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 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

Characterization of Therapeutic Monoclonal Antibodies

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

Therapeutic mAbs, Biosimilars

Differences between Reference drugs (RMPs/RLDs) and Reference Standards

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

Biosimilars

Biosimilar Development: 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

Biosimilar comparability exercise

The biosimilar comparability exercise is a series of studies characterizing quality attributes of a reference and a biosimilar product. Approval of the biosimilar product by regulatory agencies is based on demonstrating high similarity between reference and biosimilar products. Guidelines for the conducting of biosimilar comparability exercises have been published by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Biosimilars

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.