Tagged as: Alvotech

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

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA.  The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval.  As part…

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Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA

On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. SIMLANDI injection was approved for nine indications—rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurative, and uveitis. The approval follows…

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

On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab).  The settlements cover Canada, the European Economic Area, and Japan, clearing the way for Alvotech to launch AVT04 in those markets, where AVT04 has already received regulatory approval. …

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Alvotech and STADA obtain approval in Europe for ustekinumab biosimilar, UZPRUVO

On January 10, Alvotech announced that the European Commission (EC) issued a marketing authorization to its European commercialization partner, STADA, for UZPRUVO (AVT04), a biosimilar referencing STELARA (ustekinumab). The authorization covers all European Economic Area countries, as well as Iceland, Liechtenstein, and Norway. UZPRUVO is the first ustekinumab biosimilar to…

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Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

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…

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European Biologics Regulatory Updates

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending aflibercept 8 mg for approval for extended treatment intervals in two major retinal…

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Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable Adalimumab Biosimilar

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.  As…

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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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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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