Strategic Use of FOI-Based Biopharmaceutical Reviews in Generic Drug Development

In the development of generic pharmaceutical products, aligning formulation design and regulatory strategy with prior approved data significantly improves the chances of first-time-right submissions. One highly effective method to gain such insight is through the use of biopharmaceutical review documents obtained via FOI requests. These documents, available publicly through regulatory agencies such as the USFDA (via Drugs@FDA) and EMA (through EPARs), contain comprehensive reviews conducted during the approval of reference listed drugs (RLDs) or earlier approved ANDAs.

Biopharmaceutical reviews provide critical, regulator-verified information that includes dissolution testing conditions, in vitro–in vivo correlation (IVIVC), bioequivalence (BE) study design and acceptance criteria, BCS classification, food-effect studies, and justification for strength biowaivers. This information forms a scientifically robust foundation upon which generic development teams can base decisions on formulation composition, BE study design, and waiver applicability. For example, when an FOI review confirms that the RLD has high solubility and high permeability, classifying it as BCS Class I, and shows that linear pharmacokinetics have been established, this can be used to justify a biowaiver for lower strengths in a generic product if other criteria—such as Q1/Q2 similarity and proportionality—are also met.

Furthermore, the FOI review documents often describe in detail the dissolution method and media used by the innovator or accepted by the regulator, which can be directly adopted in method development. This avoids guesswork and reduces the likelihood of post-submission queries or deficiencies. Similarly, if the RLD’s BE study was accepted under a fasting condition only, with no significant food effect observed, the generic sponsor may adopt the same BE study conditions, subject to confirmation through literature or bridging data.

Importantly, FOI-based biopharmaceutical information can be used strategically across multiple modules of the Common Technical Document (CTD):

• Module 2.5 / 2.7.1: To justify BE strategy and strength selection.
• Module 3.2.P.2: To support excipient selection, proportionality rationale, and formulation alignment with the RLD.
• Module 5.3.1.2: To document and cross-reference BE study design in line with regulator-accepted parameters.

By adopting this approach, generic developers can reduce development timelines, minimize regulatory risk, avoid redundant studies, and increase the likelihood of regulatory acceptance—particularly when filing under strict regulatory pathways such as the USFDA, EMA, or MHRA. It also enables better cost control and resource allocation, especially in cases where BE studies are resource-intensive.

In conclusion, biopharmaceutical reviews enable developers to de-risk formulation choices & strengthen regulatory justification.

Read also:

• 22 Sections of an ANDA
• Online Biopharmaceutics Classification Database
• Importance of Understanding the Biopharmaceutics Classification System

Resource Person: Moinuddin Syed. Ph.D, PMP®