Mylan-Biocon seek USFDA nod for biosimilar version of cancer drug
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Hyderabad: Drug makers Mylan NV and Biocon Ltd on Tuesday said they had submitted their first biologics licence application (BLA) to the US Food and Drug Administration (USFDA) seeking approval for a biosimilar version of cancer drug trastuzumab in the US.
The proposed biosimilar version of trastuzumab is indicated for treatment of certain breast and gastric cancers.
Mylan and Biocon said in a statement they believed that their application has the potential to be the first submission of a proposed biosimilar trastuzumab in the US
A biosimilar is a complex biological product that follows a different approval pathway compared to chemical drugs.
Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from it.