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Subcutaneous Anti-Her2 Antibody Formulation

Patent No. EP2687202 (titled "Subcutaneous Anti-Her2 Antibody Formulation") was filed by F Hoffmann LA Roche on Jul 28, 2010. The application was issued on May 10, 2023.

Patent Summary

This liquid, highly concentrated, stable pharmaceutical formulation for subcutaneous injection comprises a pharmaceutically active anti-HER2 antibody (e.g., Trastuzumab) at a concentration of approximately 50 to 350 mg/ml. The composition includes a buffering agent (1 to 100 mM) maintaining a pH of 5.5 ± 2.0, a stabilizer or stabilizer mixture (1 to 500 mM), and a nonionic surfactant (0.01 to 0.08% w/v). Additionally, it contains a hyaluronidase enzyme (such as rHuPH20) at approximately 1500 to 12000 U/ml to enhance drug absorption and dispersion. The formulation is designed to minimize protein aggregation and immunogenicity, suitable for treating HER2-expressing diseases, including metastatic breast cancer and gastric cancer, either as a combined formulation, a kit, or within an injection device. All "about" values allow for ±10% variation.

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CompanyOpposition DateRepresentative
ACCORD HEALTHCAREFeb 12, 2024BRAND MURRAY FULLER

Dossier Documents

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EP2687202

F HOFFMANN LA ROCHE
Application Number
EP13166031A
Filing Date
Jul 28, 2010
Status
Granted And Under Opposition
Apr 7, 2023
Publication Date
May 10, 2023
External Links
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