Will Companies Be Able to Launch ‘Authorized Biosimilars’ In The Future? Eli Lilly Wants To Know
In response to FDA draft guidance reclassifying certain NDA “drugs” as BLA “biologics,” Eli Lilly is asking the FDA to clarify whether regulatory mechanisms exist for biological product sponsors to introduce ‘second versions’ of their innovative biological products.
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Eli Lilly has launched its authorized generic of its own Humalog (insulin lispro) brand in the US, at a 50% discount to the list price of the original.
Eli Lilly has announced plans to introduce a generic version of its Humalog insulin lispro in the US at a 50% discount to the brand’s list price. However, political pressure is continuing to mount over the lack of availability of cheaper alternatives.
As the FDA publishes several key guidance documents on biosimilars and biologics, Commissioner Scott Gottlieb has outlined the latest steps in the agency’s ongoing efforts to support the market. These include measures to address the abuse of REMS, as well as transitioning products such as insulin and human growth hormone into the biologics framework.