My­lan wins ten­ta­tive US ap­proval for gener­ic ver­sion of Lil­ly's Al­im­ta — it could be years be­fore it can be sold

Lil­ly may have fend­ed off com­pe­ti­tion from a pla­toon of gener­ic drug mak­ers and their patent chal­lenges on its chemother­a­py Al­im­ta, but that has not stopped My­lan from se­cur­ing ten­ta­tive US ap­proval for a copy­cat ver­sion.

Al­im­ta was first ap­proved by the FDA in 2004, and the drug’s la­bel has since seen sev­er­al ex­pan­sions. It’s cleared for use in sev­er­al com­bi­na­tions — in­clud­ing with Mer­ck’s star check­point in­hibitor Keytru­da — in cer­tain pa­tients with NSCLC, as well as some pa­tients with ma­lig­nant pleur­al mesothe­lioma. The treat­ment has al­ready gone off-patent in parts of Eu­rope, and its US patents are set to ex­pire in 2022.

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