FDA publishes product-specific guidances to facilitate generic drug development Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval, thereby helping to streamline generic drug product development by industry and ANDA assessment by FDA. Today's batch of 39 PSGs includes: - 23 new and 16 revised PSGs
- New PSGs for products used as treatments for diseases or conditions, such as:
- Human Immunodeficiency Virus (HIV)
- Chronic Obstructive Pulmonary Disease (COPD)
- Cushing's Disease
- 28 PSGs for products with no approved ANDAs (including 15 PSGs for complex products with no approved ANDAs)
- 22 PSGs for complex products (11 new and 11 revised PSGs), several of which include in vitro bioequivalence (BE) options for assisting generic drug development. Please see below for notable new PSGs.
When finalized, the guidances in today's batch posting will describe the agency's current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the docket before finalizing PSGs. FDA publishes PSGs to facilitate generic drug development by helping potential applicants efficiently allocate product development resources and prepare more complete submissions, especially for products that do not currently have approved generics. Once these generic products are developed, approved, and marketed, generic competition for these drug products could support greater access to high-quality, safe, effective, and potentially lower-cost treatments. FDA aims to ensure that policies, regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high-quality and affordable medicines supports the agency's mission to advance the public health, as outlined in our Drug Competition Action Plan. Notable new guidances for complex products include: - Ipratropium Bromide Nasal Spray (reference listed drug (RLD): ATROVENT) is available in a high strength (0.042 mg/spray) and low strength (0.021 mg/spray) product for two different indications. This is the first PSG for a locally-acting, solution-based, multi-strength nasal spray product that provides recommendations for abbreviated in vitro BE studies for the lower strength if the in vitro BE studies for the high strength are found acceptable, and the device design between the high and low strengths is sufficiently similar.
- Albuterol Sulfate; Ipratropium Bromide Inhalation Spray (RLD: COMBIVENT RESPIMAT) and Olodaterol Hydrochloride Inhalation Spray (RLD: STRIVERDI RESPIMAT) use a novel delivery device platform called a soft mist inhaler (SMI). Similar to the PSG for another SMI product, FDA recommends a weight-of-evidence approach to establish BE that consists of in vitro BE studies and a pharmacokinetic (PK) BE study. Notably, due to the unique device characteristics of the drug product, a comparative clinical endpoint or pharmacodynamic (PD) BE study is not recommended as part of the weight-of-evidence approach.
- Semaglutide Oral Tablet (RLD: RYBELSUS) is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist product, co-formulated with a stomach absorption enhancer, for the treatment of type 2 diabetes. The new draft PSG provides two options to establish BE depending on the generic applicant's proposed formulation, accounting for possible challenges in matching the formulation of the RLD. Alternative study designs and approaches for a waiver of in vivo BE for lower strength(s) may be acceptable with proper justification.
Newly Updated – Upcoming Complex PSGs Today, FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the Agency's plans for issuing new or revised PSGs in the coming year for complex products as defined in the GDUFA II Commitment Letter. This page is updated each time FDA publishes a new batch of PSGs. New Resource – PSGs "Snapshot" Infographic FDA is excited to announce the availability of a new PSG Snapshot that provides highlights of the FDA's PSG program. The PSGs Snapshot Infographic explains: - What a PSG is and why PSGs are important
- The PSG development timeline for newly approved drugs
- When and where PSGs are published
- How a PSG is developed, and by whom
For more information, to view the guidances, or to submit comments on the PSGs, visit the Federal Register Notice: Product-Specific Guidances. |
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