First Biosimilar Drug Approved for Non-Hodgkin Lymphoma

The US Food and Drug Administration recently announced the approval of the first biosimilar drug for patients with non-Hodgkin lymphoma in a press release. The drug is known as Truxima and is a biosimilar to rituximab, which is also marketed as Rituxan. The drug is approved for use in B-cell, CD20 positive non-Hodgkin lymphoma.

About Non-Hodgkin Lymphoma

Non-Hodgkin lymphoma is a group of blood cancers that, in some cases, can grow rapidly. This cancer affects a type of white blood cell called a lymphocyte. As non-Hodgkin lymphoma can include any type of lymphoma that is not Hodgkin’s lymphoma, they probably have diverse array of causes. Risk factors for the development of these cancers include infections by certain viruses and bacteria, exposure to chemicals such as herbicides, prior autoimmune diseases, prior radiation or chemotherapy, and some genetic conditions. Symptoms may include itching, swollen lymph nodes, fatigue, fever, weight loss, and night sweats. Treatment often includes chemotherapy, stem cell transplant, and, less commonly, immunotherapy. The five year survival rate for these cancers is around 71 percent in the US. To learn more about non-Hodgkin lymphoma, click here.

About Truxima and Biosimilar Drugs

Truxima is approved for use in non-Hodgkin lymphoma either on its own or in combination with chemotherapy. The approval of the drug is based various evidence and clinical data that affirms that the drug is a legitimate biosimilar to rituximab. With that being said, they should not be regarded as completely interchangeable products.

Biosimilars are similar to generic drugs in that they are manufactured after the original patent on a drug has expired. However, the term biosimilar specifically applies to biologic medical products. Unlike generics, biosimilars tend to be far more molecularly complex and are sensitive to changes in manufacturing processes. A biosimilar gains approval based on data which supports that it is close enough to a biologic medical product that has already been approved by the FDA. It must have no clinically significant differences in purity, safety, or effectiveness.

Truxima also carries the same side effects and health risks as rituximab. It is the 15th biosimilar drug that the FDA has approved so far.

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