rBIO announced that it has completed all the required analytical characterizations of its insulin biosimilar, R-biolin. This positions the company to file for the 351(k) drug submission process — an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference product.
Read MorerBIO's platform for synthetic insulin achieves success as the team looks to production scale-up and a range of other prescription drugs to target.
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