ArticleRecent Biosimilar Commercialization DevelopmentsMeitheal 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 SciencesGoodwin Procter LLP
ArticleSandoz Denosumab BLA Accepted By FDAThe 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 SciencesGoodwin Procter LLP
ArticleSandoz Launches Natalizumab BiosimilarOn 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 SciencesGoodwin Procter LLP
ArticleSimilis Bio And Blau Farmaceutica Enter Into Development And License Agreement For BiosimilarsOn 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 SciencesGoodwin Procter LLP
ArticleSun Pharma Launches ILUMYA® In IndiaOn 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 phototherapyUnited StatesFood, Drugs, Healthcare, Life SciencesGoodwin Procter LLP
ArticleTeva And Alvotech's Adalimumab Biosimilar Receives Interchangeable Status At FDAOn 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 SciencesGoodwin Procter LLP
ArticleUpdate On Celltrion's Infliximab BiosimilarCelltrion 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 SciencesGoodwin Procter LLP
ArticleBristol-Myers Squibb And AstraZeneca Settle Anti-PD-L1 Antibody Product LitigationWe previously reported on Bristol-Myers Squibb's ("BMS") complaint alleging AstraZeneca's PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899United StatesIntellectual PropertyGoodwin Procter LLP
ArticleCelltrion Files IPR Petition On Aflibercept PatentLast 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 PropertyGoodwin Procter LLP
ArticlePreliminary Injunction Issued Against Samsung Bioepis In Aflibercept BPCIA LitigationIn 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 PropertyGoodwin Procter LLP
ArticlePTAB Grants Petitioner Celltrion's Motion To Submit Supplemental Information In Tocilizumab IPRThe 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 PropertyGoodwin Procter LLP
ArticlePTAB Institutes IPRs Of Tocilzumab Patents Challenged By CelltrionOn 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 PropertyGoodwin Procter LLP
ArticleRegeneron Files BPCIA Complaint Against Sandoz Regarding Aflibercept BiosimilarOn 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 PropertyGoodwin Procter LLP
ArticleSamsung Files IPR Petition On Regeneron's Aflibercept PatentLast 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 PropertyGoodwin Procter LLP
ArticleTanvex Answers Genentech's Trastuzumab ComplaintAs 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 PropertyGoodwin Procter LLP
VideoGlobal 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 ConstructionGoodwin Procter LLP
ArticleOperational Real Estate: A Growing Opportunity Across Commercial REOperational 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 ConstructionGoodwin Procter LLP
VideoRECM 2023 | Featured Speaker, Roger Morales (Video)RECM 2023 | Featured Speaker, Roger Morales.United StatesReal Estate and ConstructionGoodwin Procter LLP
ArticleCFPB Enters Into Consent Order With Financial Technology CompanyOn May 7, 2024, the Consumer Financial Protection Bureau (CFPB) announced that it had entered into a consent order with a financial technology company.United StatesTechnologyGoodwin Procter LLP
ArticleHow To Reduce The Risk Of Copyright Infringement When Using Generative AI To Write CodeCompanies using generative AI should take steps before, during, and after writing code to avoid infringing copyrights on open source software.United StatesTechnologyGoodwin Procter LLP