Tagged as: Aflibercept

New Patents Listed in the Purple Book for Regeneron’s EYLEA

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance.  As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022.  That original list contained 29 patents, including…

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Samsung Files IPR Petition on Regeneron's Aflibercept Patent

Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals.  According to the petition, the claims are directed to the use of aflibercept to treat angiogenic eye disorders, including diabetic macular edema and age-related macular degeneration. As we…

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Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023 Trial

As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On April 19, the Court issued a claim construction order construing seven terms from the claims of the four…

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Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation

As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022.  The Court’s scheduling order, issued in October…

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Celltrion Announces Phase III Results for Aflibercept Biosimilar

On April 3, 2023, Celltrion announced positive 24-week results from its global Phase III Clinical Trial of CT-P42 (aflibercept), a biosimilar referencing Regeneron’s EYLEA.  The trial is a 52-week trial in 348 patients with diabetic macular edema (DME) across thirteen countries. The primary endpoint was the change in best corrected…

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Aflibercept IPRs Update

On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572.  As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen…

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Celltrion and Samsung File IPR Petitions on Aflibercept Patents

Celltrion and Samsung recently filed IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept.  Specifically, Celltrion and Samsung have each filed petitions challenging U.S. Patent No. 10,130,681: IPR2023-00442 (Samsung), IPR2023-00532 (Celltrion), and U.S. Patent No. 10,888,601: IPR2023-00566 (Samsung), IPR2023-00533 (Celltrion). As we previously reported, Mylan…

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FDA Approves EYLEA® (Aflibercept) for Treatment of Retinopathy of Prematurity

On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants—the first pediatric approval for this indication. Regeneron reported that the approval is supported by data from FIREFLEYE and BUTTERFLEYE—two phase III clinical trials comparing 0.4…

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Biosimilar Clinical Trial Updates

Big Molecule Watch monitors for biosimilar clinical trial results. Here we report on four recent announcements concerning biosimilars of natalizumab, trastuzumab, daratumumab, and aflibercept. On January 23, 2023, researchers published the results of a phase III clinical trial demonstrating that PB006, Polpharma Biologics SA’s biosimilar to Biogen’s approved treatment TYSABRI®…

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Celltrion Files IPR Petition on Aflibercept Patent

Last week, Celltrion filed an IPR petition, PTAB IPR2023-00462, seeking cancellation of claims 1-18 of U.S. Patent No. 10,464,992 (“the ’992 patent”), assigned to Regeneron Pharmaceuticals, Inc.  According to the Petition, the challenged claims of the ’992 patent “encompass a formulation comprising the VEGF inhibitor protein, aflibercept, which Regeneron markets…

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