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

JD Supra Law

The parties announced in a press release that their settlement and license agreement allows Biocon to commercialize Bmab 1200, its proposed biosimilar to Stelara® (ustekinumab), in the U.S. by February 2025, subject to FDA approval. By: Venable LLP

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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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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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Time to look Beyond Compulsory Licenses? A Glimpse at the Ribociclib Case

SpicyIP

Image from here Recently, the Print reported that Novartis and Eli Lilly have voiced their opposition to the idea of compulsory licensing (“ CL ”) for breast cancer medications, Ribociclib and Abemaciclib. It also says that no licenses were given out. – The Indian Council of Medical Research Report 2020 provided that 100.5

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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. Amgen secured a U.S. The post Biocon Settles with Janssen, Securing U.S.

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

LexBlog IP

In February 2023, Formycon announced its entry into a global license agreement with Fresenius Kabi to commercialize FYB202 in key global markets after successful regulatory approvals. According to the press release, Formycon plans to submit a biologics license application later in 2023 to seek regulatory approval for FBY202.

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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. Alvotech and Teva Pharmaceuticals, Inc.