China’s Luye Pursues Global Differentiation Strategy
Luye Pharma says it is making sound progress in developing a pipeline of added-value injectables and transdermal patches, while clinical trials for two biosimilars are also moving forward.
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Highlights of year-end application submissions including candidates from AstraZeneca, BioMarin, Lilly, MorphoSys, and Seattle Genetics.
Several firms are making progress on added-value risperidone formulations: Luye Pharma anticipates FDA approval for its extended-release microspheres; Rovi is moving towards a US 505(b)(2) filing for its Doria once-monthly formulation; and Indivior has introduced its Perseris subcutaneous suspension in the US.
Germany’s off-patent industry association, Pro Generika, is finding ample support for its position that by awarding tender contracts to exclusive suppliers, health insurance funds are contributing to drug shortages in the country.