Development of the Drug Product Formulation of the Bevacizumab Biosimilar PF-06439535 (Bevacizumab-bvzr).

ABSTRACT:

Background

PF-06439535 (bevacizumab-bvzr; Zirabev^®) is a biosimilar of bevacizumab reference product (RP; Avastin^®). This study describes the formulation development for PF-06439535.

Methods

PF-06439535 was formulated in several buffers and stored for 12 weeks at 40 °C to determine the optimal buffer and pH under stressed conditions. Subsequently, PF-06439535 at 100 and 25 mg/mL was formulated in a succinate buffer with sucrose, edetate disodium dihydrate (EDTA), and polysorbate 80, and in the RP formulation. Samples were stored at - 40 °C to 40 °C for ≤ 22 weeks. The physicochemical and biological properties relevant to the safety, efficacy, quality, or manufacturability were investigated.

Results

When stored at 40 °C for 13 days, PF-06439535 de

SUBMITTER: Ingram RL 

PROVIDER: S-EPMC9985529 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature