https://www.pharmamanufacturing.com/articles/2011/095
A quiet but seismic shift is underway in global pharmaceuticals. Between 2025 and 2029, several blockbuster biologics — many of them cornerstones of cancer, autoimmune, and metabolic disease care — will go off patent.
This shift will not only open the doors to biosimilar competition, but also redefine market leadership, affordability, and global access. For India, this could be a turning point.
🌐 The Coming Patent Expiry Wave
According to a report by GlobalData (2024) and various public patent databases (USPTO, EMA, PMDA), key biologics losing exclusivity over the next five years include:
✅ 2025
- Perjeta (Genentech) – HER2+ breast cancer
- Benlysta (GSK) – Lupus
- Elelyso (Pfizer) – Gaucher disease
- Blincyto (Amgen) – Acute lymphoblastic leukemia
✅ 2026
- Kadcyla (Genentech) – HER2+ breast cancer
- Lartruvo (Lilly) – Soft tissue sarcoma
- Taltz (Lilly) – Psoriasis and arthritis
✅ 2027–2029
- Keytruda (Merck) and Opdivo (BMS) – Immuno-oncology
- Darzalex (J&J) – Multiple myeloma
- Ocrevus (Genentech) – Multiple sclerosis
- Cosentyx (Novartis) – Psoriasis and psoriatic arthritis
🎯 These products collectively account for over $150 billion in annual global sales (Evaluate Pharma, 2024).
🇮🇳 Why This Matters to India
India, long known as the pharmacy of the developing world, now has the opportunity to expand its leadership from generics into biosimilars — the next frontier in affordable medicine.
“India has one of the strongest biosimilar manufacturing infrastructures globally and is a key supplier to WHO-prequalified programs,” — IQVIA India Biopharma Trends Report, 2023
🏁 India vs China: Who Leads the Biologics Race?
| Criteria | India | China |
|---|---|---|
| Export readiness | ✅ Advanced | ⚠️ Emerging |
| Regulatory track record (US/EU) | ✅ Strong (Biocon, DRL, Zydus approvals) | ⚠️ Limited but growing |
| Government investment | ⚠️ Moderate | ✅ High (via Made in China 2025) |
| Domestic market potential | ⚠️ Price-sensitive | ✅ Massive with bulk procurement |
| Cost competitiveness | ✅ World leader | ⚠️ Comparable, but not lower |
“India is better positioned than China in biosimilar exports due to its established global regulatory footprint.” — Dr. Ranjit Madan, CEO, Life Sciences Sector Skill Development Council, India (2024)
🧠 What Indian Pharma Must Do
1. Fast-track USFDA/EMA submissions
Biosimilars for Keytruda, Trulicity, and Repatha are already in development. Speed and regulatory clarity will be crucial.
2. Co-develop & license
Partner with MNCs looking to extend the life cycle of their drugs or scale into low- and middle-income markets.
3. Invest in R&D + real-world evidence
Biosimilar adoption depends heavily on physician trust and clinical evidence, especially in oncology and immunology.
4. Market education and access models
Push for value-based contracts, physician KOL education, and institutional trust-building across emerging markets.
🗣️ Expert Voices
“The biologics patent cliff will transform pricing, market access, and treatment pathways — India must be ready to lead.”
— Dr. Anil Kukreja, VP Medical Affairs, AstraZeneca India
“Biocon Biologics has shown that Indian companies can achieve scale and trust in biosimilars globally — others must follow.”
— Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Ltd.
🌍 Final Word: A Defining Moment for India
India’s biosimilar industry is at a critical inflection point. With global biologics going off patent, Indian pharma must think boldly: to lead the world in affordable biologics, not just follow it.
The 2025–2029 window is narrow but rich with promise. Those who act now will shape not just balance sheets, but patient lives globally.
📚 Sources for Further Reading
- Evaluate Pharma Biologics Outlook 2024
- GlobalData Biosimilars Market Report, 2024
- USFDA “Purple Book” – Biologics Patent Expiry Database
- IQVIA India Biosimilars Landscape Report, 2023
- WHO Prequalified Biosimilars List (as of April 2025)
- EMA & CDSCO Biosimilar Approvals Tracker (2022–2025)
- Interviews from BioAsia and CPHI India, 2024–2025
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