‘Negotiating the Emerging Biosimilars Landscape’ is a new report published by Business Insights that examines the structure of the biopharmaceutical industry and the strategic approaches taken to alleviate the threat posed by the biosimilar market. The key factors affecting market access within the biosimilars market are assessed and the latest issues surrounding bioequivalence are examined. This report also provides a comprehensive review of the current legislative and regulatory positions of key geographic regions in addition to evaluating their anticipated future legislative changes and outcomes.

Use this report to evaluate the legislative timelines and regulatory pathways to biosimilar approval and understand how to effectively adapt to the threats and opportunities that arise from biosimilar market entry...

• European Union guidelines have been prepared which authorise the use of specific therapeutic biopharmaceutical medicines as biosimilars. However, despite the range of current European guidelines produced by the EMEA, many European governments have issued laws prohibiting the automatic substitution of original products.

• No approval pathway for biosimilars (FOB) exists in the USA, and one is unlikely to exist before 2010. A complex range of Acts and Bills have failed to resolve a number of outstanding legal and regulatory issues.

• India’s biopharmaceutical industry is projected to grow to almost $5 billion by the end of 2010, representing annual growth in excess of 30%. However, despite WTO membership and recent advances in compliance with international regulatory/intellectual property laws, there remains no formal regulatory framework for biosimilars in India or China.

• Health Canada has not yet publicly announced a legal or regulatory framework for biosimilar approval, and no legal framework for biosimilars currently exists in Japan. New regulatory frameworks and biosimilar guidelines are currently under development in both countries.

• Identify and respond to the challenges and threats posed by the emergence of the biosimilars industry with this report’s examination of key trends and strategic approaches used by the biopharmaceutical industry to protect market share and intellectual property.

• Examine details of expired patents or impending patent expiries for first-gen biopharmaceuticals derived from recombinant DNA such as interferons, human insulin and insulin analogs, monoclonal antibodies (Mab) growth hormone and epoietins.

• Evaluate the legislative and regulatory requirements for biosimilars across key geographic regions including Europe, the US, Japan, Australia, Canada as well as the strategically important emerging markets of China and India.

• Assess the factors affecting biosimilar market access with this report’s analysis of the drivers and restraints to biosimilar approval, use and uptake, in addition to an investigation of the problems associated with determining bioequivalence.