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Big Molecule Watch

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By: Goodwin Procter

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Sean Anderson
Beth Ashbridge
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Beth Ashbridge|Kevin DeJong

Latest from Big Molecule Watch

Big Molecule Watch

Third Circuit Holds That Granting Discovery Under Section 1782 Is Not a “Final” Judgment

By Alison Siedor
June 13, 2025

The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the decision…

Big Molecule Watch

Sandoz Launches PYZCHIVA® (Ustekinumab) Autoinjector in Europe

By Christopher Cassella
June 4, 2025

On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”  PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic…

Big Molecule Watch

Samsung Bioepis Secures Marketing Approval in Korea for its Biosimilar to Amgen’s Bone Cancer Drug Xgeva

By Beth Ashbridge
June 3, 2025

Samsung Bioepis Co., Ltd. has secured marketing approval in Korea for XBRYK, its biosimilar to Amgen’s bone cancer drug XGEVA, used to prevent fractures in those with bone metastases from solid tumors or multiple myeloma and to treat rare conditions…

Big Molecule Watch

EMA Issues Positive CHMP Opinions for Fresenius Denosumab Biosimilars

By Sam Herron
June 2, 2025

On May 27, 2025, Fresenius Kabi (“Fresenius”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Fresenius’s two denosumab biosimilar candidates.
The applications for the two candidates, biosimilars to Amgen’s PROLIA (denosumab)…

Big Molecule Watch

Celltrion, Samsung Bioepis, and Organon Receive Interchangeability Designations for Adalimumab Biosimilars

By Emma Murray
June 2, 2025

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars.  Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without intervention of the prescribing health care provider.
 
On May…

Big Molecule Watch

FDA Approves Bio-Thera and Hikma’s Ustekinumab Biosimilar

By Riley Wyberg
May 29, 2025

On May 22, 2025, the FDA approved Bio-Thera Solutions and Hikma Pharmaceuticals’ ustekinumab biosimilar, STARJEMZA® (ustekinumab-hmny) injection, referencing Janssen’s STELARA® (ustekinumab) injection.  This approval makes Bio-Thera the seventh company to receive FDA approval for an ustekinumab biosimilar, joining Amgen,…

Big Molecule Watch

FDA Approves BLA for Novavax’s COVID-19 Vaccine

By Tara Thigpen
May 23, 2025

On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64 years with at least one underlying condition…

Big Molecule Watch

Biogen Files Suit Against Neurimmune Over Rights to Bispecific Antibody

By Allegra Padula
May 21, 2025

On May 13, 2025, Biogen Inc. and Biogen MA Inc. (“Biogen”) filed a Complaint for Declaratory Judgment and Permanent Injunctive Relief against Neurimmune Holding AG and Neurimmune SubOne AG (“Neurimmune”) in the U.S. District Court for the District of Massachusetts. …

Big Molecule Watch

HyClone Seeks to Quash Amgen’s Subpoena Issued in Amgen/Accord Denosumab BPCIA Litigation

By Allegra Padula
May 20, 2025

On May 14, 2025, HyClone Laboratories, LLC (“HyClone”) filed a Motion to Quash in the U.S. District Court for the District of Utah, seeking to quash Amgen Inc.’s (“Amgen”) subpoena to HyClone issued in Amgen’s denosumab BPCIA case against Accord.…

Big Molecule Watch

Regeneron Awarded $407 Million in Amgen Antitrust Suit

By Darlene Staines
May 19, 2025

On May 15, 2025, a jury returned a verdict finding Amgen Inc. (“Amgen”) liable for antitrust violations and awarding Regeneron Pharmaceuticals, Inc. (“Regeneron”) over $400 million in damages.
As we reported previously, Regeneron filed its antitrust lawsuit in 2022 in…

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