IHL (ASX) General discussion

Originally posted by piyashrija: ↑

Approval times for 505(b) 2
The real time and cost saving for 505(b)(2) products comes from reduced development programs due to smaller and/or fewer studies rather than abbreviated review times.
505(b)(2) Products Approved in One Review Cycle
Of the applications approved via the 505(b)(2) regulatory pathway from 2009 – 2015, 64.5% were approved with only 1 review cycle. In some of these cases, preventable review delays occurred due to Refuse-To-File determinations, and the need to submit major amendments.

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Compared to 505(b)(1), the 505(b)(2) process differs greatly. Here’s how:

The order of the steps:

The 505(b)(2) process begins with the pre-IND meeting with the FDA, then moves to formulation development (and studies, if necessary) and then to the IND filing.

The goals of the pre-IND meeting: for a 505(b)(2) product PIND strategy is different than for a 505(b)(1). In proposing a 505(b)(2) development strategy in a pre-IND meeting, the objective is to gain FDA input and concurrence with the studies, with the chemistry, manufacturing, and controls (CMC) strategy and with clinical research plans in a way that minimizes the number of new studies required. For many companies, obtaining FDA buy-in and successfully activating an IND are critical steps for securing investments.

The number and type of studies required: Since the 505(b)(2) pathway allows the use of public data or the FDA’s previous findings in lieu of novel trial data, some development programs may conduct bridging studies that preclude the need for nonclinical or clinical studies, or both.

Timing of CMC work: For a 505(b)(2) product, the clinical trial materials for Phase I studies (often demonstrations of clinical bioequivalence) must be representative of the commercial manufacturing process, including packaging. In general, the three stability batches that will be used for shelf-life determinations are also prepared at this time. As a consequence, a good deal of CMC work must be invested prior to initiating even Phase I studies.

Timing of studies: Because 505(b)(2) development plans rely largely on pre-existing data, and clinical studies can often be started simultaneously and developed in parallel, significantly shortening the overall time to market.

Together, these differences represent a formidable multifaceted challenge. When mishandled, the early steps of 505(b)(2) development can end in product-development failure. On the other hand, when managed skillfully, these first steps can result in important victories for the sponsor, including reduced costs, a clear path to approval and immediate interest from investors.

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