FDA approves first two interchangeable biosimilars to Regeneron’s blockbuster Eylea

Eylea will even­tu­al­ly have com­pe­ti­tion in the US, as the FDA ap­proved two in­ter­change­able biosim­i­lars.

Mon­day’s ap­provals for Bio­con Bi­o­log­ics’ Yesafili and Sam­sung Bioepis and Bio­gen’s Op­u­viz are based on the com­pa­nies’ abil­i­ty to show that their afliber­cept com­peti­tors have no clin­i­cal­ly mean­ing­ful dif­fer­ences from brand-name Eylea. Yesafili won ap­proval in the UK last No­vem­ber and in Eu­rope last Sep­tem­ber.

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