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For biosimilar developers, the equivalent analysis focuses on the 351(k) landscape: reference product exclusivity expiration dates (which establish the earliest possible FDA approval date), the biosimilar patent dance posture (whether to engage or opt out), and the competitive field of other biosimilar developers targeting the same reference product
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Most licensed clinics are operating on waitlists, and pricing is only now beginning to stabilise
(1) Ipamorelin is a synthetic pentapeptide, falling under the growth hormone secretagogue receptor (GHSR) agonist category
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