16th Biosimilars Congregation 2021

09:20 - Welcome Address & Virtual Conference Platform Instructions

REGULATIONS FROM USFDA & EMA

09:30 – Overview of the regulatory considerations for Biosimilar product development
SWEETY MATHEW, Global Regulatory Affairs, Biocon

CHALLENGES & OPPORTUNITIES

10:00 – DISCUSSION WITH EXPERTS: Recent trends and new, normal in Biosimilars
• Most significant challenges in biosimilars for manufactures - vision for future and implementation of technology in production
• What is the new normal in Biosimilar? How to excel with this?
• Development challenges on the biosimilars products for companies? What are the remedies?
• New product targets for biosimilar development
• Pharmacovigilance and risk management of biosimilars.
• How is global biosimilar the player of fast-changing commercialised world?
• Key success factors in biosimilar policy
• Real World Evidence studies for Biosimilars
• Interchangeability and switch ability
• Regulatory audit approval – challenges and its management

Moderator:
NARENDRA MAHARAJ, Vice President and Head, Clinical Development and Biologics, Dr. Reddy’s Laboratories

Panellists:
SHALIGRAM RANE, Vice President of Quality, Lupin
PAWAN SINGH, Senior Medical Director, Biocon
NITISH CHAKRAVARTY, Vice President - Secondary Manufacturing, Biological E
ARUN BHATT, Consultant – Clinical Research & Development
NAGENDRA RAMANJINAPPA, Head Medical Affairs, Viatris
KAVYA KADAM, Consultant, Global Clinical Trials

REGULATORY

11:20 - DISCUSSION WITH EXPERTS: Analyzing the recent developments of regulatory in biosimilars.
• What are the recent developments in regulatory? How it is impacting the Pharma industry?
• Regulatory changes necessary to maximize biosimilars potential
• Regulators view on interchangeability and switching biosimilars.
• Legal hurdles to bring a biosimilar product to market
• What types of additional risk minimisation measures may be necessary?
• What are the developments we can expect in the next 5 years in the field of biosimilars regulations?

Moderator:
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates

Panellists:
RAHUL GUPTA, Vice President, Regulatory Affairs, USV
PRAVEEN KUMAR L, Director - Regulatory Affairs, Cipla
KUMAR GAURAV, Director Medical Affairs, Dr. Reddy’s Laboratories
HARSHAD KOTHAWADE, Head-Regulatory Management & Trade Compliance, Merck
MANISH MAHAJAN, DGM- Medical Affairs, Cadila Healthcare (BU- Biologics)
RAHUL CHAUHAN, Head - Regulatory Affairs, Taked

12:20 – GMP trends for Biosimilars & Way forward
PRAVIN KULKARNI, Vice President – Quality (Biotech), Wockhardt

12:50 - Networking luncheon

PRODUCT DEVELOPMENT

13:40 – DISCUSSION WITH EXPERTS: Discussing the hidden hurdles in product development in biosimilars.
• Next steps to evaluate the future opportunities for product development
• What are the potential strategic impacts on development? How does it work especially under pandemic times?
• Risk of adverse effects related to new drug development. How to overcome that?
• Newer versions of generic drugs truly increase the value of the market
• How to keep ensuring the balance between product development and patient safety? What are alternative ways that makes easier?
• Major and recent hurdles for healthcare providers in switching from reference products to biosimilars
• How to speed up the process of development and reduce costs of production?

Moderator:
PIRTHI PAL SINGH, Vice President, Tirupati Group

Panellists:
ARANI CHATTERJEE, Senior Vice President, Clinical Research, Aurobindo Pharma
SAMIR KULKARNI, Director, National Center for Nano-science and Nanotechnology
RAVI SHANKARA, Sr. GM (R & D) & Functional Head -Analytical, Development - Biologics and Peptides, Sun Pharma
KANTHIKIRAN VARANASI, Vice President and Head - Clinical Research & Operations, Galenicum
ALOK SHARMA, Head & GM, Quality Control, Lupin
PRAVIN A. NAIR, Head, Drug Product Development (R&D), Intas Pharmaceuticals (Biopharma Division)

INTERCHANGEABILITY

14:40 – Interchangeability of Biosimilar products
• What is interchangeability?
• US- FDA Approval of First Interchangeable Biosimilar: Mylan’s Insulin Semglee (insulin glargine-yfgn)
• Automatic substitution of this interchangeable Insulin will shift the Diabetes Market towards Biosimilars
• Learning from the US interchangeability for the Indian Market

MICHEL MIKHAIL, International Expert in Regulatory Affairs, Global Expert in Biosimilars (Germany)

15:10 – Afternoon Coffee/Tea

15:30 – The WHO SBP guideline revision: a chance to build, on experience to achieve a more efficient regulatory landscape
• The WHO is currently revising its Similar Biotherapeutics Products (i.e. biosimilar medicines) guideline.
• This important revision happens as discussions are intensifying worldwide on how to achieve regulatory streamlining.
• Among the necessary steps to reach regulatory streamlining, embracing regulatory science advances, increased international convergence among regulators, and a concerted global roadmap for implementation of clinical trial tailoring will be key.
• The input of biosimilar medicines manufacturers, provided through 2 rounds of public consultation on the new guideline draft, will be essential in ensuring fit-for-purpose guidance.

MARTA BALDRIGHI, Policy and Science Officer, Medicines for Europe (Belgium)

MARKET ACCESS & IMPLEMENTATION

16:00 – DISCUSSION WITH EXPERTS: Market Access - Key challenges and points for successful tomorrow market.
• What are the current trends affecting the biosimilar markets?
• Ways for smart handling of market access, sustainable pricing and reimbursement of biosimilars in the market.
• How to discover, estimate, and plan for entry opportunities?
• Addressing the challenges of market implementation in biosimilar.
• What are the ethical developments needed to make a better biosimilars market?
• Identifying the particular market barriers for biosimilar approval in India market.
• Sharing the knowledge towards policy implementation of biosimilar as driver in the market.

Moderator:
PHILIP SCHNEIDER, Chair, International Advisory Board, Alliance for Safe Biologic Medicines(USA)

Panellists:
ADITYA SHARMA, Head - BioProcessing Business, Merck Life Science
UDIT SAKHUJA, Head of Marketing, Dr. Reddy’s Laboratories
SAKHARAM GARALE, Founder & CEO, Renovare Healthcare Solutions
SONAL SHAH, Head Marketing – Biosimilars, Cadila
MAHENDRA SHIRADKAR, Lead: FDS Project and Portfolio Management, Viatris
TUSHAR NAIK, Consultant & Advisor, GLG(USA) (Former Senior GM, Zydus Group)

17:00 – End of the Conference