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  4. > Regulatory Trends in the US Pharma/Biotech Industry : Efficiency of the FDA Review Process Expedites Access to Care

Key Findings

•In terms of the number of new molecular entities (NME) approved by the US Food and Drug Administration (FDA), 2014 marked a record year in the pharma/biotech industry, with the highest number of NMEs approved in the last decade. In terms of highest number of filings, regulatory submissions were at their peak in 2014, tied with 2011 and 2012.
•The number of orphan drugs entering the US market grew by x % in 2014, compared to 2013, demonstrating that companies continue to target this market with its large unmet needs, fewer competitors, and a potentially higher return on investment.
•The efficiency of the US FDA’s review of drug submissions continues to improve as a result of its expedited review designations: fast track, breakthrough, priority review, and accelerated approval.
•The number of approved NMEs in the United States that was granted first-class designation increased significantly in 2014, compared to previous years, demonstrating that pharma and biotech companies are focusing on launching novel mechanism of actions (MOA) and are focusing on targeted therapies to treat medical conditions and specific populations.
•Because of its benefits of convenience and overall safety, oral administration continues to be the dominant mode of administration for drugs approved in the United States.
•The lack of a clear biosimilar regulatory pathway in the US market continues; no biosimilars were approved in the United States in 2014.

Most Approved NMEs Evaluated as an Expedited Review

Key Takeaway: While the percentage of expedited reviews declined between 2013 and 2014, the overall number increased, showing that companies are continuing to innovate and fulfill large unmet needs.

•Fast track is assigned to drugs with the potential to fulfill an unmet need. These drugs are reviewed in an expedited fashion by being part of a rolling review process and increased level of communication between the FDA and the manufacturer.
•Breakthrough is assigned to drugs showing early evidence that there is significant improvement, compared to alternative therapies.
•Priority review is assigned to drugs with the potential to fulfill a significant unmet medical need. In this instance, the drug review process can end as soon as x months, compared to the standard x months.
•Accelerated approval is assigned to drugs with the potential to treat a life threatening condition.
•Compared to x out of 27 ( x %) in 2013, an impressive x out of x ( x %) approved NMEs were assigned at least 1 of 4 expedited regulatory review designations in 2014, compared to the standard review.

Table Of Contents

Regulatory Trends in the US Pharma/Biotech Industry : Efficiency of the FDA Review Process Expedites Access to Care
Executive Summary 3
• Key Findings 4
Analysis of 2014 New Molecular Entities US FDA Filings and Approvals 5
• NME Trends Show Significant Increase in Regulatory Filings and Approvals 6
• Increase in Orphan Drug Approvals 7
• Increase in First-in-class Designation 8
• Most Approved NMEs Evaluated as an Expedited Review 9
• High Number of First Cycle Approval Continues 10
• Oral Therapies Continue Dominating the Pharma/Biotech Industry 11
• NMEs Approved in 2014 12
Frost and Sullivan Predictions for 2015 27
• Frost and Sullivan Predictions for 2015 28
• Legal Disclaimer 29
The Frost and Sullivan Story 30

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