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Generics Reports

Biosimilars: Current Situation & Future Prospects, Worldwide

Buy This Report Now (Publication Date: March 2012)

Price: $2950 (single-user); $6450 (enterprise-wide license)

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The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this basis, prospects for biosimilars look good, with the vast majority of leading originator brands in the global biologics market expected to lose some degree of protection by 2019. All major countries now make provision for an abbreviated biosimilar development and regulatory pathway. Funds are flowing into the sector and many new partnership agreements have been signed. Everything in the biosimilar garden might look rosy, but what is the reality?

Biosimilar sales of $16+ billion were forecast in the EU and US alone for 2011.This estimate turned out to be 50-times too high. Does publication of the long-awaited guidance on the US Biologics Price Competition and Innovation Act mean a new dawn for biosimilars, or another false one?  Written with the understandable detail and objectivity you need, Biosimilars: Current Situation & Future Prospects, Worldwide provides the answers, including:

  • On the basis of several years market experience in Europe and Japan, which biosimilars have experienced greatest success and why
  • Analytical discussion of the complexities of biological patents
  • The big controversies with biosimilars explained: Sourcing of reference products, similarity, naming, interchangeability, immunogenicity, traceability, indication extrapolation
  • Where payers incentivize usage of biosimilars
  • The importance of devices to administer biosimilars.
  • Which companies are most active in biosimilar development, what are their targets and what is their developmental status
  • Where biosimilar prospects are brightest through 2016


This report is:

COMPREHENSIVE:  From patents/data exclusivity via development, manufacturing issues to regulatory requirements, pricing and reimbursement demands, funding provisions and beyond to the realities of the market – it’s all here

GLOBAL: The situation in 27 developed and developing countries - across Europe, the Americas, Asia-Pacific and the Indian subcontinent

UP-TO-DATE: Includes 2011 sales data and February 2012 proposed FDA guidance

FACT-FILLED: Over 60 tables

 

TABLE OF CONTENTS

1. Introduction
     Biosimilarity
     Rationale for biosimilars
     Regulatory guidelines
     Types of biosimilars
     Lack of standardisation
     Market situation

2. Safety Concerns
    Issues with biosimilars
    Issues with originator products
    Immunogenicity
    Exchangeability
    Traceability
    Nomenclature
    Scare stories

3. Regulatory Developments in Europe
    Biosimilar pathway
    Regulatory guidelines
    Risk management plans
    Regulatory approvals
    Other products
    Withdrawals
    Intellectual property protection
    Prescribing and substitution
    Hospital market and tendering

4. Market Access Situation in Europe
    Launches
    Sales
    Market opportunity
    Product-specific features
    Country-specific features
    Savings
    National situation
         Bulgaria  
         Denmark
         France
         Germany
         Hungary
         Italy
         Netherlands
         Norway
         Poland
         Spain
         Sweden
         UK
    Leading biosimilar companies in Europe
    
5. North America
    US
         BPCIA pathway
         Interchangeability
         Regulatory exclusivity
         Patent information exchange
         Debate
         Forecast usage and savings
         Guidance from FDA
             Preliminary guidance
             February 2012 guidance
         Review goals and user fees
         Market situation
    Canada
         Intellectual property protection
         Subsequent entry biologic pathway
         Pricing and reimbursement
         Interchangeability

6. Asia-Pacific
    Japan
         Regulatory guidelines
         Intellectual property protection
         Market situation
         Interchangeability
         Pricing and reimbursement
         Sales
    Korea
         Biosimilar companies
         Regulatory guidelines
         Intellectual property protection
         Pricing and reimbursement
    Australia
    Taiwan
    Malaysia
    New Zealand
    Singapore

7. Emerging Markets
    Brazil
    China
    India
    Mexico
    Russia
    Turkey

8. Biobetters
    What makes a biobetter?
    Examples
         Re-engineered glycosylation pattern
         Pegylation

9. Future Biosimilar Product Opportunities
    Insulins
    Interferon alfa
    Monoclonal antibodies
    Orphan drugs

10. Future Biosimilar Market Opportunities
    Europe
    US
    Japan
    Korea
    Emerging markets

11. Biosimilar Challenges
    Intellectual property challenges
         EU
         US
         Etanercept case study
         Trans Pacific Partnership
    Partnership challenges
    Development challenges
    Manufacturing challenges
    Device challenges
    Marketing challenges
    HTA challenges
    Indication extrapolation challenges
    Competitive intelligence challenges
    Post-marketing challenges

12. Forecast
    New biosimilar dawn or another false dawn?
    Opportunities
    Threats
    Conclusions

List of Tables

How biosimilars differ from generics
Biosimilars vs novel biologics, probability to next development phase
Pharmacodynamic markers for efficacy in biosimilarity
Marketed originator EPO, hGH and G-CSF brands in EU
Global biosimilar sales, 2007-10
Global biosimilar sales by country, 2010
Global biosimilar sales by brand, 2010
Global biosimilar sales by company, 2010
Benefits and problems related to use of biosimilars
Immunogenicity potential of selected biologics
Frequency of antibody formation; biosimilars and reference products
Sandoz’ principles for science-based biosimilar approval and fair market access
Biosimilar approvals in EU
Evidence generated for approval of selected biosimilars
Biosimilar launch quarters across Europe
EMA approval and market entry dates; originators & biosimilars
Launch status for biosimilar filgrastim by brand
Launch status for biosimilar epoetin by brand
Launch status for biosimilar somatropin by brand
European sales of biosimilars and reference products, 2007-09
Biosimilar share of reference biologic sales in Europe, 2011
European biosimilar penetration of therapeutic classes, 2011
Biosimilar value share of classes by European country, 2011
Market access procedures across EU with biosimilars
Average list price savings from biosimilars in Europe, 2007-09
List prices for Neupogen and its biosimilars in Europe by country
Average list price saving from biosimilar epoetin and somatropin
Sales and market penetration of biosimilars in France, 2010
Costs of anaemia treatment with epoetins in Germany, 2010
Public prices of somatropin brands in Germany
Public prices of parallel-imported somatropins in Germany
Reference prices for short-acting epoetins in Germany  
Price reductions required from launch with biosimilars in Italy
Savings realised with biologics by hospital tenders in Norway
Evolution of filgrastim market shares in Sweden, 2009-10
NHS indicative prices for originators, biosimilars in UK
Performance of biosimilar companies in Europe
Follow-on biologics approved in US under ANDA or section 505(b)(2) pathway
Japanese reimbursement prices of biosimilars and reference drugs
Celltrion’s mAb product launch schedule in Korea
Costs of biosimilar development in emerging markets
Price of originator biologics in emerging markets as % of US price
Biosimilars manufactured in India
Evolution of application and dosing with TNF-alfa inhibitors
Opportunities for product enhancement with pegylation
Marketed pegylated proteins
Global sales on monoclonal antibodies, 2010
Biosimilar rituximabs in development
Approved indications for selected anti-TNFs in US
Korean biosimilar sales projections, 2016
Emerging market biosimilar sales forecast for 2016 by country
Emerging market biosimilar sales forecast for 2016 by molecule
Rating of competencies for developing/marketing biosimilars
Molecular complexity of actual and potential biosimilars
Biotech-biosimilar business model

Appendices
    Estimated patent expiries of selected biologics in US, EU & Japan
    Biosimilar sales projections for 2016 in emerging markets, by country/molecule
Glossary of Abbreviations and Acronyms
References

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