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Biosimilars: Current Situation & Future Prospects, Worldwide

Published By :

JustPharmaReports.com

Published Date : Mar 2012

Category :

Biomarkers

No. of Pages : 135 Pages


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 patents.
  • The big controversies with biosimilars explained: Sourcing of reference products, similarity, naming, interchangeability, immunogenicity, traceability, indication extrapolation.
  • Where payers incentivise usage of biosimilars.
  • The importance of devices to administer biosimilars.
  • Which companies are most active in biosimilar development, what are their targets and how far have they reached.
  • Where biosimilar prospects are brightest through 2016
  • 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 Content

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 Table


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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