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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. Join the #GoodwinLaw conversation.
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 9h
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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).
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 3d
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 ...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 20d
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).
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 20d
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.
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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 ...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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.
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
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 ...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
Recent International Biosimilar Regulatory Updates

#Biosimilars #Regulatory #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/29/r...
Recent International Biosimilar Regulatory Updates
In the past few weeks, several biosimilar products have been granted marketing authorization in Europe and Japan, and additional products have been recommended for approval in Europe.
www.bigmoleculewatch.com
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
Factor Bioscience Sues Cellectis and AstraZeneca Alleging Infringement of Gene-Editing Patents

#CellandGeneTherapy #BigMoleculeWatch #GeneEditing

www.bigmoleculewatch.com/2025/09/26/f...
Factor Bioscience Sues Cellectis and AstraZeneca Alleging Infringement of Gene-Editing Patents
On September 26, 2025, Factor Bioscience Inc. (“Factor”) filed a complaint against Cellectis Inc., Cellectis SA, AstraZeneca PLC, AstraZeneca Ireland Limited, and AstraZeneca Holdings B.V., alleging i...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
FDA Approves Biocon’s Denosumab Biosimilars

#FDA #Biosimilars #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/26/f...
FDA Approves Biocon’s Denosumab Biosimilars
On September 16, 2025, the FDA approved Biocon Biologics Ltd.’s BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) as biosimilars to Amgen’s PROLIA® and XGEVA®, respectively.
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · 25d
Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation

#BPCIA #Litigation #Pharmaceuticals

www.bigmoleculewatch.com/2025/09/24/a...
Amgen Fires Back with Counterclaims in Aflibercept BPCIA Litigation
As we previously reported, on June 17, 2025, Regeneron filed a complaint against Amgen under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU, infringes U.S. Patent No. 12,331,099 (“the...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · Sep 23
Alvotech Files PGR Against Regeneron High-Dose Aflibercept Patent

#Patent #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/19/a...
Alvotech Files PGR Against Regeneron High-Dose Aflibercept Patent
On September 17, 2025, Alvotech USA Inc. and Alvotech hf. (Alvotech) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (the '036 patent), assigned to Regeneron Pharmaceuticals, Inc....
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · Sep 18
FDA Updates Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment & other Quality-Related Considerations

#FDA #Biosimilars #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/18/f...
FDA Updates Guidance on Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment & other Quality-Related Considerations
This month, FDA issued its new final guidance to replace a draft guidance that issued on May 22, 2019 titled “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Othe...
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Goodwin Law - Big Molecule Watch @goodwinlaw.bsky.social · Sep 12
Would Exercising March-in Rights Lower Biologic Prices?

#BPCIA #Congress #BigMoleculeWatch

www.bigmoleculewatch.com/2025/09/12/w...
Would Exercising March-in Rights Lower Biologic Prices?
The Bayh-Dole Act provides that the federal government retains certain rights in inventions it funds.  Many have sought to use those rights as a way to lower the cost of prescription drugs for consumers and for the federal government.
www.bigmoleculewatch.com