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5) What are Biosimilars? How are they different from Generic drugs? Discuss the possible prospects they hold for the Indian pharma industry.(250 words)

Topic:  Indigenization of technology and developing new technology.

5) What are Biosimilars? How are they different from Generic drugs? Discuss the possible prospects they hold for the Indian pharma industry.(250 words)

Why this question:

Pharma major Dr. Reddy’s Laboratories Ltd has launched ‘Versavo (bevacizumab)’, a biosimilar of Roche’s Avastin in India. The drug is for the treatment of several types of cancers.

Key demand of the question:

The answer must detail upon the concept of Biosimilars, compare them with Generic drugs and discuss the potential they hold for Indian Pharma Industry.

Directive:

DiscussThis is an all-encompassing directive – you have to debate on paper by going through the details of the issues concerned by examining each one of them. You have to give reasons for both for and against arguments.

Structure of the answer:

Introduction: 

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

Body:

Discussion should include the following: 

Biosimilars are ‘similar biologic drugs’, clinically equivalent, in terms of safety and efficacy, to biologic medicines. When the patent surrounding an original biologic’s formula is no longer protected, others companies can release cheaper biosimilars with no clinically meaningful differences.

Biosimilars v/s Generics – Nature of the drug, Manufacturing and testing, functioning etc.

Discuss significance – first explain issues plaguing Indian pharma industry and in what way Biosimilars can aid to fix issues.

Both Biosimilars and generic drugs are hugely important for affordable healthcare, and in recognition of this, Indian patent laws provide stringent protections against the practice of ‘evergreening’ by original drug manufacturers.

Conclusion:

Conclude with way forward.

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