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生物製剤のリコールに関する規制情報:他の薬剤クラスよりも多くのリコールに見舞われた免疫グロブリン・ワクチン

Regulatory Intelligence on Biologics Recalls - Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes

発行 GBI Research 商品コード 234115
出版日 ページ情報 英文 72 Pages
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生物製剤のリコールに関する規制情報:他の薬剤クラスよりも多くのリコールに見舞われた免疫グロブリン・ワクチン Regulatory Intelligence on Biologics Recalls - Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes
出版日: 2012年03月14日 ページ情報: 英文 72 Pages
概要

当レポートでは、米国における生物製剤のリコールに関する規制体制の概況と実績について分析し、全般的状況や規制体制(権限/責任の所在・規制手続きなど)、具体的事例、これまで(2004〜2010年)のリコール実績といった情報を盛り込んで、概略以下の構成でお届けします。

第1章 目次

第2章 イントロダクション

  • 医薬品・生物製剤に対する検査と警告文書
  • 公共医療サービス法案(Public Health Service Act)と生物製剤
  • 医薬品のリコールの過程
  • CDER(医薬品評価研究センター)に報告された医薬品リコール件数
  • CBER(生物製剤評価研究センター)に報告された医薬品リコール件数
  • 当レポートの構成

第3章 概要

  • 生物製剤の概要
  • 生物製剤の製造工程の概況
  • 生物製剤のリコール
  • リコールの理由
  • 医薬品・生物製剤のリスク管理
    • FDAの提言とCMSの利用費還付方針の転換に伴う、ESA(赤血球造血刺激剤)関連のラベリングの改訂
    • Tysabriのラベリングの更新:進行性多巣性白質脳症(PML)のリスク増大に対する警告
  • リコールに関連する規制上の責任と手続き
    • メーカー側のリコール開始の理由
    • FDAの責任と手続きの概要
    • 関連機関の責任
  • ケーススタディ1:Octapharmaによる製造上の問題解決後の、Octagam 5%の市場回帰
  • ケーススタディ2:FDAの失敗を受けたHeparinの危機
  • ケーススタディ3:Sanofi Pasteur社製充填済み注射器向けの2009 H1N1(インフルエンザ)ウイルスの有効期間短縮

第4章 市場動向の分析

  • 生物製剤のリコールの分析(2004〜2010年)
    • リコールの理由
    • 治療領域別のリコール件数
    • 薬剤クラス別のリコール件数
    • 投与形態別のリコール件数
    • 企業別のリコール件数
  • 生物製剤のリコールの分析(2007〜2010年)
    • リコールの理由
    • 治療領域別のリコール件数
    • 薬剤クラス別のリコール件数
    • 投与形態別のリコール件数
    • 企業別のリコール件数
  • 生物製剤のリコールの分析(2007年)
    • リコールの理由
    • 治療領域別のリコール件数
    • 薬剤クラス別のリコール件数
    • 投与形態別のリコール件数
    • 企業別のリコール件数
  • 生物製剤のリコールの分析(2008年)
    • リコールの理由
    • 治療領域別のリコール件数
    • 薬剤クラス別のリコール件数
    • 投与形態別のリコール件数
    • 企業別のリコール件数
  • 生物製剤のリコールの分析(2009年)
    • リコールの理由
    • 治療領域別のリコール件数
    • 薬剤クラス別のリコール件数
    • 投与形態別のリコール件数
    • 企業別のリコール件数
  • 生物製剤のリコールの分析(2010年)
    • リコールの理由
    • 治療領域別のリコール件数
    • 薬剤クラス別のリコール件数
    • 投与形態別のリコール件数
    • 企業別のリコール件数

第5章 付録

図表一覧

目次
Product Code: GBIHC186MR

Summary

GBI Research found that biologics recalls have significantly increased from 2004-2010 due to a number of underlying causes, which are explained in detail in the report. Of biologics recalls made between these years, recalls for vaccines and immunoglobulins were higher than other drug classes. The reasons for recalls varied from serious adverse events, labeling errors and quality defects, to manufacturing defects. Of the biologics recalled since 2004, the highest number of recalls occurred in 2010, followed by 2008. In 2010, the infectious diseases and immunodeficiency disorders therapy areas had the most biologics recalls.

Scope

  • Data and numerical figures on the number of biologics recalls issued according to the year of recall and recalling firm, from 2007-2010.
  • Analysis of leading therapeutic areas and dosage forms for major biologics recalls.
  • Analysis of reasons for recall, along with in-depth analysis of underlying reasons and patterns from 2007-2010.
  • Case studies of companies that have recalled biologic products and re-released products with manufacturing changes or labeling changes.

Reasons to buy

  • Understand the pattern of biologics recalls, along with their underlying causes, in order to enable you to undertake strategies to protect products from encountering safety issues.
  • Analyze the key reasons for recalls, along with the therapy areas and class of recalled biologics most vulnerable, so as to strengthen the areas which may lead to quality defects in your company's products.
  • Reinforce quality and manufacturing strategies in order to be complaint with the current regulatory norms.
  • Develop strategic initiatives through understanding of the key focus areas of biologics recalls.

Executive Summary

GBI Research's report, “Regulatory Intelligence on Biologics Recalls - Immunoglobulins and Vaccines are Involved in More Recalls than Other Drug Classes”, provides in-depth analysis of biologics recalls issued or reported with the US Food and Drug Administration (FDA) and its constituent agencies. The report analyzes biologics recalls on the basis of the reason for recall, therapy area, drug class, dosage forms and the recalling company, on a year-to-year basis from 2007-2010. The report is built on data and information sourced from the FDA database of biologics recalls and in-house analysis by GBI Research's team of industry experts.

Biologics are drugs in which the active substance is produced by or extracted from a biological source. They represent an important part of the therapeutic field. Although a new drug or biologic is approved after elaborate scrutiny of its efficacy and safety, complete understanding of the new drug or biologic is only partial at the time of approval, particularly with reference to the safety profile. This is due to a variety of causes, including limited sample size and the design of randomized controlled trials. This is applicable in the case of small molecules, but biological products and biologics have definite risks. Biologics are derived from living sources such as humans, animals, cells and microorganisms, unlike small molecules, which are synthesized chemically. This makes production and purification processes for biologics more complex. Small differences and changes in the production process could have an impact on the safety profile of biologics. For example, patients treated with recombinant human epoetin can have an incidence of pure red cell aplasia, a rare complication induced by antibodies. This is elevated in patients who take one particular formulation of recombinant human epoetin, in which human serum albumin is replaced with polysorbate 80 and glycine. The exact mechanism underlying the increased risk of pure red cell aplasia after the change in formulation has not been completely ascertained. In addition to this, the risk of contamination with pathogens by the donor is another problem related to the production process for products extracted from human blood or plasma. In October 2005, Biomedical Tissue Services (BTS) recalled human tissue after the company was made aware of the possibility that tissue had been procured from donors without proper medical or social histories. The information also prompted other companies, such as Regeneration Technologies, Inc. and Tutogen Medical, Inc., to recall human tissue products due to information provided by BTS regarding the nature of the tissue obtained from donors.

Immunoglobulins and Vaccines are More Prone to Recalls than Other Drug Classes

There were 14 biologics recalls for vaccines and 13 for immunoglobulins from 2007-2010. This was greater than in other drug classes. The reasons for recalls were serious adverse events, labeling errors, quality defects and manufacturing defects. This indicates that immunoglobulins and vaccines were more prone to recalls than other drug classes.

The Most Biologics Recalls were in 2010

From 2004-2010, there were 63 biologics recalls. There were 17 biologics recalls in 2010, which was the highest number of recalls in a given year in this period. This was followed by 14 recalls in 2008. In 2010, the infectious diseases and immunodeficiency disorders therapy areas recorded the most biologics recalls.

The number of recalls made in 2008 more than doubled from 2007. From 2008-2009, recalls decreased by 71%; however, recalls increased by 325% from 2009-2010.

Quality Defects were the Most Frequent Reason for Biologics Recalls

The majority of errors that occurred from 2004-2010 were due to quality defects, followed by manufacturing errors, labeling errors, serious adverse events and packaging errors. Quality defects encompassed a variety of underlying reasons, such as reduced levels of potency compared to pre-specified levels and the presence of glass particles.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

  • 2.1. Drugs and Biologics Inspections and Warning Letters
  • 2.2. Public Health Service Act and Biologics
  • 2.3. Drug Recall Process
  • 2.4. Drug Recalls Reported by CDER
  • 2.5. Drug Recalls Reported by CBER
  • 2.6. GBI Research Report Guidance

3. Regulatory Intelligence on Biologics Recalls: Overview

  • 3.1. Overview of Biologics
  • 3.2. Overview of Biologics Manufacturing Process
  • 3.3. Biologics Recalls
  • 3.4. Reasons for Recalls
  • 3.5. Risk Management for Drugs and Biologics
    • 3.5.1. Labeling Revisions on ESAs Following FDA Recommendation and CMS Changes to Reimbursement
    • 3.5.2. Updated Labeling of Tysabri to Warn Against Increased Risk of Progressive Multifocal Leukoencephalopathy (PML)
  • 3.6. Regulatory Responsibilities and Procedures Involving Recalls
    • 3.6.1. Reasons for Manufacturers to Initiate Recalls
    • 3.6.2. FDA Responsibilities and Procedures Outline
    • 3.6.3. Responsibilities of the Agencies Involved
  • 3.7. Case Study 1 - Octagam 5% Returned to Market after Resolution of Manufacturing Issues by Octapharma
    • 3.7.1. Octagam 5% Recalled from Markets Due to Increase of Thromboembolic Events (TEEs)
    • 3.7.2. Changes to the Manufacturing Process
    • 3.7.3. Favorable Opinion of Regulatory Authorities and Approval of the Product
  • 3.8. Case Study 2 - Heparin Crisis a Reflection of FDA Failure
    • 3.8.1. Heparin Contamination Forced Several Companies to Recall Products
    • 3.8.2. Source of Contamination was in China
    • 3.8.3. Regulatory Failure Led to Contaminated Heparin Distribution
  • 3.9. Case Study 3 - Shortened Expiration Period for 2009 H1N1 Vaccine in Pre-filled Syringes by Sanofi Pasteur
    • 3.9.1. Five Lots with Lower than Pre-Specified Potency Levels Recalled from the Market
    • 3.9.2. Change of Expiration Date for the Remaining Lots as a Protective Measure

4. Regulatory Intelligence on Biologics Recalls - Trends Analysis

  • 4.1. Analysis of Biologics Recalls 2004-2010
    • 4.1.1. Reasons for Biologics Recalls
    • 4.1.2. Biologics Recalls by Therapy Area
    • 4.1.3. Biologics Recalls by Drug Class
    • 4.1.4. Biologics Recalls by Different Dosage Forms
    • 4.1.5. Biologics Recalls by Companies
  • 4.2. Analysis of Biologics Recalls 2007-2010
    • 4.2.1. Reasons for Biologics Recalls
    • 4.2.2. Biologics Recalls by Therapy Area
    • 4.2.3. Biologics Recalls by Drug Class
    • 4.2.4. Biologics Recalls by Dosage Form
    • 4.2.5. Biologics Recalls by Companies
  • 4.3. Analysis of Biologics Recalls - 2007
    • 4.3.1. Reasons for Biologics Recalls, 2007
    • 4.3.2. Biologics Recalls by Therapy Area, 2007
    • 4.3.3. Biologics Recalls by Drug Class, 2007
    • 4.3.4. Biologics Recalls by Dosage Form, 2007
    • 4.3.5. Biologics Recalls by Companies, 2007
  • 4.4. Analysis of Biologics Recalls - 2008
    • 4.4.1. Reasons for Biologics Recalls, 2008
    • 4.4.2. Biologics Recalls by Therapy Area, 2008
    • 4.4.3. Biologics Recalls by Drug Class, 2008
    • 4.4.4. Biologics Recalls by Dosage Form, 2008
    • 4.4.5. Biologics Recalls by Companies, 2008
  • 4.5. Analysis of Biologics Recalls - 2009
    • 4.5.1. Reasons for Biologics Recalls, 2009
    • 4.5.2. Biologics Recalls by Therapy Area, 2009
    • 4.5.3. Biologics Recalls by Drug Class, 2009
    • 4.5.4. Biologics Recalls by Dosage Form, 2009
    • 4.5.5. Biologics Recalls by Companies, 2009
  • 4.6. Analysis of Biologics Recalls - 2010
    • 4.6.1. Reasons for Biologics Recalls, 2010
    • 4.6.2. Biologics Recalls by Therapy Area, 2010
    • 4.6.3. Biologics Recalls by Drug Class, 2010
    • 4.6.4. Biologics Recalls by Dosage Form, 2010
    • 4.6.5. Biologics Recalls by Companies, 2010

5. Regulatory Intelligence on Drug Recalls - Appendix

  • 5.1. Market Definitions
  • 5.2. Abbreviations
  • 5.3. Research Methodology
    • 5.3.1. Coverage
    • 5.3.2. Regulatory Intelligence on Biologics Recalls - Overview
    • 5.3.3. Regulatory Intelligence on Biologics Recalls - Trend Analysis
  • 5.4. Contact Us
  • 5.5. Disclaimer
  • 5.6. Sources

List of Tables

  • Table 1: Regulatory Intelligence on Biologics Recalls, Total Number of Recalls by All Agencies, 2007-2010
  • Table 2: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CDER, 2007, 2008 and 2010
  • Table 3: Regulatory Intelligence on Biologics Recalls, Number of Drug Product Recalls by CDER by Class, 2007, 2008 and 2010
  • Table 4: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CBER, 2007, 2008 and 2010
  • Table 5: Regulatory Intelligence on Biologics Recalls, Number of Biological Product Recalls by CBER by Class, 2007, 2008 and 2010
  • Table 6: Regulatory Intelligence on Biologics Recalls, Product Recalls by CDER, CBER and Other Agencies, 2007, 2008 and 2010
  • Table 7: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2004
  • Table 8: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2005
  • Table 9: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2006
  • Table 10: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2007
  • Table 11: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2008
  • Table 12: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2009
  • Table 13: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2010
  • Table 14: Regulatory Intelligence on Biologics Recalls, , Biologics Recalls by Reason for Recall, 2004-2010
  • Table 15: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, By Year, 2004-2010
  • Table 16: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2004-2010
  • Table 17: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, By Year, 2004-2010
  • Table 18: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2004-2010
  • Table 19: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, By Year, 2004-2010
  • Table 20: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2004-2010
  • Table 21: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, By Year, 2004-2010
  • Table 22: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2004-2010
  • Table 23: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, By Year, 2004-2010
  • Table 24: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007-2010
  • Table 25: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007-2010
  • Table 26: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007-2010
  • Table 27: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007-2010
  • Table 28: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2007-2010
  • Table 29: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007
  • Table 30: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007
  • Table 31: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007
  • Table 32: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007
  • Table 33: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2007
  • Table 34: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2008
  • Table 35: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2008
  • Table 36: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2008
  • Table 37: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2008
  • Table 38: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2008
  • Table 39: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2009
  • Table 40: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2009
  • Table 41: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2010
  • Table 42: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2010
  • Table 43: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2010
  • Table 44: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2010
  • Table 45: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies, 2010

List of Figures

  • Figure 1: Regulatory Intelligence on Biologics Recalls, Total Number of Recalls by All Agencies, 2007-2010
  • Figure 2: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CDER, 2007, 2008 and 2010
  • Figure 3: Regulatory Intelligence on Biologics Recalls, Number of Drug Product Recalls by CDER by Class, 2007, 2008 and 2010
  • Figure 4: Regulatory Intelligence on Biologics Recalls, Drug Recalls by CBER, 2007, 2008 and 2010
  • Figure 5: Regulatory Intelligence on Biologics Recalls, Number of Biological Product Recalls by CBER by Class, 2007, 2008 and 2010
  • Figure 6: Regulatory Intelligence on Biologics Recalls, Product Recalls by CDER, CBER and Other Agencies, 2007, 2008 and 2010
  • Figure 7: Regulatory Intelligence on Biologics Recalls, Biologics Manufacturing, Biologics Classification, 2009
  • Figure 8: Regulatory Intelligence on Biologics Recalls, Biologics Manufacturing, Biologics Manufacturing Steps, 2009
  • Figure 9: Regulatory Intelligence on Biologics Recalls, Reasons for Manufacturing Initiating Recalls
  • Figure 10: Regulatory Intelligence on Biologics Recalls, FDA Responsibilities
  • Figure 11: Regulatory Intelligence on Biologics Recalls, Total Number of Biologics Recalls, 2004-2010
  • Figure 12: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2004-2010
  • Figure 13: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2004-2010
  • Figure 14: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2004-2010
  • Figure 15: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2004-2010
  • Figure 16: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2004-2010
  • Figure 17: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, By Year, 2004-2010
  • Figure 18: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall, 2007-2010
  • Figure 19: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area, 2007-2010
  • Figure 20: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class, 2007-2010
  • Figure 21: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form, 2007-2010
  • Figure 22: Regulatory Intelligence on Biologics Recalls, Recalls by Companies, 2007-2010
  • Figure 23: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2007
  • Figure 24: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area (%), 2007
  • Figure 25: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class (%), 2007
  • Figure 26: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form (%), 2007
  • Figure 27: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2007
  • Figure 28: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2008
  • Figure 29: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area (%), 2008
  • Figure 30: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class (%), 2008
  • Figure 31: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form (%), 2008
  • Figure 32: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2008
  • Figure 33: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2009
  • Figure 34: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2009
  • Figure 35: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Reason for Recall (%), 2010
  • Figure 36: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Therapy Area (%), 2010
  • Figure 37: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Drug Class (%), 2010
  • Figure 38: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Dosage Form (%), 2010
  • Figure 39: Regulatory Intelligence on Biologics Recalls, Biologics Recalls by Companies (%), 2010
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