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

Description :

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. 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.

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.

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.

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

Areas Covered in the Session :

• 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