FDA Highlights Off-Patent Opportunities
Latest Update To List Of Products Open To Competition With No Rivals
Opportunities for generic competition have been highlighted by the FDA, in the latest update to its list of products that are not protected by patents or exclusivities but have no approved rivals.
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US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.
Innovent Biologics has broadened its international reach by striking a licensing deal with PT Etana Biotechnologies in Indonesia for its Byvasda bevacizumab biosimilar.