Mylan/Biocon’s Semglee approved as second-to-market biosimilar basal insulin in Europe and Australia – March 28, 2018

Mylan announced this week that Biocon-partnered Semglee (biosimilar insulin glargine) has been approved in the EU and Australia. This news follows a positive CHMP opinion in January. Mylan plans to launch Semglee in European markets in 2H18 and in Australia “later this year.”

Semglee now stands to be the second-to-market biosimilar basal insulin in both Europe and Australia, after Lilly/BI’s Abasaglar, another biosimilar formulation of glargine (Sanofi’s Lantus). This is a significant milestone for Mylan and Biocon, as it represents the first agent in the companies’ joint portfolio to be approved in the EU.

Mylan/Biocon’s biosimilar insulin glargine is already available in Japan and in select emerging markets, including the UAE. The candidate is currently under review at FDA – Mylan submitted an NDA in 4Q17 and a decision for the US market is expected between August and October 2018, although this may be complicated by Sanofi’s patent infringement lawsuit.

Basaglar has been an impressive commercial success to-date, with Lilly’s reported revenue from the product in 2017 at $434 million (BI’s sales are not public), and we think it’s paving the way for future biosimilar basals as HCPs become more familiar and comfortable with equivalent safety/efficacy. In addition to Semglee, Merck’s Lusduna (also biosimilar glargine) could reach the market in the next couple years, creating a three-product biosimilar basal class. Sanofi has received FDA approval for the first biosimilar rapid-acting insulin, and Admelog (biosimilar lispro) is expected to launch in the US sometime this year.

Despite this momentum, we anticipate that Mylan/Biocon may face greater challenges in marketing their biosimilar insulin since neither company has meaningful experience or credibility in insulin manufacturing. Concerns over safety and quality assurance may result, especially after recent research from Drs. Lutz Heinemann and Alan Carter found highly-variable insulin concentration in real-world U100 vials.


-- by Abigail Dove, Payal Marathe, and Kelly Close