Biosimilar Medicine – Burning Issues – Free PDF Download

Context

• A renowned pharma company has launched in India Versavo (bevacizumab), a biosimilar of Roche’s Avastin is indicated for the treatment of several types of cancers.

Biosimilarity?

• Biosimilarity means that the biological product is highly similar to the reference product
• No clinically meaningful differences

• Biological medicine highly similar to another already approved biological medicine Biosimilars are approved according to the same standards of pharmaceutical quality.
• Biological medicines contain active substances from a biological source.

Biosimilars vs generics

• Both are available when drug companies’ exclusive patents on expensive new drugs expire.
• But biosimilar drugs and generic drugs are very different, mainly because while generic drugs are identical to the original in chemical composition, biosimilar drugs are “highly similar,” but close enough
• Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs Need for biosimilars
• More affordable than biologics, the high cost of which often puts them out of reach of many patients
• Targeted they are toward treating non-communicable diseases such as cancer, asthma, and arthritis
• An alarming spike is being seen across developing countries in the prevalence of non-communicable diseases
• For example, diabetes is fast becoming an epidemic in developing countries, with rates rapidly catching up with those of the developed world

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