Скачать или смотреть Biosimilars is a biologic that is similar to reference product.

Trastuzumab, also known as Herceptin, is the first targeted biosimilar medicine for breast cancer.



A biosimilar is exactly what its name implies — it is a biologic that is “similar” to another biologic medicine (known as a reference product).



Biologics or biological products are medicines made from living organisms through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions.



Biologics are used to prevent, treat or cure a variety of diseases including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders.



Biosimilars are highly similar to the reference product in terms of safety, purity and potency, but may have minor differences in clinically inactive components.



India is one of the leading manufacturers of similar biologics. India developed a new guideline in 2012 for the pre- and post-marketing approval of similar biologics. The guidelines also address the regulation of manufacturing process as well as quality, safety, and efficacy of similar biologics.

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