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Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Goodwin

Updates on Aflibercept BPCIA Litigation - January 2024

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On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the...more

Goodwin

Regeneron’s Disputes with Celltrion, Samsung Bioepis, and Formcycon on Service and Personal Jurisdiction in Aflibercept BPCIA...

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As we have previously reported, in November 2023 Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed complaints against Celltrion,  Samsung Bioepis and Formycon (collectively, “the Defendants”) in the U.S. District Court for...more

Goodwin

Aflibercept IPR Updates - July 2023

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​​​​​​​On July 19 and 20, 2023, the PTAB granted institution of IPR2023-00442, filed by Samsung Bioepis regarding Regeneron’s Patent No. 10,130,681 which is directed to treating angiogenic eye disorders with alibercept, and...more

Goodwin

Biosimilar Market Updates: Samsung Biologics, Celltrion, and Alvotech

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Samsung Biologics’ third quarter report disclosed that it had suspended its research and development of its SAIT101, a biosimilar of Rituxan. As we previously reported, the rituximab product was being developed through...more

Goodwin

Biosimilar Market Updates

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During the first weeks of 2019 a number of biosimilar developers announced updates regarding their plans for the future. Bio-Thera Solutions Partners with Cipla for Bevacizumab Biosimilar Candidate - On January 14,...more

Goodwin

Biosimilar Development Updates: Infliximab, Ranibizumab, Etanercept, Filgrastim & Trastuzumab

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According to a May 7, 2017 record on ClinicalTrials.gov, Celltrion is conducting a Phase 1/3 clinical trial to evaluate efficacy and safety between a subcutaneous biosimilar of infliximab (“CT-P13 SC”) with its currently...more

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