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The ANDA pathway devotes specific attention to immunogenicity and recommends the use of orthogonal methods of assessment to demonstrate that a proposed generic drug is immunologically equivalent to its RLD and therefore suitable for submission via the ANDA pathway
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Its mechanism of action involves enhancing insulin secretion in response to elevated blood glucose, suppressing glucagon release, slowing gastric emptying, and reducing appetite
Pre-filled Single-Use Pen Administer one subcutaneous injection at a fixed time each week
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