Biosimilars: Key developments in the regulatory environment
This report examines the structure of the biopharmaceutical industry and the strategic approaches taken to alleviate the threat posed by the biosimilar market. It 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.
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European Union guidelines have been prepared which authorize 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 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.
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In collaboration with Regulanet network of regulatory affairs consultants throughout Europe and USA, we keep
daily contacts and communication with National Agencies for Medicines
and Medical Devices. Beside regulatory we also maintain understanding of the business, scientific and technical background of products.
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