20th Biosimilars Congregation 2025
20th Biosimilars Congregation 2025
11 December, 2025
Kohinoor Continental Hotel, Mumbai, India
5 Reasons to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminating travel hassles while accessing high-quality content at your own pace.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
An Agenda Made For You
High quality content that addresses your biggest challenges and uncovering hidden opportunities.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Key Focus Areas
Regulatory Updates & Policy Shifts
Market Access, Pricing & Affordability Strategies
Cost Competitiveness vs. Global Players
Scaling Manufacturing / Development / Commercialisation
Export Growth & Global Market Alignment
Next-Gen Biosimilars & Technological Innovation
Role & Expectations of Payers
Patent Landscape & IP Navigation in India
Real-World Evidence (RWE) & PMS in India
Patient Awareness & Education Initiatives
Physician Trust & Clinical Confidence Building
Quality Standards & Biosimilar Pharmacovigilance
Digital Tools in Biosimilar R&D and Process Monitoring
What’s the way forward? / Opportunity – Learn & Network
Event Speakers
Download Brochure
Event Schedule
Meet to learn and network with your conference colleagues.
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 – Biologics vs Biosimilars: Clinical Development
CLINICAL DEVELOPMENT
- Standalone vs abbreviated regulatory path
- Challenges in development of biosimilars
- Strategies to be adopted in development of biosimilars
- Concept and regulations around interchangebility, extrapolation of data etc
Speaker
HANMANT BARKATE
Group VP & Global Head – Medical Affairs
Glenmark
10:00 – KEYNOTE PANEL DISCUSSION: Breaking Barriers: Access, Strategy & Growth in the Biosimilar Era
TRENDS & STRATERGIES
- Current state and growth trajectory of the Indian biosimilar market
- Strategies to enhance market access in tier-2 and tier-3 cities
- Addressing pricing pressures while maintaining profitability and quality
- Building prescriber and patient confidence in biosimilar adoption
- Leveraging public procurement and tendering systems for wider reach
- Overcoming manufacturing and supply chain hurdles within India
- Collaborative models between domestic players and global partners
- Process controls and quality compliance in manufacturing
- Future opportunities for Indian biosimilar exports and global competitiveness
Moderator
OMPRAKASH S. SADHWANI
Former Joint Commissioner and controlling Authority
FDA (Maharashtra State)
Panellists
SANJEEV GUPTA
Sr. Vice President & Head Biosimilar
Ipca Laboratories
MANNAN KHAMBATI
VP Biotech Manufacturing
Bharat Serums and Vaccines
SUMITA MOHAPATRO PANI
Sr. VP & Head – Business Development &
Inlicensing , Business Ethics & Compliance
Lupin
AMARNATH CHATTERJEE
Director & Head Analytical Sciences & QC
Cipla
RAVI SAILAPPAN
Head – EPD Quality Systems
Abbott
11:00 – Morning Coffee/Tea & Discussion
11:30 – Strengthen the foundations by enhancing the R&D operating model
R&D
- R&D approach towards process development while ensuring product quality.
- Scale-up and the necessary Intra-organizational Communication (R&D to Manufacturing)
- R&D strategies for an event-free manufacturing operation
- Real-Life Case-studies
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:00 - Topic TBC
For sponsorship opportunities please contact info@virtueinsight.com
12:30 – Networking luncheon
13:30 – PANEL DISCUSSION WITH EXPERTS - Beyond the Trial: RWE as the New Benchmark for Biosimilar Approval
RWE
- Current role of RWE in biosimilar approvals in India and globally
- How RWE can complement clinical trial data for establishing biosimilarity
- RWD sources in India: EHRs, registries, hospital networks, and challenges in data collection
- Leveraging RWE to support interchangeability and substitution decisions
- RWE’s role in building prescriber and patient confidence in biosimilars
- Industry readiness for generating high-quality, regulatory-grade RWE
- Collaborative approaches between regulators, industry, and healthcare providers for RWE generation
- Future outlook: Can RWE reduce the need for large-scale comparative clinical trials in India?
Moderator
KAVITA LAMROR
Partner, RWE & Digital Transformation
Maxis Clinical Sciences
Panellists
SANTOSH TAUR
Director Medical Affairs, Vaccines, Rare Diseases & Digital
Pfizer
SOURABH FULMALI
Global Medical Director
GSK
VIKAS VAISHNAVI
Director, Program Patient Safety
Sandoz
SONALI KHANRA
Associate Director, RWE
Novartis
AMARNATH SUGUMARAN
Associate Director & Cluster Head Medical Affairs
Cipla
MAYUR MAYBHATE
Head Medical Affairs
Alkem Laboratories
14:20 – An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare” including the following points of discussion
MANUFACTURING
- Development and Regulatory Approval of Biosimilars
- Post-Marketing Monitoring of Safety of Biosimilars—Pharmacovigilance
- Controversies / Challenges in the Use of Biosimilars
Speaker
APARNA PRABHUNE
Deputy GM – Regulatory Affairs
Wockhardt
14:50 – Afternoon Tea/Coffee
15:10 – PANEL DISCUSSION WITH EXPERTS - Fast Track to Market – Strategies for Balancing Access, Timing & Exclusivity
MARKET ACCESS
- Strategies to minimize time from approval to product launch
- Market exclusivity norms in India and how they impact first-to-market advantage
- Overcoming legal and IP challenges that delay market entry
- Understanding how product launches are influenced
- Optimizing manufacturing readiness and supply chain alignment pre-launch
- Commercial strategies to capture early market share post-launch
- Balancing speed with compliance and long-term market sustainability
- Key regulatory pathways in India for faster biosimilar approvals
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
DEBASHIS SARKAR
Senior VP & Head Emerging Markets
Aurobindo
SANJAY B NIRANJAN
Assistant Director, Bioassay Development (Biosimilars)
Lupin
SEEMA BHANDARKAR
Commercial Head CIS & Russia Biosimilars
Biocon
KHUSHBOO PANCHAL
Business Strategy Manager – Asia Pacific Region
MSD
16:00 – PANEL DISCUSSION WITH EXPERTS - Next- Gen Regulation: India’s Roadmap for Biosimilar Approvals
REGULATORY
- Overview of current CDSCO guidelines and recent updates for biosimilar approvals
- Scope and clarity around interchangeability and extrapolation of indications
- Reducing timelines for approvals without compromising safety and efficacy
- Challenges faced by developers in meeting regulatory expectations
- Role of Phase IV studies and post-marketing surveillance in Indian approvals
- Importance of regulatory harmonisation for export and global competitiveness
- Opportunities for digital tools and data integration in regulatory submissions
- Industry feedback mechanisms and engagement with regulatory authorities
- What’s next? Ways to proceed forward
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
ABHISHEK SINHA
VP Global Regulatory Affairs
Advanz Pharma
AKSHAYA ODAK
Head – Regulatory Affairs (Biotech)
Lupin
KHOKAN DEBNATH
Sr GM / (Head) – Regulatory Affairs, ClinicalOperations, PV, QA & Compliance (India & Emerging Market),
Wockhardt
SHUVANKAR BALLAV
Head, Regulatory Affairs – Advanced Biotech Lab (ABL)
Ipca Laboratories
SWEETY MATTHEW
Regulatory Professional- Global Regulatory Affairs: CMC Rare Diseases
Novo Nordisk
17:00 – Lucky Draw Gifts/Closing Remarks & End of conference
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 – Biologics vs Biosimilars: Clinical Development
CLINICAL DEVELOPMENT
- Standalone vs abbreviated regulatory path
- Challenges in development of biosimilars
- Strategies to be adopted in development of biosimilars
- Concept and regulations around interchangebility, extrapolation of data etc
Speaker
HANMANT BARKATE
Group VP & Global Head – Medical Affairs
Glenmark
10:00 – KEYNOTE PANEL DISCUSSION: Breaking Barriers: Access, Strategy & Growth in the Biosimilar Era
TRENDS & STRATERGIES
- Current state and growth trajectory of the Indian biosimilar market
- Strategies to enhance market access in tier-2 and tier-3 cities
- Addressing pricing pressures while maintaining profitability and quality
- Building prescriber and patient confidence in biosimilar adoption
- Leveraging public procurement and tendering systems for wider reach
- Overcoming manufacturing and supply chain hurdles within India
- Collaborative models between domestic players and global partners
- Process controls and quality compliance in manufacturing
- Future opportunities for Indian biosimilar exports and global competitiveness
Moderator
OMPRAKASH S. SADHWANI
Former Joint Commissioner and controlling Authority
FDA (Maharashtra State)
Panellists
SANJEEV GUPTA
Sr. Vice President & Head Biosimilar
Ipca Laboratories
MANNAN KHAMBATI
VP Biotech Manufacturing
Bharat Serums and Vaccines
SUMITA MOHAPATRO PANI
Sr. VP & Head – Business Development &
Inlicensing , Business Ethics & Compliance
Lupin
AMARNATH CHATTERJEE
Director & Head Analytical Sciences & QC
Cipla
RAVI SAILAPPAN
Head – EPD Quality Systems
Abbott
11:00 – Morning Coffee/Tea & Discussion
11:30 – Strengthen the foundations by enhancing the R&D operating model
R&D
- R&D approach towards process development while ensuring product quality.
- Scale-up and the necessary Intra-organizational Communication (R&D to Manufacturing)
- R&D strategies for an event-free manufacturing operation
- Real-Life Case-studies
Speaker
SAMIR KULKARNI
Head – DBT ICT Center
Institute of Chemical Technology
12:00 - Topic TBC
For sponsorship opportunities please contact info@virtueinsight.com
12:30 – Networking luncheon
13:30 – PANEL DISCUSSION WITH EXPERTS - Beyond the Trial: RWE as the New Benchmark for Biosimilar Approval
RWE
- Current role of RWE in biosimilar approvals in India and globally
- How RWE can complement clinical trial data for establishing biosimilarity
- RWD sources in India: EHRs, registries, hospital networks, and challenges in data collection
- Leveraging RWE to support interchangeability and substitution decisions
- RWE’s role in building prescriber and patient confidence in biosimilars
- Industry readiness for generating high-quality, regulatory-grade RWE
- Collaborative approaches between regulators, industry, and healthcare providers for RWE generation
- Future outlook: Can RWE reduce the need for large-scale comparative clinical trials in India?
Moderator
KAVITA LAMROR
Partner, RWE & Digital Transformation
Maxis Clinical Sciences
Panellists
SANTOSH TAUR
Director Medical Affairs, Vaccines, Rare Diseases & Digital
Pfizer
SOURABH FULMALI
Global Medical Director
GSK
VIKAS VAISHNAVI
Director, Program Patient Safety
Sandoz
SONALI KHANRA
Associate Director, RWE
Novartis
AMARNATH SUGUMARAN
Associate Director & Cluster Head Medical Affairs
Cipla
MAYUR MAYBHATE
Head Medical Affairs
Alkem Laboratories
14:20 – An Overview of Biosimilars—Development, Quality, Regulatory Issues, and Management in Healthcare” including the following points of discussion
MANUFACTURING
- Development and Regulatory Approval of Biosimilars
- Post-Marketing Monitoring of Safety of Biosimilars—Pharmacovigilance
- Controversies / Challenges in the Use of Biosimilars
Speaker
APARNA PRABHUNE
Deputy GM – Regulatory Affairs
Wockhardt
14:50 – Afternoon Tea/Coffee
15:10 – PANEL DISCUSSION WITH EXPERTS - Fast Track to Market – Strategies for Balancing Access, Timing & Exclusivity
MARKET ACCESS
- Strategies to minimize time from approval to product launch
- Market exclusivity norms in India and how they impact first-to-market advantage
- Overcoming legal and IP challenges that delay market entry
- Understanding how product launches are influenced
- Optimizing manufacturing readiness and supply chain alignment pre-launch
- Commercial strategies to capture early market share post-launch
- Balancing speed with compliance and long-term market sustainability
- Key regulatory pathways in India for faster biosimilar approvals
Moderator
VISHWAS SOVANI
Founder Director
Pharmawisdom
Panellists
DEBASHIS SARKAR
Senior VP & Head Emerging Markets
Aurobindo
SANJAY B NIRANJAN
Assistant Director, Bioassay Development (Biosimilars)
Lupin
SEEMA BHANDARKAR
Commercial Head CIS & Russia Biosimilars
Biocon
KHUSHBOO PANCHAL
Business Strategy Manager – Asia Pacific Region
MSD
16:00 – PANEL DISCUSSION WITH EXPERTS - Next- Gen Regulation: India’s Roadmap for Biosimilar Approvals
REGULATORY
- Overview of current CDSCO guidelines and recent updates for biosimilar approvals
- Scope and clarity around interchangeability and extrapolation of indications
- Reducing timelines for approvals without compromising safety and efficacy
- Challenges faced by developers in meeting regulatory expectations
- Role of Phase IV studies and post-marketing surveillance in Indian approvals
- Importance of regulatory harmonisation for export and global competitiveness
- Opportunities for digital tools and data integration in regulatory submissions
- Industry feedback mechanisms and engagement with regulatory authorities
- What’s next? Ways to proceed forward
Moderator
MILIND ANTANI
Leader, Pharma & Healthcare
Nishith Desai Associates
Panellists
ABHISHEK SINHA
VP Global Regulatory Affairs
Advanz Pharma
AKSHAYA ODAK
Head – Regulatory Affairs (Biotech)
Lupin
KHOKAN DEBNATH
Sr GM / (Head) – Regulatory Affairs, ClinicalOperations, PV, QA & Compliance (India & Emerging Market),
Wockhardt
SHUVANKAR BALLAV
Head, Regulatory Affairs – Advanced Biotech Lab (ABL)
Ipca Laboratories
SWEETY MATTHEW
Regulatory Professional- Global Regulatory Affairs: CMC Rare Diseases
Novo Nordisk
17:00 – Lucky Draw Gifts/Closing Remarks & End of conference
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Event Sponsors
We wouldn’t be able to host our conferences without help from these amazing companies. A huge thanks to all our sponsors and partners!
Exhibitor
Conceptualized By
- Phone:+91 44 42108101
- Email:info@virtueinsight.com
Supported By
Event Testimonials
A huge thanks to all our sponsors, attendees and partners!
“This conference was helpful to understand about biosimilars products, clinical studies to be conducted. Challenges and best practices that can be adopted for biosimilars products.”
Overall it was a very knowledgeable session. Very engaging and touched almost all the aspects of biosimilars drugs spanning from old history to current development.
Conference was very good and knowledgeable. It gave us insights on biosimilars products. It also informed us challenges and benefits of biosimilar products/future aspects of the same and current status.
Conference was very helpful and helps to understand more insights regarding biosimilars. Got more insights on current industry challenges of biosimilars and also helps to understand further scope of improvement in terms of regulations and guidelines.
This conference was helpful to understand about biosimilars products, clinical studies to be conducted. Challenges and best practices that can be adopted for biosimilars products.
Excellent conference for knowledge gaining and networking. Very Useful
Great event covering all aspects of Biosimilars from development, regulatory, market access and challenges. Overall a great platform to hear from the experts in the field.
Great conference and Good networking
The Conference has been really informative and the presenters were experts in their areas. Overall, benefitted from the conference.
Dual The event was well organized and a good combination of some interesting speakers and great networking opportunity amongst the companies. I am thankful for having the opportunity to attend.
The session was icebreaker for commercial person from business development side. Interesting facts were unveiled and understood. Very well organized and topics covered
Good Knowledge sharing, speakers are provided every aspects of Biosimilars development. Overall was good collaboration in this conference.
It was a good platform to connect with SMEs from the industry and academics. Had a good networking.
Over all Very Good & excellent. Enjoyed all session
The Majority o the topics covered within conference focus are current and intereting to earn new things. It’s value for money and time spent.
You covered a lot of areas in Biosimilars arena. The session both individual talks and panel discussions we well distributf during the day and wel conducted. In future you can consider conducting of 2day conference.
Very Insightful and knowledgeable. Thought provoking
Attended first time. It was very informative and provided good insight into understanding of regulatory landscape in India and Biologics Industry positioning.
Thanks team Virtue Insight for the invitation! It was a very interactive meeting. Thoroughly enjoyed being part of it.!
Thank you Virtue Insights for the opportunity to exhibit and being in an esteemed panel. It was truly amazing gathering of Key opinion Leaders from Biosimilar Industry.
A commendable effort from the team of Virtue Insights! Mutually rewarding
It was indeed a good panel discussion... Virtue Insights Thanks for the opportunity... Looking forward to more such insightful discussions and sharing!!
It was very good knowledge sharing platform.
It was good platform for discussing key issues and concerns on developing biosimilars
It was really informative and knowledge sharing. Great networking platform
The 12th congregation was well organized with a variety of topics that ensure that the attendees were exposed to various aspects of biosimilars from manufacturing to implementation in various health systems
Well organised
Great, well organised conference. Good, relevant topics from the speakers. Thank you for a great event.
Good Discussions, Thank you Very Much
Good use of two screen technology and warm welcome and induction at registration
Pricing Details
SUPER EARLY BIRD PRICE — INR 11,000 + GST (18%) PER DELEGATE (Until 31 OCT 2025)
You can simply email or call and book your conference delegate seats on:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
CONFERENCE SPONSOR & EXHIBITION STALL
Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
Download Brochure
Venue Details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
Kohinoor Continental Hotel, Mumbai,
India
Andheri Kurla Road, Andheri ( E ),
Mumbai 400059 – India
91 22 66919000 / 91 22 28209999
Venue
Kohinoor Continental Hotel
Andheri Kurla Road, Andheri ( E ), Mumbai 400059 – India
91 22 66919000 / 91 22 28209999





