ABP798, which Amgen is developing jointly with Allergan, is a biosimilar to Rituxan (rituximab) to treat non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL) and some inflammatory diseases such as rheumatoid arthritis (RA).

A biosimilar product is a biological product whose approval is based on proof that it’s highly similar to one already approved by the U.S. Food and Drug Administration (FDA) with no clinically significant differences in safety and effectiveness from the reference product.

How ABP798 works

Like Rituxan, ABP798 is a monoclonal antibody that targets the CD20 antigen expressed on the surface of B-cells. People with certain types of lymphomas usually have higher CD20 antigen levels.

ABP798 binds to the CD20 antigen and destroys B-cells. Two mechanisms may be involved in cell destruction: complement dependent cytotoxicity (CTC), in which antibodies target cells and activate the complement cascade leading to cell lysis, or antibody dependent cell-mediated cytotoxicity (ADCC), an immune mechanism through which cells are destroyed as a result of the interaction between antigens present on the cell surface and antibodies such as ABP798.

ABP798 in clinical trials

A Phase 3 study (NCT02747043) called JASMINE is now recruiting participants to assess whether ABP798 is as safe and effective as Rituxan in treating NHL.

Its primary objectives include the risk difference of the objective response rate (ORR) at 28 weeks. The ORR, a direct measure of a treatment’s antitumor activity, is the number of participants who see a predefined reduction in tumor size over a minimum period of time. The trial will likely finish by December 2018.

Other details

No side effects of ABP798 are available as studies are still ongoing. However, as a biosimilar to Rituxan, common side effects are likely to be similar to and include cold symptoms such as stuffy nose, sneezing, sore throat, fever, chills, body aches and tiredness.


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