual public meeting for public comment on Financial Transparency and Efficiency...

On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson's STELERA® (ustekinumab).

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.