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Amgen Files BPCIA Complaints Against Biocon, Shanghai Henlius/Organon and Hikma/Gideon Richter Regarding Denosumab Biosimilars

In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. ...more

FDA Approves Celltrion’s New Pediatric Formulation of STEQEYMA, Expanding Dosing Flexibility

On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection. ...more

PTAB Institutes Eight More IPRs Filed by Merck on Johns Hopkins Pembrolizumab Patents

​​​​​​​In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods...more

Update on Recent International Biosimilar Approvals - September 2024

Approval of Celltrion’s Ustekinumab Biosimilar in the EU:  On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA...more

FDA Issues Draft Guidance on Demonstrating Biosimilar Interchangeability

​​​​​​​Last month, the FDA issued draft guidance, which, if implemented, would remove a requirement for a switching study for demonstrating biosimilar interchangeability....more

MDL Panel Grants Transfer of Aflibercept BPCIA Case

As we previously reported, on January 11, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) moved to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation, and to transfer its case against...more

Year in Review: Top Legal Developments of 2023

​​​​​​​As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of some of the top five legal decisions and...more

Regeneron Sues Samsung Bioepis for Proposed Biosimilar of EYLEA in West Virginia District Court

​​​​​​​Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint on November 22 against Samsung Bioepis Co., Ltd. (“Bioepis”) in the U.S. District Court for the Northern District of West Virginia, alleging infringement...more

Updates on Recent Foreign Approvals and Launches

​​​​​​​On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal...more

Bristol-Myers Squibb Files Patent Infringement Complaint Against AstraZeneca Regarding Anti-PD-L1 Antibody Product

On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of...more

Purple Book Updates - 2023

​​​​​​​FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law enacted in late...more

AbbVie’s Q322 Earnings Call Highlights Oncoming Adalimumab Biosimilar Competition

Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023....more

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