Mylan Eylea Biosimilar Gets Green Signal For Trials In India
Mylan’s proposal to progress studies for its aflibercept biosimilar has been endorsed by an expert panel in India, which expects availability of such biosimilars to expand access to anti-VEGF therapies.
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South Korean biotech Alteogen is progressing the development of its Eylea biosimilar both at home and abroad, with the hope of becoming a global first mover with its version in wet AMD, backed by formulation and manufacturing patents.
Intas Pharmaceuticals has claimed that certain adverse events reported with its Lucentis biosimilar were not caused by “qualitative aspects” of the product and that physicians have since “very satisfactorily” used subsequent batches of the vascular endothelial growth factor inhibitor in India.
The WHO’s new "living guideline" against remdesivir’s use in hospitalized patients notwithstanding, some key opinion leaders in India see a role for the antiviral, but underscore that COVID-19 is still in its infancy and all repurposed therapies for the disease still have a long way to go. They also see the US remdesivir studies as more robust.