Biosimilars

Here you can find information about biosimilars, from how they are produced to aspects of new developments regarding the research of these biologic drugs.

Therapeutic mAbs, Biosimilars

Therapeutic Monoclonal Antibody Characterization: Using Clinical-Grade Reference Drugs to Enhance Early Development

Characterization of therapeutic monoclonal antibodies are important to screen the right mAb molecule by defining the critical quality attributes.

Therapeutic mAbs, Biosimilars

Therapeutic Antibodies to Treat Cancer Targeting CD20

Therapeutic antibodies for cancer targeting CD20 have been successfully used in immunotherapies to treat B-cell malignancies and auto-immune diseases.

Therapeutic mAbs, Biosimilars

Reference Drugs (RMPs/RLDs) and Reference Standards: Exploring the Difference

It is important to first establish a reference standard while assessing biosimilarity between a biosimilar product and the reference product.

Biosimilars

Biosimilar Development: A Biocomparability Exercise

Monoclonal antibodies (mAbs) are an important class of biologics that have altered the treatment landscapes in several therapeutic areas such as cancer, auto-immune diseases, and viral infections.

Biosimilars

Exploring the Certificate of Analysis (CoA)

A Certificate of Analysis (CoA) is an important document provided with a range of manufactured products like food, chemicals, research products, and pharmaceutical products.