Company: GNMSF
Filing Date: 2025-02-12
Form Type: 20-F
Source: 0001558370-25-000846
Chunk: 67

Company: GENMAB A/S
Filing Date: 2025-02-12
Form: 20-F
Item: Item 4I
Chunk 67
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 of Biologic Products in the U.S.
Biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and other federal, state, local and foreign statutes and regulations. Our product candidates must be approved by the FDA before they may be legally marketed in the U.S.
The process required by the FDA before biologic product candidates may be marketed in the U.S. generally involves the following:

●   completion of pre-clinical laboratory tests and animal trials performed in accordance with the FDA’s current Good Laboratory Practices (“cGLPs”) regulation;
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●   submission to the FDA of an IND, which must become effective before clinical trials may begin and must be updated annually or when significant changes are made;
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●   approval by an independent Institutional Review Board (“IRB”), or ethics committee at each clinical site before the trial is begun;
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●   performance of adequate and well-controlled human clinical trials to establish the safety and potency of the proposed biologic product candidate for its intended purpose;
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●   preparation of and submission to the FDA of a BLA, after completion of all pivotal clinical trials;
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●   a determination by the FDA within 60 days of its receipt of a BLA to accept the application for review;
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●   satisfactory completion of an FDA Advisory Committee review, if applicable;
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●   satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the proposed product is produced to assess compliance with cGMP 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 investigations to assess compliance with current cGCPs; and
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●   FDA review and approval of the BLA to permit commercial marketing of the product for particular indications for use in the U.S., which must be updated when significant changes are made.
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Prior to beginning the first clinical trial with a product candidate in the U.S., we or our collaboration partner must submit an IND to the FDA. An IND is a request for authorization from the FDA to administer an IND product to humans. The central focus of an IND submission is on the general investigational plan and the protocol(s) for clinical trials. The IND also includes results of animal and in vitro trials assessing the toxicology, pharmacokinetics, pharmacology, and pharmacodynamic characteristics of the product; chemistry, manufacturing,