Tagged as: Celltrion

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 of 37 patents under the BPCIA based on Bioepis’s submission of an aBLA for SB15, a proposed biosimilar of EYLEA…

Read More

Regeneron Sues Celltrion For Proposed Biosimilar of Eylea in West Virginia District Court

Regeneron filed a Complaint on November 8 against Celltrion in the U.S. District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of…

Read More

Celltrion Expands Access to YUFLYMA (adalimumab-aaty)

On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA) model that has been effectively displacing traditional PBM’s.”  According to the press release, YUFLYMA (adalimumab-aaty) will be a…

Read More

Recent Adalimumab Biosimilar Developments

FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was…

Read More

PTAB Issues Final Written Decisions Finding Claims of Tocilizumab-related Patents Invalid

On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc.  The ’264 patent claims are directed to…

Read More

Celltrion Stelara (Ustekinumab) Settlement With J&J

It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA. This settlement…

Read More

Samsung Bioepis Files IPR Petition Challenging Regeneron Aflibercept Patent

On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”).  According to the petition, the ’992 patent claims “encompass a formulation comprising the VEGF inhibitor protein,…

Read More

Regeneron Moves to Terminate Celltrion IPR on Aflibercept Patent After Regeneron Files Statutory Disclaimer

Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron’s U.S. Patent No. 10,406,226 which is generally directed to methods of manufacturing VEG-F antagonists, including aflibercept.  Regeneron’s motion to terminate is based on Regeneron’s filing…

Read More