Significance of Biosimilar Medications

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A Biosimilar is a biological product that is similar to a product already approved by FDA. Safety, potency, and effectiveness of a biosimilar are just like the reference drug. Biosimilar drugs could prove a support in treating all kinds of diseases. FDA’s biosimilar plan is in its full swing to improve the development of biosimilars and to encourage the manufacturers as well. This would also help patients to avail important medicines they require.

Adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) were previously being treated by Rituxan (rituximab) combined with chemotherapy. Truxima (rituximab-abbs) is the first biosimilar to Rituxan whose approval was granted by FDA to Celltrion.

After the discovery of Truxima, Scott Gottlieb assured that the efficacy of biosimilar medications would be keenly observed by FDA. Truxima is used as a single agent to treat relapsed follicular, CD20-positive B-cell NHL. It is given to those patients who haven’t received any prior treatment for CD20-positive B-cell NHL and also the ones in which disease is non-progressing. Chemotherapies are given according to the state of disease.

Truxima isn’t a product that could be used interchangeably but it’s a biosimilar which has been proved after a wide research. It’s structural and functional similarity has been proved after collecting data from the animal study, human pharmacokinetics, and immunogenicity.

Truxima has many side effects which include fever, low level of lymphocytes, chills, infections, and weakness. Pregnant and breastfeeding women should not take Truxima as it could harm the baby. Moreover, cardiac adverse reactions and renal toxicity can also occur.

Both Rituxan and Truxima contain a warning box on their labels. The indications in that box say that these drugs increase the risk of fatal infusion reactions, skin and mouth reactions, hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy.

At the time FDA approved Truxima a biosimilar to Rituxan, Hyrimoz was approved as a biosimilar to Humira and Udenyca was approved as a biosimilar to Humira.

https://en.m.wikipedia.org/wiki/Biosimilar

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm627009.htm

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