Eli Lilly is facing the threat of competition to its big-selling short-acting insulin Humalog after Sanofi claimed full FDA approval for a rival version.
Sanofi’s drug – called Admelog (insulin lispro) – has been approved via the FDA’s 505(b)(2) regulatory route for follow-on biologics, rather than the biosimilar route which is currently not open to insulin products. This is a less expensive and quicker new drug development pathway that can be used for drugs that aren’t new but differ from the original brand in certain ways, such as formulation or delivery system.
Admelog was approved as a biosimilar by the European Commission in July, and granted tentative approval by the FDA in September. Sanofi’s head of diabetes and cardiovascular – Stefan Oelrich – has previously said that given that it is late in the year contracting access and reimbursement with payers could be challenging in 2018, and the company expects the drug to make more of an impact commercially in the following year.
It’s something of a tit-for-tat scenario for the two companies, as Lilly used the same regulatory pathway in 2015 to win approval for Basaglar, its follow-on version of Sanofi’s blockbuster Lantus (insulin glargine) product. Now Sanofi can go after one of Lilly’s big brands – Humalog made $2.1bn in sales for Lilly in the first nine months of the year, a rise of 7% over the same period of 2016.
Admelog is the first FDA-approved follow-on mealtime insulin and has been cleared for use in children older than three and adults with type 1 diabetes, as well as adults with type 2 diabetes. The conversion to full approval from tentative approval suggests that further patent litigation will not be an issue. Lilly’s patents on Humalog expired in 2013 but there had been speculation it may try to block Admelog based on a remaining patent for its KwikPen delivery device which expires next year.
Humalog is just one of Lilly’s big brands facing competition, along with erectile dysfunction therapy Cialis (tadalafil) and antiplatelet drug Effient (prasugrel), and the company recently announced sweeping job cuts in a bid to trim $500m off its costs as it brings a new generation of products to market.
In a statement issued after Admelog’s approval, FDA commissioner Scott Gottlieb said that one of his main targets is “increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease”.
He promised to deliver “additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways”.