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Big Molecule Watch

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By: Goodwin Procter

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Sean Anderson
Beth Ashbridge
Beth Ashbridge|Aru Goyal
Beth Ashbridge|Kevin DeJong

Latest from Big Molecule Watch

Big Molecule Watch

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

By Grace Truong
June 20, 2025

Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”) of Regeneron’s U.S. Patent No. 11,084,865 (the “’865 patent”). …

Big Molecule Watch

Regeneron Files Another Complaint Against Amgen in Aflibercept BPCIA Litigation

By Allegra Padula
June 20, 2025

On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”).  The ’099 patent issued on the same day,…

Big Molecule Watch

Biosimilar Manufacturers to Expand Offerings in Europe and Japan

By Joseph Molinari|Timothy Beavers
June 16, 2025

On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe.
Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan. …

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…

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