上海cmc培訓(xùn)developmentandandafilingprocessforagenericextendedreleasedosageform-文庫吧資料
2024-10-25 08:31本頁面
【正文】 of the US Prescription Drug Sales in 2021 $ US Generic Prescription Drug Sales in 2021 ~ $ Current Trend of Generics Opportunities and Challenges ? Opportunity for generic industry in 5 years $87 billion from 2021 to 2021 due to the expiry of patents for blockbuster drugs (source: Goldman Sachs) – 2021 E $650 million – 2021 E $23,451 million – 2021 E $20,157 million – 2021 E $29,647 million – 2021 E $13,170 million Current Trend of Generics Opportunities and Challenges Challenges in Global Pharmaceutical Industry ? Major Consolidations – Mergers between PMA panies recently ? Pfizer with Wyeth ? Merck with ScheringPlough ? Roche with Geech – Mergers between Generic panies ? Watson with Andrx ? Teva with Barr Challenges in Global Generic Pharmaceutical Industry ? Pricing pressure ? Product life cycle management from brand panies – High barrier entry ? Authorized generics – Minimize the benefits for FTF PIV ANDA filings ? Citizens petition – Delay generic market entrance ? Enforcement of regulations Current Strategies of Generic industry ? Generics Continue to Prosper – The use of generic products, including branded generics, increased by % in 2021. – Generics now represent 75% of prescriptions dispensed in the United States, up from 57% in 2021, and account for $74 billion in sales in 2021. – The utilization of branded prescriptions declined by %, and the release of 32 new products in 2021 resulted in only a limited increase in drug spending. – Big pharm started to join the generic petition – Established Products (for example, Pfizer, Abbott, Jamp。J). Current Strategies of Generic industry Current Strategies of Generic industry ? Competition Comparison of an IR Product vs a ER Product in USA Market: – Approvals for an IR Product: 6 – 20 ANDAs ? Metformin Tablets: 15 ANDAs ? Glipizide Tablets: 12 ANDAs – Approvals for a CR Product: 1 – 5 ANDAs ? Nifedipine CR Tablets (AB1): 2 ANDAs ? Diltiazem CR Capsules (AB3): 2 ANDAs Current Strategies of Generic industry ER Products Approved by FDA Company ER Products Country Watson 23 USA Mylan 20 USA Teva 14 USA Impax 12 USA Sandoz 10 USA Zydus 4 India Sun Pharma 3 India Ranbaxy 2 India Dr. Reddy 2 India Cipla 0 India Regulatory Requirements for Filling ANDA by FDA ? Basics for ANDA Approval: – Pharmaceutically Equivalent with Brand Product ? Identical Active Ingredient and Strength(s) ? Identical Dosage Form ? Identical Administration Route ? Stability – Bioequivalent with Brand Product (BE) ? % % of confidence intervals for Cmax and AUC for fasting and nonfasting conditions – Clinically Equivalent. Regulatory Requirements for Filling ANDA by FDA ? Three Major Sections in ANDA Filing – CMC Section – Chemistry, Manufacture and Control Section ? From ANDA owner – a pharmaceutical pany – BE Section – BioEquivalence Study Report. ? From a CRO (Contract Research Organization) pany – Labeling and Insert ? From ANDA owner – a pharmaceutical pany Regulatory Requirements for Filling ANDA by FDA ? Question Based Review (QbR) – QbR is a general framework for the science and riskbased assessment of product quality – QbR contains the important scientific and regulatory review questions ? Evaluate whether a product is of high quality. ? Determine the level of risk associated with the manufacture and design of this product – QbR integrates scientific information to connect CMC information supplied by the sponsor to the product quality expected by the consumer Regulatory Requirements for Filling ANDA by FDA ? Question Based Review (QbR) – Product Development ? Evaluate quality by design. ? Regulatory testing confirms performance of a well designed product. – Process Development ? Provide evidence of sufficient process understanding to successfully scale up production to mercial scale. – Industry ? The Quality Overall Summary (QOS) should address the reviewers’ questions and guide them to appropriate locations in the ap
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