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Conference Overview
The 21st Biosimilars Congregation 2026 brings together CSOs, CMOs, regulatory heads, and R&D leaders from India’s biosimilars ecosystem to address the sector’s most pressing priorities — from regulatory reform to global competitiveness. Held on 10th December 2026 in Mumbai, it positions itself as the platform “where biosimilar leaders meet innovation, strategy & success.”
Portfolio Strategy
Identifying high-value molecules and billion-dollar opportunities through patent expiry evaluation, licensing, and lifecycle planning.
Innovation & Growth
Charting the next decade of biosimilars through global leadership, sustainable growth, and industry-wide collaboration.
Tech & Evidence
Exploring how AI, real-world evidence, and digital tools are transforming biologics development and monitoring.
Patient Access
Building trust among physicians, payers, and patients to accelerate biosimilar adoption and affordability.
Regulatory Pathways
Examining India's evolving regulatory framework and its emergence as a global biosimilars hub.
Manufacturing Excellence
Scaling India's manufacturing capabilities to achieve global quality leadership and export competitiveness
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As biologics patents expire worldwide and healthcare systems demand affordable alternatives, India stands at a pivotal juncture in the biosimilars race. The 21st Biosimilars Congregation 2026, taking place on 10th December in Mumbai, unites CSOs, CMOs, regulatory heads, and scientific leaders to chart the path forward. This year’s conference sharpens its focus on building a sustainable, competitive framework — spanning pricing strategies, procurement practices, and regional market access — while examining what truly drives biosimilar uptake beyond cost alone. From next-gen manufacturing to AI-powered real-world evidence, sessions will equip attendees with actionable regulatory updates and market strategies. Delegates will benchmark against industry frontrunners and leave with concrete plans to navigate R&D costs, regulatory hurdles, and rising commercial opportunity.
Speakers
Attendees
Hrs NETWORKING
SESSIONS
OUR ATTENDEES
Trusted by Industry Leaders Worldwide
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WHY SHOULD YOU ATTEND?
The 21st Biosimilars Congregation 2026 brings India's biosimilars leaders together for a day of high-level strategy, regulatory insight, and networking in Mumbai on 10th December 2026. With CSOs, CMOs, and regulatory heads from across the industry, the event unites the entire biosimilars value chain to tackle affordability, access, and innovation
Expert Insights
Hear from CXOs and senior leaders at Cipla, Biocon, Lupin, Pfizer, and other industry frontrunners on the latest strategies and challenges
Regulatory Clarity
Get updates on India's evolving regulatory framework and pathways for next-generation biosimilars approval.
Market Access
Learn how to win trust with physicians, payers, and patients while navigating pricing and affordability pressures.
Global Benchmarking
Compare your approach against industry frontrunners and build immediate action plans for R&D and market entry hurdles.
Networking & Exhibition
Connect with peers across the value chain and explore cutting-edge innovations at the co-located exhibition.
Meet Our Expert Speakers
OUR EVENT SCHEDULE
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
An opportunity to meet and network with your webinar colleagues online.
DEVELOPMENT / COMMERCIALIZATION
09:30 – Keynote Address - Strategic Portfolio Planning: Identifying the Next Billion-Dollar Biosimilar Opportunities.
- Evaluating global patent expiry opportunities.
- Selecting high-value molecules for development.
- Competitive landscape and portfolio prioritization.
- Intellectual property and lifecycle management strategies.
- Strategic partnerships and licensing opportunities.
- Long-term portfolio planning for sustainable growth.
REHAN NETARWALA
Clinevo Technologies
10:00 - 11:00 Panel Discussion 1: Integrated Safety in Pharmacovigilance
Unifying Data, AI and Cross-Functional Collaboration to Shape the Future of Patient Safety
SARVESH SINGH
Telangana Lifesciences
TRENDS & STRATERGIES
10:00 – PANEL DISCUSSION WITH EXPERTS – The Next Decade of Biosimilars: Driving Innovation, Global Leadership & Sustainable Growth.
10:00 – PANEL DISCUSSION WITH EXPERTS - The Next Decade of Biosimilars: Driving Innovation, Global Leadership & Sustainable Growth.
Moderator
ZINA SADEQ
Amicus Therapeutics
Panellists
SEEMA BHANDARKAR
Aurigene Pharmaceutical
DEBASHIS SARKAR
Aurobindo Pharma
VISHRUT AWASTHI
Amneal Pharmaceuticals
DILIPSINH CHAUHAN
Enzene Biosciences
10:50 Morning Coffee/Tea & Discussion
TECH – AI / RWE
11:20 – PANEL DISCUSSION WITH EXPERTS - Beyond Biosimilars: Real-World Evidence, AI & Future Technologies Transforming Biologics
Moderator
KAVITA LAMROR
Maxis Clinical Sciences
Panellists
SANTOSH TAUR
Pfizer
PANKAJ THAKUR
Hetero
DILIP PAWAR
BDR Pharmaceuticals
ISHWAR BAJAJ
Biocon
10:00: Panel Discussion 1: Integrated Safety in Pharmacovigilance
12:10 - Topic TBC
Explore the definitions and global regulatory trends currently shaping the combination products ecosystem. Highlighting the universal challenges
impacting industry stakeholders, regulators, and suppliers, while sharing best practices for navigating future innovations and ecosystem shifts. Emphasize
the role India (People, Process and Technology) plays in the evolution
KHAUDEJA BANO
Roche – Genentech (USA)
12:30 – Networking luncheon
PATIENT ACCESS
09:50 – Keynote- Intelligent Drug Safety: How AI is Redesigning Pharmacovigilance
Explore the definitions and global regulatory trends currently shaping the combination products ecosystem. Highlighting the universal challenges
impacting industry stakeholders, regulators, and suppliers, while sharing best practices for navigating future innovations and ecosystem shifts. Emphasize
the role India (People, Process and Technology) plays in the evolution
SIVA KUMAR BUDDHA
Amgen
PATIENT ACCESS
13:30 – PANEL DISCUSSION WITH EXPERTS - Accelerating Patient Access to Biosimilars: Winning the Trust of Physicians, Payers & Patients.
Moderator
SIVA KUMAR BUDDHA
Amgen
Panellists
AMARNATH SUGUMARAN
Cipla
KUSHAL SARDA
Alkem Laboratories
ABHI KAPASHI
Bharat Serums & Vaccines
PRITHA KAR
Pfzier
SALEEL RAUT
Amneal Pharmaceuticals
MANISH MAHAJAN
Zydus Group
DATTATRAY PAWAR
Alkem Laboratories
DATTATRAY PAWAR
Alkem Laboratories
SALEEL RAUT
Amneal Pharmaceuticals
MANISH MAHAJAN
Zydus Group
REGULATORY
14:20 – Biosimilar Session: “India – As a Biosimilar Hub”
- The Rise of India’s Biosimilar Landscape
- Evolving Regulatory Framework.
- Critical Industry Challenges to Overcome.
- The Strategic Way Forward
APARNA PRABHUNE
Wockhardt
14:50 – Afternoon Tea/Coffee
MANUFACTURING
15:20 – PANEL DISCUSSION WITH EXPERTS - Building India’s Global Biosimilars Manufacturing Powerhouse: Excellence, Scale & Quality Leadership
Moderator
ANUJA JAWALE
Kenvue
Panellists
MANNAN KHAMBATI
Bharat Serums and Vaccines
SHUVANKAR BALLAV
Ipca Laboratories
SOURABH FULMALI
Sanofi
PRASHANT GODSE
Enzene Bio Sciences
REGULATORY
16:10 – PANEL DISCUSSION WITH EXPERTS - From Development to Approval: Redefining Clinical & Regulatory Pathways for Next-Generation Biosimilars
Moderator
ASHISH DWIVEDI
Synapmed
Panellists
ABHISHEK SINHA
Advanz Pharma
AKSHAYA ODAK
Lupin
AMOL CHOULWAR
Cipla
RAVI CHHATANI
Teva Pharmaceuticals
ABHISHEK TONGIA
Abbott
KAUSTUBH BERDE
Wockhardt
VIPUL V CHHEDA
Intas Pharmaceuticals
VIPUL V CHHEDA
Intas Pharmaceuticals
ABHISHEK TONGIA
Abbott
KAUSTUBH BERDE
Wockhardt
17:00 – Closing remarks and end of conference
12:20 – Automated Literature Screening and Extraction
Speaker TBC
Clinevo Technologies
BHAVISHYA SALUJA
Ultragenic
SIGNAL DETECTION
14:20 – The Foundation for Effective AI Use in Signal Detection
GOPAL MURALIDHARAN
Pivot Path
SIGNAL
14:40 – Change Management and Stakeholder Alignment: Keys to Pharmacovigilance Business Transformation
Pharmacovigilance transformation extends beyond technology adoption and requires effective change management. Aligning internal and external stakeholders through shared objectives, communication and governance which minimizes resistance and supports seamless implementation of new processes and digital innovations. This session explores practical strategies for stakeholder alignment that enable compliant, patient-centric, and sustainable business transformation in PV.
INDER SACHDEVA
Syneos Health
GROWING ROLE OF RWE / RWD
15:30 – Discussion With Experts – Role of RWE in Modern Pharmacovigilance. RWD in Drug Safety: Opportunities, Challenges. Harnessing them to strengthen PV and patient safety
Moderator
SHRADDHA BHANGE
Sandoz
Panellists
HANUMANTHA RAO KAREDLA
Amgen
GIRIJAA KADAM
Sanofi
KRISHNA ASVALAYAN
PwC India
PRANAV SIKKA
Novartis
HARMONIZING PV REGULATIONS
16:10 – Discussion With Experts – Regulatory Evolution in Pharmacovigilance: Driving Compliance, Collaboration, & Innovation. Collaboration between Industry & Regulators to achieve safer drugs for patients’ safety.
Moderator
VIJAY KRISHNAN
Opella
Panellists
RAJENDRA KASI
Glenmark
NITU SINHA
Mankind Pharma
SRIRAM VARMA
TECHSOL
PADMA BALAKRISHNAN
Knowledgeworks Innovative Linguistic Solutions
AUDITS / INSPECTION
16:50 – Fire Side Chat - From CAPAs to Culture: Rethinking What Makes a Vendor Truly Reliable
- CAPA effectiveness matters more than CAPA closure.
- Quality culture is a stronger predictor of compliance than audit scores alone.
- Predictive oversight can identify vendor risks before they become inspection findings.
Speakers
ROHINI PANDEY
Abbott
VIVEK GUPTA
Organon
Our Partners
We sincerely thank the following organizations and individuals for generously contributing their time, financial support, ideas, and dedication toward the successful conduct of the 42nd pharmacovigilance india 2026
Principal Partner
Platinum Partner
Gold Partners
Silver Partners
Exhibitors
Networking Cocktail Partner
Startup Partners
Event Venue
Radisson Hyderabad Hitec City
MUMBAI
India
040 6769 6769
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Super Early Bird Price – 10,000 + GST – Valid until 30th Oct 2026
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Accommodation
We have secured special room rates for our conference participants who wish to stay at the conference venue hotel “Radisson” during the conference dates.
Once you confirm your participation, our operations team will share the room reservation details along with the booking deadline and the special rates we’ve arranged.
Event Testimonials
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Block 3, 86 Coombe Road
Croydon CR0 5RA
London, UK
Asia
Plot No – 07 – 2nd Floor
Ekambaram Industrial Estate
Alapakkam, Porur Chennai,
India – 600 116
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