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This formula also includes liposomal delivery using a phospholipid complex derived from non-GMO sunflower lecithin
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
Institute BCN Item #213
Archived from the original on 28 June 2015
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