BPOM ISSUEs A Circular Permit For Antibody Drugs For National Children's Production Monoclonals

Illustration of the Food and Drug Supervisory Agency (BPOM). (doc. science.lpkn.id)

JAKARTA - The Food and Drug Supervisory Agency (BPOM) issued a distribution permit for monoclonal antibody drug products with a Rituxical trademark produced domestically by PT Kalbio Global Media, a subsidiary of PT Kalbe Farma on Monday, January 30.

"This is a matter of pride and happiness, we can also convey the distribution permit of the first local-produced monoclonal biological antibody drug for lymphoma cancer," said Head of BPOM Penny K. Lukito during a press conference at the PT Kalbe Farma factory, Cikarang, Monday, January 30, was confiscated by Antara.

"This is an important thing because this is the first domestically produced monoclonal antibody drug for lymphoma," continued Penny.

Rituxicals are biosimilar products with the content of Ratuximab active substances in the preparation of concentrat solutions given intravenously.

The rutuximab is a monoclonal antibody that binds the CD20 transmembrane antigen in the lymphocyte of B cells that are produced by cancer cells specifically, giving rise to an immunological reaction that triggers cancer cells (breaking). This drug is used for the treatment of non-hodgkin lymphoma (NHL) and chromic lymphocitic cancer.

Furthermore, Penny explained that the Rituxical distribution permit was based on the results of a comparability test in the form of quality, non-clinical, and clinical. The test compared the Rituxical to the Rituximab innovator with the trading name Mabthera.

Through these series of tests, BPOM ensures that Rituxical products contain a Rituximab with similar characteristics to Mabthera. Penny also said that her party was involved in mentoring to ensure the drug met aspects of safety, quality, and efficacy.

"There is a clinical trial process that compares the products produced here with the Retuximab Retuxical drugs, which are comparable to the compatibility," said Penny.

For information, Rituxial was initially registered with BPOM on behalf of PT Kalbe Farma as an imported drug produced by a biotech company from Argentina, namely Sinergium Biotech SAS, which was released by the MABxience SASU. Furthermore, PT Kalbio Global Medika received technology transfers from the two biotech companies to make rutuxials in Indonesia.