Programme

Day One Wednesday 10 September 2008

Registration

Opening remarks from the Chair

The need for biosimilars - a developing country's perspective

• Ascertaining the regulatory pathway - the unknowns and ever-changing dynamics of the processes and differences across nations
• Position of biosimilar manufacturers in India
• Challenges of developing a biosimilar - touching on the economics of the business
• Launching a biosimilar - is it worth it?

Examining opportunities and challenges for biosimilars in Europe

• What are the challenges for market entry into the EU?
• How do the USA and EU compare?
• What are the hurdles for biosimilar manufacturers?
• What are the data requirements for developing a biosimilar in the EU?
• Discussing more complex proteins e.g. blood products and monoclonals
• Lessons learned from biosimilars recently approved in the EU

Morning refreshments

Examining the importance of biosimilars and overcoming barriers in their development

• Discussing why biosimilars are crucial for the industry
• Examining how legal bodies should help us find solutions and not hinder the process
• Overcoming barriers built by innovators to protect their business
• The importance of substitution and interchangeability
• Overall portfolio and marketing approach

Business strategy – considering the costs of developing biogenerics

• Increased costs arising from the increased time needed for the production and clinical testing of biosimilars
• Considering the stricter safety controls needed for biosimilars over conventional medicines or original biotech products
• The importance of concentrating on drugs with improved efficiency
• Increasing the diversity of the biosimilar market – the expectation of future launches

Lunch

Examining the opportunities in biosimilars development

• Overview of the Reliance Life Sciences and its position on the biosimilars market
• Biosimilars strategy and pipeline
• Evaluating prospective business opportunities - strategic alliances and partnerships in research, manufacturing and marketing

Assessing the IP implications

• Clarifying the IP implications of launching a biosimilar product
• Practical examples of patent infringements
• Developing a non-infringing product to speed time to market

Biosimilars – current regulatory issues and challenges

• Biosimilars pose some unique regulatory challenges
• Accurate pharmacovigilance - will existing pharmacovigilance systems be adequate?
• Interchangeability and automatic substitution - should rules designed for small molecule generics apply to biologicals?
  
• Information for healthcare providers - what information should be provided to ensure safe and efficacious use of biosimilars?
• Issues from the recent biosimilar approvals

Regulatory asset or hazard – case study on Alpheon

• Challenges in developing a biosimilar / follow-on biologics
• Understanding stringent European requirements for demonstrating biosimilarity
• Demonstrating comparability on quality, nonclinical, and clinical stages which opens the door for general “risks” in drug development
• Preventing asset from turning into a hazard

Challenges in the development of biosimilar product(s) that meet global regulatory requirement

• Development of a biosimilar product that does not infringe upon an innovator’s process
• Characterization of product and product-related impurities
• Demonstrating the comparability of biopharmaceuticals
• Implementation of systems that meets regulatory requirements
• Risk assessment

Closing remarks from the Chair and close of Day One

Day Two Thursday 11 September 2008

Registration

Opening remarks from the Chair

Roundtable 1
Strategic and tactical considerations for the development of biosimilars

Murali Tummuru
CEO
VIRCHOW BIOTECH

Roundtable 2
Overcoming prescriber and patient perceptions of a biosimilar

Roundtable 3
Challenges and opportunities for generics companies

Roundtable 4
Parameters for comparing a biosimilar with the originator product to establish safety

Roundtable 5
The impact of biosimilars on originators of biological drugs

Lunch

Development of G-CSF biosimilar - a win-win-win situation on three continents

• Developing and marketing biosimilars in Europe
• The need for extensive experience in regulatory and commercial strategies
• collaborating with non-European pharmaceutical companies as a part of a new business strategy
• G-CSF development case study - involvement of players from three continents (Europe/Canada/India)

Implications of the heterogeneity of biosimilar medicinal products

• Ongoing debate on the similarity and efficiency of biosimilar drugs
• The impact of biosimilars heterogeneity on regulatory approval
• Quantifying the difference - establishing the parameters for comparability
• Changes in the composition and its effect on drug comparison and efficacy

Ensuring patient safety and clinical efficacy

• Understanding the regulatory framework for safeguarding patients
• Parameters for comparing a biosimilar with an originator product to establish safety
• Difficulties with clinical trials recruitment
• Guaranteeing that proposed clinical trials programmes don’t put patients at risk
• Successfully introducing biosimilar drugs into clinical practice

Preclinical immunogenicity screening of biosimilars

• Factors driving the immunogenicity of biotherapeutics
• Regulatory framework for immunogenicity assessment of biotherapeutics
• Preclinical strategies to accurately compare immunogenicity

Effective biological assay systems for biosimilars

• Examining different approaches to bioassay design and application
• Discussing the degree of testing needed
• Effectively establishing potency and comparability with the innovator product
• Encouraging R&D investment in the development of interchangeable biosimilars

Closing remarks from the Chair and end of the conference