Mylan, Biocon undercut insulin competitors on price with launch of Lantus copycat

After years of manufacturing woes torpedoed their chances to challenge Sanofi’s blockbuster insulin injection Lantus, Mylan and Biocon recently received the FDA’s go-ahead to launch their knockoff. Now, making up for lost time, the partners are pricing copycat Semglee at a price far below their competitors.
Mylan and Biocon will launch Semglee, a copy of Sanofi’s insulin injection Lantus, for a wholesale acquisition cost of $147.98 per package of five 3-milliliter pens and $98.65 per 10-milliliter vial, making it the lowest-priced basal insulin on the U.S. market, the partners said Monday.
The Semglee pen starting wholesale price is the same as Lantus’ launch price from 2007, Mylan said, and the vial is listed at Lantus’s 2010 pricing.
The FDA approved Semglee in April to hit the U.S. market after years of manufacturing concerns at Biocon’s Malaysian manufacturing facility. The partners are seeking the FDA’s biosimilar approval for Semglee, allowing it to market as interchangeable with Lantus.
The FDA gave its long-awaited green light to Semglee after tagging Biocon’s Malaysian plant in April with a voluntary action indicated, a rating that indicates the facility meets at least the minimum FDA standards.
The finding follows a February inspection that resulted in a Form 483 with three observations, which were not disclosed in a Biocon statement at the time.
The facility had twice been knocked back in the past after the FDA cited a slew of problems in two separate complete response letters.
The latest, which Biocon received in September 2019, related to “pending improvements” tied to the first letter in June 2018, which cited 12 observations at the site’s three operations facilities.
Meanwhile, Semglee is hoping to directly challenge Lantus’ grip on the insulin market, which has loosened in recent years as copycats continue to storm in. The drug brought in $1.42 billion in second quarter sales for Sanofi, which was a roughly 7.5% decline from the same time period last year.

Source : fiercepharma