Improved Generic Drugs via the 505(b)(2) Regulatory Pathway: FDA Approval Made Easy

Duration: 90 Minutes
A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug. This unique regulatory pathway, available only for marketing approval in the US, offers an attractive pathway to cheaper and faster new drug development, particularly to a manufacturer with experience in developing generic products.
505(b)(2) Regulatory Pathway
Instructor: Mukesh Kumar
Product ID: 500107
It involves making significant changes to an existing FDA approved product, called reference product, to create a new product with its own indication, formulation, population, and/ or other differences that need to be supported with clinical studies. A major advantage of this pathway is that it allows a sponsor to rely, at least in part, on the FDA’s findings of safety and/or effectiveness for a previously approved drug, thereby reducing the number of clinical trials required for approval. The biggest incentive to develop 505(b)(2) products is 3 years of market exclusivity available to the approved product.

Despite being around for more than 25 years, same as generic drugs, the 505(b)(2) products have only recently become more popular. The main reason is that due to several similarities with generic products, 505(b)(2) products offer some unique challenges. Just like NDAs for new drugs, 505(b)(2) products are subject to full user fee under the Prescription Drug User Fee Act (PDUFA), could require several clinical and non-clinical studies and could take a significant allocation of resources, albeit less than that for a brand new product but much higher than that for a generic drug. Like all drug development strategies, 505(b)(2) pathway requires careful consideration and planning taking into account all the potential issues to be addressed before embarking on development. These issues include intellectual property concerns, supporting information available either from reference products or literature, the logistics of conducting clinical trials with generic-like products, market competition for approved products and business considerations for international product launch. Every year FDA approves about twice the number of 505(b)(2) applications compared to traditional 505(b)(1) applications.

It is projected that due to increased challenges in creating new products, 505(b)(2) products might comprise more than 70% of all FDA approvals over the next 10 years. This pathway is particularly attractive to manufacturers transitioning from generic drugs to innovator products. Due to the similarities with traditional drug development, they offer a low risk market entry point by training the work force in the traditional development processes. However, as would be evident, there are unique challenges to developing such products – scientific, regulatory, logistical and financial – all of which could convert a potentially attractive project into a constant headache.

Why Should you Attend:
This seminar will discuss the practical strategies for drug development via 505(b)(2) regulatory pathway. Key strategic considerations will be discussed using real-life case studies. Also discussed will be role of interactions with the FDA, global clinical trials, market access, reimbursement issues and projected trends for the near future. Lastly, the 505(b)(2) pathway will be compared to that for biosimilars.

Objectives of the Presentation:
  • The 505(B)(2) regulation and guidance from the FDA
  • Strategic considerations before embarking on a 505(b)(2) development project
  • Intellectual property issues with such products
  • Key development steps for such products
  • FDA’s review process and ongoing consultation
  • Challenges to developing 505(b)(2) product and possible solutions
  • Examples of successful strategies for developing such products
  • Searching for a 505(b)(2) project, future trends
  • 505(b)(2) and biosimilars
Learning Objectives:
At the end of the seminar, the attendees will be familiar with the following:
  • FDA guidance on 505(b)(2) products
  • Gap analysis and IND strategy for new formulations of previously FDA-approved drugs
  • Meeting with FDA to discuss 505(b)(2) submissions
  • Trends in FDA review of INDs and NDAs for 505(b)(2) products
  • Do’s and Don’ts for development plans for 505(b)(2) products
Who can Benefit:
  • Regulatory Affairs Professionals
  • Senior Management Executives (CEO, COO, CFO, etc)
  • Drug Discovery and Development Professionals (R&D and CMC)
  • Intellectual Property Experts
  • Project Managers and Clinical Trial Specialists
  • Regulatory Compliance Associates and Managers
  • People Investing in FDA-Regulated Product Development Projects
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Instructor Profile:
Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex Clinical Research, a full service CRO based in Germantown, MD. His key expertise is in developing Global Regulatory Business Strategies for biomedical product development and his passion is to bring traditional therapies for India, China and the Latin-America to the Western markets. In addition to regulatory expertise, Mukesh is an experienced auditor and a trainer in regulatory and business processes.

Mukesh started his professional career as a research scientist at the NIH, Baylor College of Medicine, Houston, and several premier institutions in India. With more than 11 years of experience in virology, gene therapy, and molecular biology, Mukesh has expertise in biological and combination products. He has been a global Regulatory Affairs Specialist (US, EU, and India) for the last 5 years. He has filed several new-INDs for drugs, biologics and combinations products, NDAs, 510K, PMAs, etc. He has made several hundred FDA submissions, and arranged a number of meetings and responses to FDA comments. In addition, he has had made regulatory submission in the EU and India. Mukesh has reviewed/compiled more than 100 clinical trial protocols and has supervised more than 60 multi-national clinical trials (both under IND and non-IND trials), in the US, Canada, Latin America, Africa, and Asia. In addition to drugs and Biologics, he has extensive experience in medical device and diagnostic product regulatory filings and safety monitoring.

Specialties: Technology transfer, global regulatory strategy, global clinical trials, safety reporting, training, and GLP/GCP audits.

Honors and Awards: US patent awarded "Gene Therapy vectors derived from Sendai virus".

Education: Education: Delhi University - Ph.D., Biochemistry - 1993 – 1997
National Dairy Research Institute - MS, Biochemistry - 1990 – 1993
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