Skip to main content
  • login
  • contact
  • language
    • English
    • Français
    • Español
    • Português
    • Deutsch
    • 简体中文
    • 日本語
  • search
X
GEP Logo GEP Logo
  • Company
    • Leadership
    • Customers
    • Partners
    • Sustainability at GEP
    • News
    • Events
    • Culture
    • Mission & Vision
    • Awards & Recognition
  • Solutions
    • Strategy
      • Procurement Consulting  
        • Procurement Transformation
        • Digital Procurement Transformation
        • Opportunity Assessment
        • M & A Services
        • Strategic Cost Management
        • Supply Risk Management
      • Supply Chain Consulting  
        • Environmental, Social and Governance
        • Socially Responsible Sourcing
        • Supply Chain Strategy
        • Supply Chain Diagnostics
        • Inventory Optimization
        • Network Optimization
      Software
      • GEP SMART  
        • Procurement Software
        • Direct Procurement Software
        • Indirect Procurement Software
        • Digital Procurement Transformation
        • Master Data Management
        • AP Automation
        • Spend Management
        • SMART S2P Technology
      • GEP NEXXE  
        • Supply Chain Visibility and Execution
        • Supply Chain Planning
        • Supply Chain Collaboration
        • Supply Chain Control Tower
        • Should-Cost Modeling
        • Inventory and Warehouse Management
      • GEP CLICK  
      • GEP MINERVA  
      Managed Services
      • Procurement Outsourcing  
        • Source-to-Contract
          • Spend Analysis
          • Strategic Sourcing
          • Category Management
          • Supply Market Intelligence
          • Tail-Spend Management
          • Procurement Support Services
        • Procure-to-Pay
          • Cost Recovery & Invoice Auditing
          • Accounts Payable
      • Supply Chain Outsourcing  
        • Planning & Forecasting
        • Inventory Management
        • Logistics Management
        • Supply Chain Data Management
        • Supply Chain Risk Management
  • Industries
    • Automotive
    • Chemicals
    • Consumer Packaged Goods
    • Energy & Utilities
    • Financial Services
    • Government & Nonprofit
    • Industrial Manufacturing
    • Life Sciences
    • Oil & Gas
    • Retail
    • Telecommunications, Media & Technology
    • High-Tech
    • Media & Entertainment
    • Software, Social & Platforms
    • Telecom
    • Travel & Hospitality
  • Knowledge Bank
    • Digital Transformation
    • Software & Technology
    • Strategy & Planning
    • Operations
    • Procurement
    • Sustainability
    • Insights From the Top
    • COVID-19 Resource Center
    • Inflation Strategies
  • Careers
    • Join Us
    • GEP Per Se
    • Campus Connect
  • Partners
   
  • GEP Strategy ›
    • GEP Strategy
    • ‹ Back
      • Procurement Consulting ›
        • Procurement Consulting
        • ‹ Back
          • Procurement Transformation ›
            • Procurement Transformation
            • ‹ Back
              • Procurement Strategy
              • Org. Design & Implementation
              • Capability Building
              • Change Management
              • Governance & Performance
              • Processes & Policies
              • S2P Operations
              • Sourcing & Category Management
              • Technology
          • Digital Procurement Transformation
          • Opportunity Assessment
          • M&A Services ›
            • M&A Services
            • ‹ Back
              • M&A Clean Room
          • Strategic Cost Management ›
            • Strategic Cost Management
            • ‹ Back
              • Zero-Based Budgeting
          • Supply Chain Risk Management
      • Supply Chain Consulting ›
        • Supply Chain Consulting
        • ‹ Back
          • SUSTAINABILITY AND RESILIENCE
          • Environmental, Social and Governance
          • Socially Responsible Sourcing
          • Scope 3
          • PLAN
          • Digital Planning, S&OP, S&OE
          • Collaborative Planning
          • PROCURE
          • Source To Contract
          • Procure To Pay
          • MAKE
          • Inventory Strategy & Management
          • Operations & Manufacturing Excellence
          • DELIVER
          • Network Strategy & Optimization
          • Warehousing & Transportation Management
  • GEP Software ›
    • GEP Software
    • ‹ Back
      • GEP SMART ›
        • GEP SMART
        • ‹ Back
          • Procurement Software
          • Direct Procurement Software ›
            • Direct Procurement Software
            • ‹ Back
              • Bill of Materials Management
              • Data Analytics & Reporting
              • Inventory Management
              • Master Data Management
              • Quality Management
              • Supplier Collaboration Portal
              • Supply Chain Operations
          • Indirect Procurement Software ›
            • Indirect Procurement Software
            • ‹ Back
              • Source-to-Contract
              • Spend Analysis
              • Savings Project Management
              • Category Management
              • Contract Management
              • Savings Tracking
              • Sourcing
              • Supplier Management
              • Procure-to-Pay
              • Guided Buying
              • Procurement Portal
              • Catalog Management
              • Order Processing
              • Invoice Management
          • Digital Procurement Transformation
          • Master Data Management
          • Product Accessibility
          • AP Automation
          • Spend Management
          • SMART S2P Technology
      • GEP NEXXE ›
        • GEP NEXXE
        • ‹ Back
          • Supply Chain Visibility and Execution ›
            • Supply Chain Visibility and Execution
            • ‹ Back
              • Inventory and Warehouse Management
              • Logistics Visibility
              • Control Tower
          • Supply Chain Planning ›
            • Supply Chain Planning
            • ‹ Back
              • Supply Chain Control Tower
              • Should-Cost Modeling
              • Demand Planning
              • Supply Chain Bill of Materials
              • Supply Chain Direct Sourcing
              • Supply Planning
          • Supply Chain Collaboration ›
            • Supply Chain Collaboration
            • ‹ Back
              • Forecast Collaboration
              • Purchase Order Collaboration
              • Quality Collaboration
              • Capacity Collaboration
              • Quality Management Software
          • Supply Chain Control Tower
          • Should-Cost Modeling
          • Inventory and Warehouse Management
      • GEP CLICK
      • GEP MINERVA
      • Innovation ›
        • Innovation
        • ‹ Back
          • Emerging Technologies
          • Native to Cloud
          • Native to Mobile
          • One Unified Platform
          • Security
          • User-Centric Design
  • GEP Managed Services ›
    • GEP Managed Services
    • ‹ Back
      • Procurement Outsourcing ›
        • Procurement Outsourcing
        • ‹ Back
          • Source-to-Contract
          • Spend Analysis
          • Strategic Sourcing ›
            • Strategic Sourcing
            • ‹ Back
              • MRO
              • CAPEX
              • Logistics
              • Packaging
              • IT & Telecom
              • Energy
              • Direct Materials
          • Category Management ›
            • Category Management
            • ‹ Back
              • Contract Management
              • Supplier Performance Management
              • Savings & Compliance Tracking
          • Supply Market Intelligence
          • Tail-Spend Management
          • Procurement Support Services ›
            • Procurement Support Services
            • ‹ Back
              • eSourcing
              • Supplier Performance Management
              • Savings & Compliance Tracking
              • Sourcing Support
          • Procure-to-Pay
          • Cost Recovery & Invoice Auditing
          • Accounts Payable
      • Supply Chain Outsourcing ›
        • Supply Chain Outsourcing
        • ‹ Back
          • Planning & Forecasting
          • Inventory Management
          • Logistics Management
          • Supply Chain Data Management
          • Supply Risk Management
  • Industries ›
    • Industries
    • ‹ Back
      • Automotive
      • Chemicals
      • Consumer Packaged Goods
      • Energy & Utilities
      • Financial Services
      • Government & Nonprofit
      • Industrial Manufacturing
      • Life Sciences
      • Oil & Gas
      • Retail
      • Telecommunications, Media & Technology
      • High-Tech
      • Media & Entertainment
      • Software, Social & Platforms
      • Telecom
      • Travel & Hospitality
  • Knowledge Bank ›
    • Knowledge Bank
    • ‹ Back
      • Digital Transformation
      • Operations
      • Procurement
      • Software & Technology
      • Strategy & Planning
      • Sustainability
      • Podcasts
      • Insights from the Top
      • COVID-19 Resource Center
      • Inflation Strategies
  • Company ›
    • Company
    • ‹ Back
      • Leadership
      • Customers
      • Partners
      • Sustainability at GEP
      • News
      • Events
      • Culture ›
        • Culture
        • ‹ Back
          • GEP Core Values
          • Women@GEP
          • Diversity
          • GEP Cares
      • Mission & Vision
      • Awards & Recognition
      • Contact Us
  • Global Presence ›
    • Global Presence
    • ‹ Back
      • Americas ›
        • Americas
        • ‹ Back
          • English
          • Español
          • Portugués
      • Europe ›
        • Europe
        • ‹ Back
          • English
          • Deutsch
      • Asia-Pacific ›
        • Asia-Pacific
        • ‹ Back
          • English
          • 中文
      • Middle East ›
        • Middle East
        • ‹ Back
          • English
          • العربية
  • Contact Us
  • Careers ›
    • Careers
    • ‹ Back
      • Join Us
      • GEP Per Se
      • Campus Connect
  • Language ›
    • Language
    • ‹ Back
      • English
      • Français
      • Español
      • Deutsch
      • Português
      • 简体中文
      • 日本語
  • Rapid Response from GEP
  • BLOGS
  • Strategy
  • Technology
  • MIND
Contact Us
  •  
  •  
  •  
  •  
  •  
  •  
  •  

Breadcrumb

  1. HOME
  2. BLOG
  3. MIND
  4. HOW 505 B2 IS BECOMING A POPULAR DRUG APPROVAL PATHWAY
Blog Image

How 505 (b)(2) Is Becoming a Popular Drug Approval Pathway

May 07, 2018 | Pharma and Life Sciences Blogs

The pharmaceutical industry is increasingly opting for the 505 (b)(2) regulation as the preferred channel for obtaining Food and Drug Administration (FDA) approval for their drugs. It is a regulatory pathway which pharma companies may adopt to realize cost and time savings. Typically, pharma companies follow the New Drug Application (NDA) pathway for regulatory approval while generic companies follow the Abbreviated NDA (ANDA) pathway. The process of getting an NDA approved from FDA is a lengthy process involving pre-clinical studies, clinical trials on human population and post-approval activities. The average time for a drug to gain approval in the U.S. (post research) is about 12 years. However, submitting a successful ANDA is much simpler without the process complexities involved in an NDA submission.

The 505 (b)(2) regulation acts as a hybrid pathway between the NDA and ANDA. It is suited to drugs which are neither new molecular entities nor generics. For these kinds of drugs, manufacturers can showcase data and results from studies that were previously conducted by another manufacturer. This will help the drug manufacturer steer through all the complex processes involved to get FDA approval. The average time taken for drugs to gain approval via this pathway is about two to three years.

Adoption of 505 (b)(2) by the Industry

Pharma companies and generic manufacturers are both looking to exploit the merits that 505 (b)(2) offers. The number of drug approvals via this path has increased by a staggering 45 percent in 2017 as compared to 2016. There was also a decrease in the review time for drug approval. The review time decreased by 20 percent in 2017 as compared to the average time taken for drug review in 2016. Companies adopting 505 (b)(2) as a channel have to typically conduct a pharmacokinetic study to prove that the change in dosage form and route of administration is safe.

ContraVir Pharmaceuticals has obtained an approval through the 505 (b)(2) channel for their drug used in the treatment of Chronic Hepatitis B. BioStem Technologies has also announced their future plans to develop four drugs using the 505 (b)(2) regulatory pathway. On the back of the potential cost savings which can be realized through this regulation network, top CROs like Syneos Health are providing consulting services to their clients on the regulatory aspect of filing an NDA through 505 (b)(2).

Benefits

The drug approval gained through 505 (b)(2) regulatory pathway attains a market exclusivity of around three to seven years. This is higher than the market exclusivity for the first manufacturer of a generic drug which stands at about three to six months. The sizable time period of market exclusivity offers drug manufacturers an opportunity to strengthen their pipeline and obtain faster turnaround for their drugs. The shorter timelines and reduced complexities lead to significant capital reduction for the drug manufacturer. Compared to generic drugs, the risk of lawsuits for companies following the 505 (b)(2) pathway is lower.

Risks

These are the risks a biopharmaceutical company could face while obtaining the regulatory approval for its drug via 505 (b)(2):

  • Stability and shelf life of the drug may be severely affected on the back of the change in dosage form and route of administration.
  • The price of the innovator drug is comparative to that of the drug passed via 505 (b)(2). The drug manufacturers will find it difficult to justify its price.

Conclusion

Regulation 505 (b)(2) is a hybrid channel for biopharma companies to attain cost savings by making use of previously conducted studies to prove the safety and efficacy of their researched drug. Companies facing pressure due to weak pipelines and patent expirations can use this pathway to achieve faster timelines for their products. Since the drugs approved via this network require less time and financial investment, they can compete with the lower prices of the generic drugs even after market exclusivity is lost.

Sources:

  • http://www.pharmacytimes.com/contributor/ryan-chandanais-ms-cpht/2017/11/505-b2-regulatory-pathway-for-new-drug-approvals-
  • https://camargopharma.com/2018/01/2017-505b2-nda-approvals-increase-dramatically-and-review-times-decrease/
 

Add Comment +

FEATURED POST

...
Supply Chain Strategy Blogs

How to Effectively Monitor Scope 3 Emissions From Your Supply Chain

...
Supply Chain Software Blogs

From Cost to Resiliency: How Supply Chain Priorities Have Changed

    BLOG CATEGORIES

  • Marketing Blogs
  • Professional Services Blogs
  • Pharma and Life Sciences Blogs
  • IT & Telecom Blogs
  • Logistics Blogs
  • Chemicals Blogs
  • Energy & Utilities Blogs
  • Market Intelligence Blogs
  • Oil and Gas Blogs
  • MRO Blogs
  • Supply Chain Blogs
  • Facilities Management Blogs
  • Human Resource Blogs
  • Procurement Process and Excellence Blogs
  • Agro Blogs
  • Direct Materials Blogs
  • CAPEX Blogs
  • Packaging Blogs
  • Automotives Blogs
  • Healthcare Blogs
  • Corporate Travel Blogs
  • Metals & Minerals Blogs
  • Technology Blogs
  • Awards and Events Blogs
  • Category Management Blogs

TAGS

sustainability
Procurement Software
supply chain strategy
Inflation
Russia-Ukraine War

By checking the box below, you consent to GEP using your personal information to send you thought leadership content – such as white papers, research reports, case studies – and other communications. GEP representatives may contact you to provide additional information or answer questions.

If at any point in time you decide to withdraw your consent, you may unsubscribe by emailing your request to us at privacy@gep.com.

Please refer to the GEP Privacy Statement to understand how we manage and protect your personal information.

Terms of Use | Privacy Statement

Contact Us

Ask Us

Send us your question(s)

RFP

Request for a business proposal

Feedback

Share your thoughts, comments and suggestions

Demo

Schedule a live demo of our software

Discover
STRATEGY
Strategy
  •   Procurement Consulting
  •   Digital Procurement Transformation
  •   Strategic Cost Management
  •   Opportunity Assessment
  •   Supply Chain Risk Management
  •   Supply Chain Consulting
  •   Supply Chain Strategy
  •   Supply Chain Diagnostics
  •   Inventory Optimization
  •   Procurement Transformation
  •   Sustainability and ESG Consulting
SOFTWARE
Software
  •   Procurement Software
  •   Supply Chain Software
  •   Source-to-Contract
  •   Procure-to-Pay
  •   Supply Chain Planning
  •   Supply Chain Collaboration
  •   Supply Chain Visibility & Execution
  •   Supply Chain Control Tower
  •   Should-Cost Modeling
  •   Inventory & Warehouse Management Software
  •   Source-To-Pay Software
MANAGED SERVICES
Managed Services
  •   Procurement Outsourcing
  •   Strategic Sourcing
  •   Tail-Spend Management
  •   Category Management
  •   Procurement Support Services
  •   Supply Chain Outsourcing
  •   Supply Chain Planning & Forecasting
  •   Inventory Management
  •   Logistics Management
COMPANY
Company
  •   About Us
  •   Leadership
  •   Customers
  •   Sustainability at GEP
  •   Careers
  •   News
  •   Awards
  •   Partners
  •   Contact Us

Fresh Insights, Now on Your Phone

  • Dowmload On The App Store Button
Stay Connected
  •  
  •  
  •  
  •  

Latest Tweets

  • The #SupplyChain and #procurement #software market is in flux amid #MnA. If your software provider gets acquired, w… https://t.co/orQlKUZB4X

  • #SupplyChain #disruptions are a reality in today's unpredictable world. Learn how @gepsoftware has helped #SGS resp… https://t.co/jA2GnbWIBg

  • What steps can companies take to achieve #ESG goals effectively? Well, they can start with #procurement. Learn how… https://t.co/HGEfNyGdeD

  • #ElectricVehicles are a key part of the auto industry's plan to become #NetZero by 2050. But EVs aren't enough on t… https://t.co/YlEoys6vTA

  • Why did Asahi choose #GEP as their #procurement and #SupplyChain partner? Check out this video featuring Carmen Rad… https://t.co/RmstcfJXtm

  • GEPpers know how to have a good time! Check out a glimpse of our Winter Party at the GEP Prague office. We are hir… https://t.co/BqVK6XkpHv

  • #Inflation has dampened expectations for GDP growth and raised the risks of a #recession. What can #procurement lea… https://t.co/Hn1R5bxZXn

  • 4D seismic #technology is opening deep-sea #OilAndGas reserves for exploration, lowering costs and optimizing reser… https://t.co/Omq51vlEq7

  • The #GEP Europe Outlook 2023 Roadshow is coming to a city near you! Join us to learn the seven critical priorities… https://t.co/Hzv68et4Rr

  • GEP wishes a Happy Republic Day to all the Indians around the world.  We are #hiring. Explore our careers section:… https://t.co/RKTsyBfQFc

  • Sustainability Outlook for 2023: Trends, Insights and Actions 25 Jan 2023 https://t.co/58KIepy577

  • #Pharma companies are reshoring production, but shortages of active pharmaceutical ingredients make it a challenge.… https://t.co/a3uQJhn7tx

  • With uncertainty looming over 2023, there’s no end in sight to the challenges for #SupplyChain and #Procurement lea… https://t.co/O9tWELnt2i

  • Tight timelines and #COVID-related uncertainties made post-merger data ecosystem #convergence a tricky task for thi… https://t.co/RY6du0AP1D

  • Discover the keys to operating a strategic #procurement and supply function at an essential #PetroChemicals company… https://t.co/sJZmqhnWvS

  • What action should business leaders be taking on #sustainability in 2023? Join #GEP Founder and COO @JT_Turimella a… https://t.co/aerbJSp3GU

  • The pandemic and a labor shortage have exposed gaps in #pharma supply chains. Digital #SupplyChain transformation c… https://t.co/Bwvey5ObWn

  • GEP wishes everyone a very Happy Lunar New Year. May this Year of the Rabbit herald fresh starts and renewal of pro… https://t.co/Lnf3ZkO2zJ

  • Facing uncertainty and #disruption, #procurement needs agility — something #ERPs can’t provide. Here are 5 things t… https://t.co/ouGnhfW6wM

© Copyright GEP 2022. All rights reserved. Terms of Use | Privacy Statement | Cookie Policy |   | Quality Policy | GEP Logo