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License Agreements Biosimilars

Goodwin

Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation

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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...more

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Alteogen and Sandoz Enter a Biosimilars Agreement Relating to Subcutaneous Products

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​​​​​​​Alteogen Inc. announced that it entered an exclusive license agreement with Sandoz AG pursuant to which Sandoz will have world-wide rights to use Alteogen’s ALT-B4 hyaluronidase, derived using Hybrozyme™ Technology, to...more

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Biosimilars Licensing Agreement Updates

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Earlier this week, Biocon Biologics Ltd. announced that it has entered into a strategic out-licensing agreement with Yoshindo Inc. to commercialize ustekinumab and denosumab biosimilars for the Japanese market. Pursuant to...more

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Organon and Henlius Entered into a Global License Agreement for Henlius’s PERJETA® (Pertuzumab) and PROLIA®/XGEVA® (Denosumab)

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Organon announced yesterday that it has entered into an agreement with Henlius, whereby Organon will license commercialization rights for biosimilar candidates referencing PERJETA® (pertuzumab) and PROLIA®/XGEVA®...more

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Biocon Biologics Ltd. To Acquire Viatris Biosimilars Portfolio

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On Monday, Biocon Biologics Limited (Biocon) announced that it will acquire Viatris’ rights in biosimilars assets for up to $3.3 billion. Viatris and Biocon previously partnered to bring SEMGLEE to market in the U.S. ...more

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Biogen and Xbrane Enter into Worldwide Commercialization and License Agreement for Certolizumab Pegol Biosimilar

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On February 7, 2022, Biogen Inc. and Xbrane Biopharma AB announced that they had entered into a commercialization and license agreement related to Xcimzane, a certolizumab pegol biosimilar referencing CIMZIA. Under the...more

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Alvotech and BiosanaPharma Enter Exclusive Global Licensing Agreement for AVT23

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Alvotech Holdings S.A. (“Alvotech”) announced that it has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair® (omalizumab). Xolair®...more

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Bio-Thera Solutions and Hikma Pharmaceuticals Enters Into Ustekinumab Biosimilar Agreement

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Last week, Bio-Thera Solutions and Hikma Pharmaceuticals announced they have entered into an exclusive commercialization and license agreement to commercialize the proposed ustekinumab biosimilar product, BAT2206. According...more

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Theramex announces license agreement for Prolia biosimilar in Europe and Australia

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On Thursday Theramex announced that it has entered into an agreement to register and commercialize denosumab, a biosimilar of Enzene Bioscience’s Prolia®, which treats osteoporosis by decreasing bone absorption. The agreement...more

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Recent Biosimilars Deals

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On January 13, 2021, EVOQ announced a license and collaboration agreement with Amgen for the development of new drugs for autoimmune disorders. According to the press release, Amgen and EVOQ will collaborate on preclinical...more

Smart & Biggar

Federal Court orders Minister of Health to issue NOC to Fresenius Kabi for its biosimilar IDACIO following filing of consent...

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On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA: Fresenius Kabi v...more

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Medicure International Enter Agreement with Reliance Life Sciences for Cardiovascular Biosimilar

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Yesterday, Medicure, Inc. announced that its wholly-owned subsidiary, Medicure International Inc., has entered into a license, manufacture and supply agreement with Reliance Life Sciences Private Limited for a cardiovascular...more

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STADA and Xbrane Ink Commercialization Deal with Bausch + Lomb for LUCENTIS Biosimilar Candidate

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On May 6, 2020, Bausch + Lomb and co-development partners STADA and Xbrane announced that they have entered into an exclusive licensing agreement with one another under which Bausch + Lomb will commercialize Xlucane, STADA...more

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Biosimilar Market Updates: Canada, US, China

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Below are some recent developments in the biosimilar industry from around the globe: On January 14, 2020, Alvotech announced that it entered into a partnership with Canada-based JAMP Pharma for the supply and...more

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AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

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Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab. According to the press releases, AbbVie has granted...more

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AbbVie Grants Momenta Global Patent Licenses for Biosimilar of HUMIRA (Adalimumab)

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Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira®...more

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AbbVie Licenses Humira® (Adalimumab) Patents to Mylan

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This morning AbbVie announced that it has entered into patent license agreements with Mylan over its proposed biosimilar of Humira® (adalimumab). AbbVie states that it has agreed to “grant Mylan a non-exclusive license on...more

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Biosimilars Update: Clinical Trials, Marketing Authorization Applications, Licenses, and Launches

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Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710....more

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FDA Approves Ogivri, Mylan’s Biosimilar Version of Herceptin

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Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of...more

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Mylan Obtains Global License to Trastuzumab in IPR Settlement

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Mylan announced today that it had reached a settlement with Genentech, Inc. and F. Hoffman-La Roche Ltd. that provides Mylan with global licenses to commercialize its biosimilar to Genentech’s Herceptin® (trastuzumab). As...more

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LG Life Sciences Begins Phase III Trials for Humira Biosimilar

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LG Life Sciences recently announced the start of phase III clinical trials for its Humira® (adalimumab) biosimilar in South Korea.  The clinical trials will test the effectiveness of the biosimilar on rheumatoid arthritis...more

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Sorrento Announces Successful Trial with Omalizumab Biosimilar

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On May 16, 2016, Sorrento Therapeutics announced successful results from a Phase 2 and 3 clinical study for a biosimilar to Xolair. Xolair (omalizumab) is marketed by Genentech and Novartis to treat allergic asthma and...more

Fenwick & West LLP

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

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In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

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