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Keytruda (Pembrolizumab) Priced at Rs 1.5 Lakh per Vial; Biosimilars Could Cut Cost by 70% Amid Patent Thicket Till 2028

Science & TechPolitySocial IssuesHIGH
Target:UPSC GS-IIIMPSCTeachingSSC GAPrelims HighMains HighStatic GK Link
16 Apr 2026
~2 min
Source: Indian Express
Key Data:Rs 1.5 lakh per 100mg vialPatent expiry 2028Cost reduction up to 70%4-8 times longer development
Bodies:Merck & Co.International Consortium of Investigative Journalists
Practice MCQs from today's news ▸
What This Article Covers

1.Immunotherapy drug Keytruda (pembrolizumab) costs Rs 1.5 lakh per 100mg vial, making treatment unaffordable and fueling a black market for counterfeit/refilled vials.

2.Pharma giant Merck uses a 'patent thicket' to extend monopoly on Keytruda till 2028, delaying cheaper biosimilars, which India is developing to reduce costs by up to 70%.

3.For exams, focus on India's patent law stance against 'evergreening', the complexities of biosimilar approval vs. generic drugs, and the strategic need for indigenous R&D like CAR-T therapy to tackle the nation's high cancer burden.

The Big Picture
Prelims · HighMains · High

A critical examination of the high cost and ethical issues surrounding life-saving cancer drugs like Keytruda, exposing patent strategies, regulatory gaps enabling a shadow economy, and India's push for affordable biosimilars and innovation in cancer therapy. Students must understand the intersection of intellectual property rights, public health, and India's regulatory challenges.

Exam Lens

Quick Exam Facts From News

Drug & CostKeytruda (Pembrolizumab): Rs 1.5 lakh per 100mg vial
Patent ExpiryPrimary patent on Pembrolizumab expires in 2028
Potential Cost CutBiosimilars could reduce cost by up to 70%
Development TimeBiosimilars take 4-8 times longer than conventional generics

1-Minute Revision

  • ›Drug & Cost: Keytruda (Pembrolizumab): Rs 1.5 lakh per 100mg vial
  • ›Patent Expiry: Primary patent on Pembrolizumab expires in 2028
  • ›Target this Data: Keytruda cost (Rs 1.5 lakh per 100mg vial) and patent expiry year (2028).
  • ›Target this Nodal Body: Drug regulatory authorities (implicitly, Central Drugs Standard Control Organization - CDSCO) for biosimilar approval.
  • ›Target this Legal Point: India's use of patent laws (Sections 3(d) of Patents Act) to prevent 'evergreening'.

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Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageMedium

The news discusses strategies like 'patent thickets' used by pharmaceutical companies. Which Indian law contains provisions, like Section 3(d), aimed at preventing such 'evergreening' practices?

Q2Statement-basedHard

Consider the following statements regarding the news article:

1. The drug Keytruda (pembrolizumab) is an example of immunotherapy used in cancer treatment.

2. Biosimilars of such drugs are identical chemical copies and can be developed as quickly as conventional generic medicines.

3. A key challenge mentioned is the 'patent thicket' strategy, which can delay the entry of cheaper alternatives even after the core patent expires.

Which of the statements given above is/are correct?

Q3Data-centricEasy

According to the investigation mentioned in the article, what is the cost of a 100 mg vial of the cancer drug Keytruda (pembrolizumab)?

Q4Application/ImpactMedium

What is the primary reason cited in the article for India's need to move beyond being just a manufacturer of affordable medicines to becoming a centre for innovation in biotech?

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