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Stelara® Biosimilar Updates: Settlement of IPR and FDA Review of Proposed Biosimilar

JD Supra Law

On March 4, 2024, the PTAB granted Biocon and Janssen’s joint motion to terminate IPR2023-01444 due to a settlement reached prior to an institution decision. by February 2025, subject to FDA approval. By: Venable LLP

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Alvotech and Teva Reach Ustekinumab (STELARA) Settlement with J&J

LexBlog IP

announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States. The post Alvotech and Teva Reach Ustekinumab (STELARA) Settlement with J&J appeared first on Big Molecule Watch.

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Formycon/Fresenius Kabi and Samsung Bioepis Settlements with J&J and Janssen Biotech regarding Ustekinumab

LexBlog IP

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J. Economic terms of the settlement were not disclosed in the press release.

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Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

JD Supra Law

Samsung Bioepis recently reported that it has signed a settlement and license agreement with Johnson & Johnson (“J&J”) in the United States relating to SB17, Samsung Bioepis’s ustekinumab biosimilar to J&J’s STELARA®. If SB17 is approved by the FDA, the license period in the United States will begin on February 22, 2025.

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Celltrion Stelara (Ustekinumab) Settlement With J&J

LexBlog IP

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.

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Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

LexBlog IP

The post Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation appeared first on Big Molecule Watch.

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Biocon Settles with Janssen, Securing U.S. Market Entry Date for Ustekinumab Biosimilar

LexBlog IP

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. 10,961,307, which claims methods of treating ulcerative colitis with ustekinumab. Amgen secured a U.S.