Company: EVGN
Filing Date: 2025-03-27
Form Type: 20-F
Source: 0001178913-25-001092
Chunk: 90

Company: Evogene Ltd.
Filing Date: 2025-03-27
Form: 20-F
Item: Item 4
Chunk 90
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, storage, distribution, record keeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs and biologics such as those Biomica is developing. Biomica, along with its contract manufacturers, will be required to navigate the various pre-clinical, clinical and commercial approval requirements of the governing regulatory agencies of the countries in which it wishes to conduct studies or seek approval for its product candidates. The process of obtaining regulatory approvals and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.
 
In the United States, the FDA regulates drug and biologic products under the FFDCA, its implementing regulations and other laws, including, in the case of biologics, the Public Health Service Act. Biomica’s product candidates are subject to regulation by the FDA as biologics. Biologics require the submission of a biologics license application, or BLA, and approval by the FDA before being marketed in the United States.
 

The process required by the FDA before Biomica’s biologic product candidates may be marketed in the United States generally involves the following:
 
• completion of preclinical laboratory tests and animal studies performed in accordance with the FDA’s good laboratory practice, regulations;
 
• submission to the FDA of an investigational new drug application, which must become effective before clinical trials in the United States may begin;
 
• approval by an institutional review board, or ethics committee at each clinical site before a trial is commenced;
 
• performance of adequate and well-controlled human clinical trials to establish the safety, purity and potency of the product candidate for each proposed indication, conducted in accordance with the FDA’s good clinical practice, or GCP, regulations;
 
• preparation and submission to the FDA of a BLA after completion of all pivotal trials;
 
• satisfactory completion of an FDA Advisory Committee review, if applicable;
 
• determination by FDA within 60 days of its receipt of a BLA to file the application for review;
 
• satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the product is produced to assess compliance with GMP regulations, and to assure that the facilities, methods and controls are adequate to preserve the biological product’s continued safety, purity and potency, and of selected clinical investigation sites to assess compliance with GCPs; and
 
• FDA review and approval of the BLA prior to any commercial marketing, sale or shipment of the product.
 
The testing and approval process requires substantial