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20th Biosimilars Congregation 2025

20th Biosimilars Congregation 2025

11 December, 2025

Kohinoor Continental Hotel, Mumbai, India

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    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

    DEBASHIS S

    Aurobindo

    SANJEEV GUPTA

    Ipca Laboratories

    SUMITA M P

    Lupin

    HANMANT B

    Glenmark

    ABHISHEK SINHA

    Advanz Pharma

    MANNAN K

    Bharat Serums and Vaccines

    VIKAS VAISHNAVI

    Sandoz

    MILIND ANTANI

    Nishith Desai Associates

    OMPRAKASH S. S

    FDA (Former)

    SONALI KHANRA

    Novartis

    AMARNATH S

    Cipla

    SANTOSH TAUR

    Pfizer

    AMARNATH C

    Cipla

    SOURABH F

    GSK

    RAVI SAILAPPAN

    Abbott

    SANJAY B N

    Lupin

    SHUVANKAR B

    Ipca Laboratories

    SAMIR KULKARNI

    Institute of Chemical Technology

    AKSHAYA ODAK

    Lupin

    SWEETY M

    Novo Nordisk

    SEEMA B

    Biocon

    APARNA P

    Wockhardt

    MAYUR M

    Alkem Laboratories

    KAVITA LAMROR

    Maxis Clinical Sciences

    KHOKAN D

    Wockhardt

    KHUSHBOO P

    MSD

    VISHWAS S

    Pharmawisdom

    Book Now
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    Download Brochure

      Event Schedule

      Meet to learn and network with your conference colleagues.

      11th December
      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
      Book Now
      ×

      Download Brochure

        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 

        Virtue Insight was founded in 2009. We equip business professionals around the world with the latest in-depth industry knowledge and provide networking opportunities in telecom, technology and pharmaceutical industries. Our aim is to provide a platform to share knowledge, insight and provide our clients to network effectively and deliver maximum ROl by making new business alliances.
        • Phone:+91 44 42108101
        • Email:info@virtueinsight.com

        Supported By 

        All Conference Alert is the world’s leading information portal for the upcoming Conferences, Events, Seminars, Expo, Webinars & Workshops. All Conference Alert helps professionals and enthusiasts to attain international conferences, communicate and collaborate with scientists, research scholars, and industry leaders from various regions and capacities. This platform helps both organizers and participants.

        Event Testimonials

        A huge thanks to all our sponsors, attendees and partners!

        Insightful Session

        “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.”

        Cognizant Team Manager
        Great Event

        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.

        Sr. Manager (Group Lead), Zydus Lifesciences
        Great Event

        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.

        Service Delivery Manager, Cognizant
        Insightful Session

        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.

        Team Manager, Cognizant

        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.

        Team Manager, Cognizant

        Excellent conference for knowledge gaining and networking. Very Useful

        Consultant, Sidvim LifeSciences

        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.

        Business Manager, Biotage

        Great conference and Good networking

        Director, USP India

        The Conference has been really informative and the presenters were experts in their areas. Overall, benefitted from the conference.

        Director Pharmacovigilance, Clarivate

        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.

        GM - Technical Sales and Marketing (South region), Gangwal Chemicals

        The session was icebreaker for commercial person from business development side. Interesting facts were unveiled and understood. Very well organized and topics covered

        Business Development, Intas Pharma

        Good Knowledge sharing, speakers are provided every aspects of Biosimilars development. Overall was good collaboration in this conference.

        Manager – Compliance, Biocon Biologics

        It was a good platform to connect with SMEs from the industry and academics. Had a good networking.

        BD Manager, Lupin

        Over all Very Good  & excellent.  Enjoyed all session

        Vice President, Lupin

        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.

        AGM, Intas /Accord Pharma

        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.

        Asst. Director, Lupin

        Very Insightful and knowledgeable. Thought provoking

        AGM, IPCA Labs

        Attended first time. It was very informative and provided good insight into understanding of regulatory landscape in India and Biologics Industry positioning.

        – Lead Investigator, Syngene International

        Thanks team Virtue Insight for the invitation! It was a very interactive meeting. Thoroughly enjoyed being part of it.!

        Vice President, Medical, Clinical & Regulatory Affairs, India Business & ROW, Wockhardt

        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.

        Founder & Chief Executive Officer, Nucleon Therapeutics

        A commendable effort from the team of Virtue Insights! Mutually rewarding

        Head- Medical Affairs, Cadila Healthcare

        It was indeed a good panel discussion... Virtue Insights Thanks for the opportunity... Looking forward to more such insightful discussions and sharing!!

        Founder & CEO, ENERGYA - RSG Nutrition & Healthcare

        It was very good knowledge sharing platform.

        Deputy Collector, Government Of Gujarat

        It was good platform for discussing key issues and concerns on developing biosimilars

        Team lead, Ideation, Medical Affairs, Dr. Reddy's Laboratories

        It was really informative and knowledge sharing. Great networking platform

        Editor, IJDRA Journal

        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

        Sr. Global Brand Medical Director - Global Medical Affairs, Takeda

        Well organised

        Executive Secretary, European Specialist Nurses Organisations (ESNO)

        Great, well organised conference. Good, relevant topics from the speakers. Thank you for a great event.

        Global Director, GE Healthcare

        Good Discussions, Thank you Very Much

        COO, VelaLabs GmbH

        Good use of two screen technology and warm welcome and induction at registration

        International Advisory Board Member, Biosimilars Spokesperson, Alliance for Safe Biologic Medicines

          Pricing Details

           SUPER EARLY BIRD  PRICE — INR 11,000 + GST (18%) PER DELEGATE (Until 31 OCT 2025)

          STANDARD PRICE — INR 16,000 + GST (18%) PER DELEGATE

          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

            Book Now

            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

            Get Involved

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            fen@virtueinsightevents.com
            +91 44 42108101
            Sponsorship & Delegate Sales

            Sponsorship & Delegate Enquiry

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            piyush@virtueinsightevents.com
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            39<span>th</span> Pharmacovigilance India 2025

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            17<span>th</span> Annual Pharma Anti-Counterfeiting, Serialization & Supply Chain Security 2026

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