The 505(b)(2) submission journey involves four crucial steps: candidate identification, candidate assessment, product planning, and the pre-IND meeting.
Candidate Identification
The first step involves selecting drug products compatible with the 505(b)(2) pathway, a crucial action that mitigates the risk of failure. It typically involves a few nonclinical studies.
During Phase 1, it’s essential to understand that the new product’s pharmacokinetic (PK) profile need not mirror the innovator product exactly but should be as favorable, ensuring low development risk and distinct market positioning.
Candidate Assessment
This phase is critical for minimizing costly mistakes and validating the product concept’s value to investors.
Candidates should undergo a rigorous evaluation process that examines their scientific, medical, regulatory, and commercial viability.
This thorough assessment ensures that the candidate has a solid foundation and the potential for successful market entry and sustainability.
Product Planning
At this stage, developers should strategically incorporate existing data to optimize their development plans.
Evaluating potential market exclusivity opportunities is crucial, with options ranging from orphan drug exclusivity to new chemical entity (NCE) exclusivity and others.
Even within the 505(b)(2) pathway, there’s a possibility to secure NCE exclusivity, typically associated with 505(b)(1) drugs.
505(b)(2) Pre-IND Meeting
Initiating the pre-IND meeting with the FDA is a pivotal step in the 505(b)(2) pathway, distinguished from the 505(b)(1) process in several ways, including the order of steps and the extent of required studies.
This meeting aims to secure FDA input and agreement on the planned studies and strategies, streamlining the approval process and enhancing investor attractiveness. Using public or previous FDA data can also reduce the need for additional studies, accelerating the timeline and reducing costs.
Let’s dig into the details of the pre-IND meeting in a bit more clarifying detail:
Goals of the pre-IND meeting
The 505(b)(2) process begins with the pre-IND meeting, unlike the 505(b)(1), which starts with formulation development.
It then proceeds to formulation development and any necessary additional studies. The process concludes with the IND filing.
Chronology of actions and steps
The 505(b)(2) process begins with the pre-IND meeting, unlike the 505(b)(1), which starts with formulation development.
It then proceeds to formulation development and any necessary additional studies. The process concludes with the IND filing.
Required studies
Utilization of public data or previous FDA findings is a hallmark of the 505(b)(2) pathway. This allows for bridging studies, reducing the need for extensive clinical or nonclinical studies, a requirement in the 505(b)(1) pathway.
Read also:
- ANDA Suitability Petition Vs 505(b)(2)
- 505 b (1), 505 b(2), 505 b (j) and Para-IV Certification
- Whether to Submit an ANDA or 505(b)(2) Application
Resource Person: Diwakar Shukla