From UPSC perspective, the following things are important :
Prelims level : Biosimilars
Mains level : Not Much
- 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.
What is Biosimilarity?
- Biosimilarity means that the biological product is highly similar to the reference product notwithstanding minor differences in clinically-inactive components.
- There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
- A biosimilar is a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’).
- Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
- Biological medicines contain active substances from a biological source, such as living cells or organisms (human, animals and microorganisms such as bacteria or yeast) and are often produced by cutting-edge technology.
Biosimilars vs generics
- Biosimilar drugs are often confused with generic drugs. Both are marketed as cheaper versions of costly name-brand drugs.
- Both are available when drug companies’ exclusive patents on expensive new drugs expire. And both are designed to have the same clinical effect as their pricier counterparts.
- 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 in duplication to accomplish the same therapeutic and clinical result.
- Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs that use living organisms as important ingredients.
- But many experts hope the two will share a critical commonality and that, like generics, biosimilars will dramatically lower the cost of biologic drugs.