Assessing Protein Content and Dimer Formation in the Bevacizumab Reference Product and Biosimilar Versions Marketed in Spain

Description

Making a biologic drug is a controlled process, and drug agencies ask whether copy drugs match the first drug batch after batch. The authors studied ten batches of the first bevacizumab drug, Avastin, made over ten years. They used protein concentration and dimer content as quality traits. They set limits with tolerance intervals and process capability tests, then checked three biosimilars sold in Spain since 2021.

Two methods were used: a quality range method with one sample per batch, and one that counts how much each batch varies on its own. The first drug's process stayed in statistical control, with spread close to what the test itself can show. All the copies matched on protein level. On dimer content, only one of the three matched. The authors offer these methods to judge whether plants make a drug the same way each time, and whether copies match.

Catalog record

Source: https://europepmc.org/articles/PMC11728500