Merck, Samsung Bioepis end development on copy of Sanofi's Lantus
- Merck & Co. and Samsung Bioepis jointly bailed on bringing a diabetes insulin treatment to market that would have mimicked Sanofi's Lantus, both drugmakers confirmed to BioPharma Dive on Friday.
- According to a Korean stock exchange disclosure form, Merck will pay Samsung Bioepis a termination fee of roughly $155 million. The disclosure also stated the Korea-based company had invested a total of about $91 million in the drug, leaving a net profit from the cancellation of roughly $64 million.
- Although Lusduna was technically not a biosimilar, as a copy of a biologic it would have faced similar market pressures. As a follow-on biologic, it adhered to different legal and regulatory frameworks. The cancellation was first reported by Scrip.
Terminating Lusduna (insuling glargine) development was more about the market for insulins than biosimilars. Insulin manufacturing has been plagued by high costs in recent years for most of the industry, which appeared to influence Merck's decision to leave the agreement.
Lusduna was scrapped by the companies after a recent review of the market for the drug, including looking at pricing and cost production expectations, a Merck spokesperson said in an emailed statement. A spokesperson for Samsung Bioepis referenced the statement from its partner when asked for comment.
"As a result of this decision, Merck will begin to reallocate resources including commercial and manufacturing capacity related to insulin glargine to other products," the Merck spokesperson wrote.
At the same time, both companies reaffirmed their commitment to the biosimilar market, though, saying it won't affect other copycat biologics the two are developing together.
"We believe that biosimilars can present significant opportunities for cost savings through competition and improved patient access to therapies," the Merck spokesperson stated.
For Sanofi, the decision takes out another imminent competitor to its fading yet still high-revenue diabetes drug.
Despite competition from Eli Lilly and Boehringer Ingelheim's follow-on biologic Basaglar (insulin glargine), Lantus (insulin glargine) posted sales of 4.6 billion euros (about $5.3 billion) in 2017 and 1.8 billion euros ($2.1 billion) in the first half of 2018.
Still, the competition has taken a toll on Lantus since Basaglar launched in late 2016. In its 2017 annual report, Sanofi said CVS and UnitedHealthcare each dropped coverage of Lantus from their formularies in 2016, despite an increasing level of rebates offered by the French pharma.
- BioPharma Dive Biosimilars are beginning to bite for Sanofi