Semglee, the brand name of Mylan and Biocon’s Lantus copy, came to market in Europe in 2018. The partners tried to win US Food and Drug Administration (FDA) approval for the insulin glargine injection via the 505(b)(2) regulatory pathway around the same time, only to be rebuffed by the agency.
The FDA finally approved Semglee, at the third time of asking, in June, clearing Mylan and Biocon to start trying to win market share from a Sanofi drug that generated sales of €1.1 billion ($1.3 billion) in the US last year.
Mylan has set the wholesale acquisition cost (WAC) — the price before discounts or rebates — at $147.98 per pack of five 3ml pens. The WAC per 10ml vial is $98.65.
The rates effectively rewind a decade or more of price increases by Sanofi. Mylan said its list prices are equivalent to those Sanofi set for the pens and vials in 2007 and 2010, respectively.
Mylan and Biocon have high hopes for the launch. Biocon Biologics, the biosimilar unit of the Indian drugmaker, is looking to Semglee to “contribute significantly” to its goal of generating revenues of $1 billion by the end of fiscal 2022, while Mylan sees the product furthering its aspiration to reach one in five insulin-dependent people worldwide.
The partners have been waiting several years for the chance to put Semglee at the center of their strategies. In 2018, the FDA issued a complete response letter to the first request for approval in light of a lack of data to support the switch between manufacturing plants in India and Malaysia.
Last year, the FDA knocked back a second filing for approval. Biocon said the FDA rejected the filing pending completion of actions needed to address failings identified at its insulin manufacturing site in Malaysia, which generated a Form 483 with 12 observations.
The FDA conducted another inspection of the facility earlier this year. That visit led to a Form 483 with three observations, but did not derail plans to bring Semglee to market this year.
For Sanofi, the introduction of a heavily discounted copycat could accelerate the decline of Lantus. In 2019, US sales of Lantus fell by one-third amid price pressure in the highly competitive diabetes field.
Lantus has faced off-patent competition since Eli Lilly and Boehringer Ingelheim introduced Basaglar at the end of 2016. Basaglar generated sales of $1.1 billion for Lilly in 2019, up 39% on the previous year.