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Biosimilars: Current Situation & Future Prospects, Worldwide Product Image

Biosimilars: Current Situation & Future Prospects, Worldwide

  • ID: 2077414
  • March 2012
  • Region: Global
  • 135 Pages
  • JustPharmaReports

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 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, where and with which biosimilars has most and least success been achieved, and why.

- Complexities of biological READ MORE >

Note: Product cover images may vary from those shown

Executive Summary

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

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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