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4 months ago

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.

Sandoz Launches Natalizumab Biosimilar

#Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/24/s...

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4 months ago

Sandoz and EirGenix Enter Licensing Agreement to Commercialize Proposed Pertuzumab Biosimilar On November 12, 2025, Sandoz announced a licensing agreement with EirGenix to commercialize EG1206A (pertuzumab), a proposed biosimilar of Genentech’s PERJETA® (pertuzumab).

Sandoz and EirGenix Enter Licensing Agreement to Commercialize Proposed Pertuzumab Biosimilar

#Biosimilar #Licensing #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/24/s...

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4 months ago

Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar On November 14, 2025, Amgen, Inc. (“Amgen”) launched another BPCIA denosumab litigation when it filed a complaint in the U.S. District Court for the District of New Jersey against Alkem Laboratories L...

Amgen Files BPCIA Complaint Against Alkem Related to Denosumab Biosimilar

#BPCIA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/21/a...

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4 months ago

FDA Approves Accord BioPharma’s Denosumab Biosimilars On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively.  This...

FDA Approves Accord BioPharma’s Denosumab Biosimilars

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/21/f...

Goodwin Law - Big Molecule Watch

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4 months ago

FDA Accepts Sanofi and Regeneron’s Dupixent sBLA for Priority Review On November 11, 2025, Sanofi and Regeneron announced that the FDA accepted for priority review its supplemental biologics license application (“sBLA”) for Dupixent (dupilumab) in the treatment of adul...

FDA Accepts Sanofi and Regeneron’s Dupixent sBLA for Priority Review

#FDA #Regulatory #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/20/f...

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4 months ago

Regeneron Moves to Strike and Dismiss Amgen’s Counterclaims in Aflibercept Litigation On November 12, 2025, Regeneron filed a Motion to Strike Certain Affirmative Defenses and Dismiss Certain Counterclaims against Amgen in the aflibercept patent litigation in the U.S. District Court fo...

Regeneron Moves to Strike and Dismiss Amgen’s Counterclaims in Aflibercept Litigation

#Litigation #Aflibercept #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/18/r...

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4 months ago

Vera Therapeutics Submits BLA to FDA for Atacicept Fusion Protein On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept...

Vera Therapeutics Submits BLA to FDA for Atacicept Fusion Protein

#Regulatory #FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/17/v...

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4 months ago

FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab).  This is the first pertuzum...

FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/14/f...

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4 months ago

New FDA Guidance Aims to Simplify the Biosimilar Approval Process In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products.

New FDA Guidance Aims to Simplify the Biosimilar Approval Process

#FDA #Regulatory #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/14/n...

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4 months ago

Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars On November 6, 2025, Amgen, Inc. (Amgen) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy's ...

Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars

#BPCIA #Biosimilar #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/10/a...

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4 months ago

Hikma Launches Ustekinumab Biosimilar STARJEMZA On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny).

Hikma Launches Ustekinumab Biosimilar STARJEMZA

#Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/06/h...

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4 months ago

Samsung Biologics Completes Spin-Off and Launches Samsung Epis Holdings On November 3, 2025, Samsung Biologics announced the completion of the spin-off of its investment and subsidiary management business unit, and the establishment of Samsung Epis Holdings, an investment...

Samsung Biologics Completes Spin-Off and Launches Samsung Epis Holdings

#Biosimilars #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/06/s...

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5 months ago

Prefilled Syringe Presentation of GSK’s SHINGRIX Receives Positive CHMP Opinion On October 21, 2025, GSK announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for the shingle vaccine SHINGRIX (reco...

Prefilled Syringe Presentation of GSK’s SHINGRIX Receives Positive CHMP Opinion

#Vaccine #EuropeanMedicinesAgency #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/03/p...

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5 months ago

Recent Biologics Decisions at Health Canada In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab inj...

Recent Biologics Decisions at Health Canada

#HealthCanada #Regulatory #Vaccine #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/31/r...

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5 months ago

Takeda and Innovent Biologics Enter Collaboration Agreement on IBI343 and IBI363 Cancer Drugs Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercial...

Takeda and Innovent Biologics Enter Collaboration Agreement on IBI343 and IBI363 Cancer Drugs

#Deal #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/31/t...

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5 months ago

FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars.  Interchangeable biosimilars can be substituted for the reference product at t...

FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars

#FDA #BIgMoleculeWatch

www.bigmoleculewatch.com/2025/10/30/f...

Goodwin Law - Big Molecule Watch

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5 months ago

Teva and Prestige Biopharma Enter Licensing Agreement to Commercialize Their Trastuzumab Biosimilar On October 20, 2025, Teva Pharmaceuticals International GmbH (“Teva”) announced a licensing agreement with Prestige BioPharma Ltd. (“Prestige BioPharma”) to commercialize TUZNUE® (trastuzumab), a bios...

Teva and Prestige Biopharma Enter Licensing Agreement to Commercialize Their Trastuzumab Biosimilar

#Deal #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/30/t...

Goodwin Law - Big Molecule Watch

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5 months ago

FDA Approves Genentech’s GAZYVA® (obinutuzumab) On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN).  Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by...

FDA Approves Genentech’s GAZYVA® (obinutuzumab)

#FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/30/f...

Goodwin Law - Big Molecule Watch

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5 months ago

California’s Governor Newsom Announces that State Sponsored Insulin Pen will be Available Jan 1, 2026 On October 17, Governor Newsom announced that California will be launching the “first and only” state contracted affordable insulin. Through an agreement with nonprofit generic drug manufacturer Civic...

California’s Governor Newsom Announces that State Sponsored Insulin Pen will be Available Jan 1, 2026

#Newsom #Insulin #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/25/c...

Goodwin Law - Big Molecule Watch

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5 months ago

Xbrane Enters into Conditional Financing Deal Related to Ranibizumab Biosimilar As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab).

Xbrane Enters into Conditional Financing Deal Related to Ranibizumab Biosimilar

#Deal #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/24/x...

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5 months ago

FDA REGULATORY APPROVAL UPDATES On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled ...

FDA Regulatory Approval Updates

#FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/23/f...

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5 months ago

FDA Approves Celltrion’s Aflibercept Biosimilar On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept).

FDA Approves Celltrion’s Aflibercept Biosimilar

#Biosimilar #FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/14/f...

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5 months ago

Celltrion Announces Launch of AVTOZMA® (tocilizumab-anoh) Intravenous Formulation in the United States On October 2, 2025, Celltrion, Inc. (“Celltrion”) announced the commercial launch of AVTOZMA® (tocilizumab-anoh), a biosimilar to ACTEMRA® in the United States.

Celltrion Announces Launch of AVTOZMA® (tocilizumab-anoh) Intravenous Formulation in the United States

#Launch #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/13/c...

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5 months ago

Kashiv BioSciences Omalizumab Biosimilar Application Submitted to FDA, Accepted by EMA On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar to Nov...

Kashiv BioSciences Omalizumab Biosimilar Application Submitted to FDA, Accepted by EMA

#Biosimilar #FDA #EMA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/09/k...

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5 months ago

Biogen Ordered to Pay Genentech $88.3 Million in Past Royalties on Cabilly Patents On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc. (Biogen) to pay Genentech, Inc. (Genentech) $88,348,123 in unpaid royalties plus interest...

Biogen Ordered to Pay Genentech $88.3 Million in Past Royalties on Cabilly Patents

#Patents #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/07/b...

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5 months ago

PTAB Issues Four IPR Written Decisions in Merck and Johns Hopkins Pembrolizumab Dispute On September 18 and 19, 2025, the Patent Trial and Appeals Board (PTAB) issued final written decisions for four inter partes review (IPR) challenges brought by Merck Sharp & Dohme LLC (Merck) against ...

PTAB Issues Four IPR Written Decisions in Merck and Johns Hopkins Pembrolizumab Dispute

#PTAB #IPR #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/p...

Goodwin Law - Big Molecule Watch

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5 months ago

Amgen and Samsung Bioepis Settle Denosumab BPCIA Case On September 5, 2025, the U.S. District Court for the District of New Jersey entered a Consent Order and Judgment resolving the denosumab BPCIA litigation between Amgen, Inc. (Amgen) and Samsung Bioep...

Amgen and Samsung Bioepis Settle Denosumab BPCIA Case

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/a...

Goodwin Law - Big Molecule Watch

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5 months ago

Court Denies Amgen Motion to Dismiss in Etanercept Antitrust Case On September 30, the U.S. District Court for the Eastern District of Virginia granted in part and denied in part the Motion to Dismiss filed by Amgen, Inc. and Immunex Corporation (Amgen) in a class a...

Court Denies Amgen Motion to Dismiss in Etanercept Antitrust Case

#Antitrust #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/c...

Goodwin Law - Big Molecule Watch

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5 months ago

FDA Approves Seventh Denosumab Biosimilar: Richter and Hikma’s Enoby and Xtrenbo On September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc.

FDA Approves Seventh Denosumab Biosimilar: Richter and Hikma’s Enoby and Xtrenbo

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/02/f...

Goodwin Law - Big Molecule Watch

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5 months ago

Aflibercept BPCIA Multi-District Litigation Updates The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. (“Regeneron”) filing suit under the ...

Aflibercept BPCIA Multi-District Litigation Updates

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/30/a...