Biosimilars – Alternative of a Biologic Drug

Ms. Rajni Yadav

Assistant Professor - Faculty of Pharmacy
Kalinga University

Biosimilar drugs and biosimilars are classes of drugs that are used to treat many complex conditions, like autoimmune disorders, inflammatory bowel disease, diabetes, cardiovascular disease, and many more.

Many people are unaware of biosimilars. According to FDA, biosimilars are biological products that are highly similar, but not identical to a reference product available. To receive the FDA approval, clinical studies need to be done and it must be similar to the reference product. For instance, scientists and researchers perform pharmacokinetic studies to study the absorption, distribution, metabolism, and excretion kinetics of drugs and also pharmacodynamic studies to understand the potency and efficacy of the drugs. Biosimilars should also work the same way, should show kinetics and dynamics the same as the reference products.

Biosimilars do not require any expensive or lengthy clinical trials as reference or biologics products, leading to fast access to additional therapeutic actions and cheaper costs. Separate marketing approval is required if the patent of the reference product expires. Biosimilars are not generic versions of biologics. The guidelines of the FDA for biosimilars say that biosimilars should include 4 lowercase letters after the name of the reference product. For example, in 2015 a biosimilar filgrastim-and was launched in the United States which was the biosimilar of the reference drug filgrastim. This drug is used to reduce the risk of neutropenia with fever in tumor patients who are receiving strong chemotherapy. The availability of filgrastim-and offers an alternative treatment option that product less expensive and so affordable for patients.

Other biosimilars are Amjevita (adalimumab-atto), Byooviz (ranibizumab-nuna), Semglee (Insulin glargine-yfgn), Riabni (rituximab-arrx), Hulio (adalimumab-fkjp), Ziextenzo (pegfilgrastim-bmez) and many more. Biosimilars differ from reference or biologics in cost, structural variation in clinically inactive components of drug, manufacturing process, exclusivity, naming convention, and FDA approval as an interchangeable pr. Hence biosimilars are good alternatives at a cheaper price and more biosimilars must be produced in the future.


  1. Alnita A. Jackson, DNP, APRN, FNP-C, CNE, May 2021.

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