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But increased competition is on the horizon. Tentative approval means Lumryz has satisfied all the FDA requirements for efficacy, safety, and quality standards, but it can’t be fully approved until a patent or other exclusivity expires. Competition starts to heat up. Classic treatment options. Two decades of exclusivity.
It is, however, the first that can be substituted across all Lucentis’ five indications and to be fully interchangeable – which means it is considered to have no clinically meaningful difference compared to the reference drug in safety, purity, or potency and can be substituted for it without any prescriber intervention.
The revision process is reviving old conflicts in the pharma industry over fair and affordable access to medicines versus Europe’s status as a competitive home for pharma innovation. EU competitiveness Moll said the legislation revisions should instead be used to make Europe more attractive to pharma companies.
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