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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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Celltrion Stelara (Ustekinumab) Settlement With J&J

JD Supra Law

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. By: Goodwin

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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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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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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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Alvotech Announces More Settlements and Expected Launch Dates Regarding Biosimilar to STELARA (ustekinumab), AVT04

LexBlog IP

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). Per the settlement agreement, AVT04 can be marketed in the U.S., subject to regulatory approval, no later than February 21, 2025.

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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.