| abstract |
The application describes a highly concentrated, stable pharmaceutical composition with pharmaceutical activity of an anti-CD20 antibody, such as, for example, rituximab, ocrallumab or HuMab <CD20>, or a mixture of these antibody molecules, intended for subcutaneous injection. In particular, the application describes compositions that, in addition to an appropriate amount of an anti-CD20 antibody, contain an effective amount of at least one gualuronidase enzyme, in the form of a combined composition, or in the form used for co-administration. These compositions also contain at least one buffering agent, such as, for example, a histidine buffer, a stabilizer, or a mixture of two or more stabilizers (for example, a saccharide, such as, for example, α, α-trehalose dihydrate, or sucrose, and optionally methionine in as a second stabilizer), a non-ionic surfactant and, in an effective amount, at least one gualuronidase enzyme. Methods for the preparation of these compositions and methods for their use are also described. |