Tagged as: Stelara

FDA Approves Amgen's WEZLANA As Biosimilar to and Interchangeable With Janssen's STELARA (ustekinumab) - Stelara Is One of the 10 Drugs Selected by CMS for Drug Price Negotiations Under the Inflation Reduction Act

On Tuesday, October 31, FDA approved Amgen’s WEZLANA (ustekinumab-auub) as biosimilar to and interchangeable with Janssen’s STELARA (ustekinumab).  WEZLANA is the first product to be approved as a biosimilar to STELARA.  As we covered previously, Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023….

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Update on Recent International Biosimilar Approvals

Approval of Fresenius Kabi’s Tocilizumab Biosimilar in the EU:  On September 19, 2023, Fresenius Kabi announced that the European Commission (EC) granted marketing authorization for TYENNE (tocilizumab), a biosimilar referencing Roche’s ROACTEMRA.  TYENNE is the first tocilizumab biosimilar approved in the EU.  TYENNE received approval for both subcutaneous (prefilled syringe…

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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…

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BREAKING NEWS - HHS Announces the First 10 Drugs Selected for IRA Drug Price Negotiation Program

HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…

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

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.  In February 2023, Formycon announced its entry into a global license agreement with Fresenius…

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Teva and Alvotech Expand Strategic Biosimilars Partnership

Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S.  According to the announcement, the existing agreement includes AVT02, an interchangeable high-concentration biosimilar candidate for HUMIRA (adalimumab), and four other biosimilar candidates, including AVT04, a proposed biosimilar of STELARA (ustekinumab).  The…

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EMA Accepts MAA for Dong-A ST’s Ustekinumab Biosimilar

On July 14, Dong-A ST announced that the European Medicines Agency accepted its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar referencing STELARA (ustekinumab).  STELARA is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The MAA submission was based on the results of a…

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Samsung Bioepis Files Four IPR Petitions on Alexion Eculizumab Patents and One IPR Petition on a Janssen Ustekinumab Patent

Samsung recently filed the following IPR petitions challenging all claims of four patents assigned to Alexion relating to SOLIRIS (eculizumab): IPR2023-00998, challenging claims 1-3 of U.S. Patent No. 9,718,880; IPR2023-00999, challenging claims 1-10 of U.S. Patent No. 9,725,504; IPR2023-01069, challenging claims 1-8 of U.S. Patent No. 10,590,189; and IPR2023-01070, challenging…

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Celltrion and Rani Therapeutics to Jointly Develop Oral Formulation of Adalimumab Biosimilar

Celltrion and US-based Rani Therapeutics (“Rani”) announced that they entered an agreement to develop RT-105, an orally administered adalimumab biosimilar made using the RANIPILL platform.  The announcement explains that RANIPILL capsules are Rani’s payload agnostic oral delivery technology intended to replace subcutaneous or intravenous injection of biologics or drugs, and…

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

gloved hand withdraws drug solution with syringe

Alvotech and Teva Pharmaceuticals, Inc. 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.  “According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than…

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