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Goodwin Law - Big Molecule Watch
@goodwinlaw.bsky.social
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Posts updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biologics.

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

#Litigation #Aflibercept #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/18/r...
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...
www.bigmoleculewatch.com
November 20, 2025 at 6:58 PM
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Vera Therapeutics Submits BLA to FDA for Atacicept Fusion Protein

#Regulatory #FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/17/v...
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...
www.bigmoleculewatch.com
November 20, 2025 at 6:57 PM
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FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/14/f...
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...
www.bigmoleculewatch.com
November 20, 2025 at 6:55 PM
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New FDA Guidance Aims to Simplify the Biosimilar Approval Process

#FDA #Regulatory #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/14/n...
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In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein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.
www.bigmoleculewatch.com
November 20, 2025 at 6:54 PM
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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...
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 ...
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November 13, 2025 at 5:50 PM
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Hikma Launches Ustekinumab Biosimilar STARJEMZA

#Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/06/h...
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).
www.bigmoleculewatch.com
November 13, 2025 at 5:49 PM
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Samsung Biologics Completes Spin-Off and Launches Samsung Epis Holdings

#Biosimilars #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/06/s...
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...
www.bigmoleculewatch.com
November 13, 2025 at 5:43 PM
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Prefilled Syringe Presentation of GSK’s SHINGRIX Receives Positive CHMP Opinion

#Vaccine #EuropeanMedicinesAgency #BigMoleculeWatch

www.bigmoleculewatch.com/2025/11/03/p...
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...
www.bigmoleculewatch.com
November 3, 2025 at 9:07 PM
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Recent Biologics Decisions at Health Canada

#HealthCanada #Regulatory #Vaccine #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/31/r...
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...
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October 31, 2025 at 8:41 PM
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Takeda and Innovent Biologics Enter Collaboration Agreement on IBI343 and IBI363 Cancer Drugs

#Deal #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/31/t...
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...
www.bigmoleculewatch.com
October 31, 2025 at 8:36 PM
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FDA Grants Interchangeability Designation to Fresenius Kabi’s and Celltrion’s Denosumab Biosimilars

#FDA #BIgMoleculeWatch

www.bigmoleculewatch.com/2025/10/30/f...
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...
www.bigmoleculewatch.com
October 31, 2025 at 8:36 PM
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Teva and Prestige Biopharma Enter Licensing Agreement to Commercialize Their Trastuzumab Biosimilar

#Deal #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/30/t...
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...
www.bigmoleculewatch.com
October 31, 2025 at 8:35 PM
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FDA Approves Genentech’s GAZYVA® (obinutuzumab)

#FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/30/f...
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...
www.bigmoleculewatch.com
October 31, 2025 at 8:34 PM
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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...
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...
www.bigmoleculewatch.com
October 31, 2025 at 8:33 PM
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Xbrane Enters into Conditional Financing Deal Related to Ranibizumab Biosimilar

#Deal #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/24/x...
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).
www.bigmoleculewatch.com
October 31, 2025 at 8:30 PM
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FDA Regulatory Approval Updates

#FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/23/f...
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 ...
www.bigmoleculewatch.com
October 31, 2025 at 8:29 PM
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FDA Approves Celltrion’s Aflibercept Biosimilar

#Biosimilar #FDA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/14/f...
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).
www.bigmoleculewatch.com
October 14, 2025 at 7:34 PM
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Celltrion Announces Launch of AVTOZMA® (tocilizumab-anoh) Intravenous Formulation in the United States

#Launch #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/13/c...
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.
www.bigmoleculewatch.com
October 14, 2025 at 2:57 PM
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Kashiv BioSciences Omalizumab Biosimilar Application Submitted to FDA, Accepted by EMA

#Biosimilar #FDA #EMA #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/09/k...
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...
www.bigmoleculewatch.com
October 9, 2025 at 4:30 PM
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Biogen Ordered to Pay Genentech $88.3 Million in Past Royalties on Cabilly Patents

#Patents #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/07/b...
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...
www.bigmoleculewatch.com
October 9, 2025 at 4:29 PM
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PTAB Issues Four IPR Written Decisions in Merck and Johns Hopkins Pembrolizumab Dispute

#PTAB #IPR #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/p...
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 ...
www.bigmoleculewatch.com
October 9, 2025 at 4:15 PM
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Amgen and Samsung Bioepis Settle Denosumab BPCIA Case

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/a...
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...
www.bigmoleculewatch.com
October 9, 2025 at 4:05 PM
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Court Denies Amgen Motion to Dismiss in Etanercept Antitrust Case

#Antitrust #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/06/c...
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...
www.bigmoleculewatch.com
October 9, 2025 at 4:02 PM
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FDA Approves Seventh Denosumab Biosimilar: Richter and Hikma’s Enoby and Xtrenbo

#FDA #Biosimilar #BigMoleculeWatch

www.bigmoleculewatch.com/2025/10/02/f...
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.
www.bigmoleculewatch.com
October 9, 2025 at 4:02 PM
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Aflibercept BPCIA Multi-District Litigation Updates

#BPCIA #Litigation #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/30/a...
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 ...
www.bigmoleculewatch.com
October 9, 2025 at 3:47 PM