There is great demand for lower-cost biological drugs: commercial and regulatory developments will make biosimilars and follow-on biologics a success – our new report explains how

Revenues for biologic drugs reached approximately $125bn in 2008. Patents on most current biologics have expired or will expire during the period 2009 to 2024. In addition, there is mounting pressure from governments, insurers and patients’ groups to reduce costs of pharmaceuticals. Biologic drugs - noted as some of the most-expensive medicines - are major targets for cost savings. The developments facilitating follow-on biologics are gaining momentum, with significant commercial opportunities emerging - as our new report explains.

Recently Merck & Co. established a new biosimilar (follow-on biologic or biogeneric) development division; other major pharmaceutical companies plan to follow suit. In March 2009, three new bills on follow-on biologic legislation were introduced to the US Congress. Biosimilars are entering an important period of development. Is your company prepared for the opportunities and threats this will create? The new visiongain report - Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024 - provides you with essential information to understand this rapidly-emerging market.

This report predicts how the biosimilar market will evolve from 2009 to 2024. We indentify and discuss the biosimilar drugs and manufacturers that will achieve commercial success during the coming fifteen years. Biologic drug classes covered in this report include:

• Growth hormones
• Insulin
• Erythropoietin
• Colony stimulating factors and interleukin-2 drugs
• Interferons
• Monoclonal antibodies
• Fusion proteins

The biosimilar prospects for each class are examined, biosimilar targets identified and market forecasts to 2024 provided, with extensive supporting information.

Comprehensive analysis of the global market

Using a wealth of research – including detailed sales forecasting, interviews with key opinion leaders and examination of policy documents, reports, industry news, filings and commercial databases – our new study forecasts how the biosimilar market will progress from 2009 to 2024.

Why you should buy Biosimilars and Follow-On Biologics: The Global Outlook 2009-2024

By obtaining your copy of this report, you will benefit from:
• Forecasts for the world biosimilar market, leading biosimilar drug types and leading national markets
• Identification of biologic drugs with potential for commercial biosimilar development
• Original interviews with biosimilar industry experts, who discuss the present and future of the sector
• Examination of the driving forces, restraints, competition and opportunities facing commercial stakeholders in the biologic and biosimilar sectors
• Analysis of biosimilar legislation and regulatory guidance in the US, Europe and Japan – with current and emerging trends discussed
• Analysis of the biosimilar pipeline – find out what and who will be the leading biosimilar players over the next fifteen years
• Prediction of where the market is heading - both technologically and commercially - from the present onwards.

The complexity of biologic drugs has retarded development of regulatory frameworks for approval of biosimilars in many countries. The EU was the first major regulatory authority to adopt a procedure allowing regulatory approval of biosimilar medicines. The US awaits a similar legal and regulatory framework. Currently, the FDA can only approve a restricted number of simpler ‘follow-on protein products’. Approval of more-complex biosimilars will necessitate a formal legal and regulatory pathway in the US. Visiongain believes that the US Congress will approve a biosimilar bill within a few years. In this report, we predict the emergence of biosimilar products in the US, in addition to developments in other major markets during the years ahead.