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  • Article

    Recent Biosimilar Commercialization Developments

    Meitheal and Tonghua Dongbao will be jointly responsible for development and supply, with the expectation of achieving FDA approval in 2026.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Sandoz Denosumab BLA Accepted By FDA

    The US FDA has accepted a Biologics License Application (BLA) from Sandoz for a proposed denosumab biosimilar. In its press-release, Sandoz stated that the "application includes all indications...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Sandoz Launches Natalizumab Biosimilar

    On November 17, 2025, Sandoz announced the launch of TYRUKO® (natalizumab-sztn) in the United States as the first and only biosimilar for the treatment of relapsing forms of multiple sclerosis.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Similis Bio And Blau Farmaceutica Enter Into Development And License Agreement For Biosimilars

    On October 25, 2022, JSR Life Sciences and Blau Farmaceutica announced that Similis Bio, JSR Life Sciences's business unit focused on biosimilar development, has signed its first development and license agreement...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Sun Pharma Launches ILUMYA® In India

    On December 1, 2025, Sun Pharmaceutical Industries Ltd. ("Sun Pharma") announced the launch of ILUMYA® (tildrakizumab-asmn) in India. ILUMYA® is a humanized monoclonal antibody injection indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    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...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Update On Celltrion's Infliximab Biosimilar

    Celltrion recently confirmed that it proved the effectiveness of its subcutaneous infliximab biosimilar, RemsimaSC (CT-P13 SC) in two global Phase III trials.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Bristol-Myers Squibb And AstraZeneca Settle Anti-PD-L1 Antibody Product Litigation

    We previously reported on Bristol-Myers Squibb's ("BMS") complaint alleging AstraZeneca's PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Celltrion Files IPR Petition On Aflibercept Patent

    Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 ("the '992 patent"), assigned to Regeneron Pharmaceuticals, Inc.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Preliminary Injunction Issued Against Samsung Bioepis In Aflibercept BPCIA Litigation

    In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    PTAB Grants Petitioner Celltrion's Motion To Submit Supplemental Information In Tocilizumab IPR

    The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion's motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264...
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    PTAB Institutes IPRs Of Tocilzumab Patents Challenged By Celltrion

    On August 31, 2022, the PTAB instituted two inter partes reviews of Chugai and Roche's tocilizumab patents challenged by Celltrion, adding to the growing list of IPRs instituted against the tocilizumab patent estate.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Regeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept Biosimilar

    On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz's ENVEEZU (aflibercept-abzv).
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Samsung Files IPR Petition On Regeneron's Aflibercept Patent

    Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 ("the '572 patent"), owned by Regeneron Pharmaceuticals.
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Tanvex Answers Genentech's Trastuzumab Complaint

    As we previously reported, on June 3, 2022, Genentech filed a complaint against Tanvex in the U.S. District Court for the Southern District of Florida, alleging infringement of three patents...
    United StatesIntellectual Property
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Video

    Global Flows Of Capital (Video)

    Bryan Donohoe, Partner, Co-Head of US Real Estate, Ares US Real Estate Adam Gallistel, Regional Head, RE Americas, GIC...
    United StatesReal Estate and Construction
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    Operational Real Estate: A Growing Opportunity Across Commercial RE

    Operational real estate (ORE) has emerged as a focal point for commercial real estate investors eager to transition from passive to active ownership strategies.
    United StatesReal Estate and Construction
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Video

    RECM 2023 | Featured Speaker, Roger Morales (Video)

    RECM 2023 | Featured Speaker, Roger Morales.
    United StatesReal Estate and Construction
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    CFPB Enters Into Consent Order With Financial Technology Company

    On May 7, 2024, the Consumer Financial Protection Bureau (CFPB) announced that it had entered into a consent order with a financial technology company.
    United StatesTechnology
    Goodwin Procter LLP
    Goodwin Procter LLP
  • Article

    How To Reduce The Risk Of Copyright Infringement When Using Generative AI To Write Code

    Companies using generative AI should take steps before, during, and after writing code to avoid infringing copyrights on open source software.
    United StatesTechnology
    Goodwin Procter LLP
    Goodwin Procter LLP

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