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Negotiating the Emerging Biosimilars Landscape: Key Developments in the Regulatory Environment
Business Insights, Feb 2009, Pages: 224
As regulatory obstacles to biosimilars development have become increasingly resolved, a growing number of opportunities have been created for generics companies in the biopharmaceutical market, which according to IMS data was valued at $85.9 billion in 2007. Conservative projections estimate that sales of biopharmaceutical products will exceed $135 billion by 2011. With some of the earliest biopharmaceuticals having already lost patent protection, the originators of biopharmaceutical products are facing intense competition from generics developers. In response, originators are resorting to a range of defensive tactics, including the reformulation of existing products to improve efficacy, the implementation of more efficient delivery systems and the pursuit of high-level intellectual property (IP) battles.
‘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.
Key Findings:
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.
Use this report to
- 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.
Explore issues including
Impending patent expiries. The critical challenge facing the biopharmaceutical industry is the expiry or pending expiry of patents for first generation biopharmaceuticals derived from recombinant DNA such as interferons, growth hormone and epoietins.
Defensive strategies. As part of efforts to protect the market share of products with impending patent expiries, originator biopharmaceutical companies have begun to protect intellectual property and engage in strategic alliances, joint ventures and mergers between themselves and major pharma companies.
Geographical disparities in biosimilar legislation. Different geographic regions have varying legislative approaches to the regulation and/or approval of biosimilars. Such discrepancies often lead to misunderstandings and can result in complexity and complication during the approval process.
Discover
- Which biopharmaceutical companies are at risk from product patent expires?
- What is the status of the analytical techniques used for determining bioequivalence?
- What tactics prove most effective for originator biopharmaceutical companies who wish to protect their market position?
- What effect the market entry of second generation biopharmaceuticals by originator companies have on the biosimilars market?
- What are the growth drivers and restraints of the biosimilars market?
- How are global healthcare costs influenced by biosimilar market entry prospects?
- What is the current legislative and regulatory status of biosimilars in Europe and the US?
- How will China and India influence the biopharmaceutical and biosimilars market in the future?
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