Memorandum

Mylan and Biocon file biosimilar insulin glargine with the EMA – November 3, 2016

Executive Highlights

  • Mylan has announced the EMA-submission of its Biocon-partnered biosimilar insulin glargine (Sanofi’s Lantus), which if approved, would likely be the third biosimilar insulin glargine product to hit the European market (following Lilly/BI’s Abasaglar and Merck’s MK-1293).

Mylan just announced that the company has submitted its Biocon-partnered biosimilar insulin glargine (Sanofi’s Lantus) to the EMA for approval in Europe. This news comes in time with what Mylan shared during the company’s 2Q16 update – submission to both the FDA and the EMA were slated for 4Q16. If approved, Mylan/Biocon’s product could be the third-to-market biosimilar insulin glargine in Europe, following Lilly/BI’s Abasaglar (launched in late 2015) and Merck’s MK-1293 (submitted to the EMA in late 2015). The product is already available in Japan, marketed exclusively by Biocon in that region, and in fact Biocon management was quite optimistic about the potential for this biosimilar insulin in other markets based on the progress of the Japanese launch during the company’s recent 3Q16 update. We’re very curious to see how the basal insulin market plays out in the next few years. On the one hand, Mylan is armed with vast experience with generics and we imagine this expertise will be helpful in promoting the biosimilar. On the other, the insulin commercial market faces significant challenges overall and Mylan/Biocon’s biosimilar product will be competing with more-established biosimilars from companies with a larger foothold in the US diabetes market, as well as Sanofi’s gold standard originator product Lantus. We’ve also heard concerns about the potential safety and quality assurance of biosimilar insulins, given the complex manufacturing process for biologics compared to small molecule drugs – we imagine that some providers and patients may prefer biosimilar insulin glargine manufactured by a company with a long history of experience with insulin (Lilly) or at least a huge presence in diabetes care (Merck). We are interested to see what deals they try to strike with payers, who may not be as concerned.

We’re still awaiting Mylan/Biocon’s FDA submission. There’s a chance the product will face the same fate as Basaglar (US name for Abasaglar) and MK-1293 – Sanofi filed patent infringement lawsuits against Lilly and Merck, respectively. Basaglar’s launch was delayed to December 15, 2016. No settlement has yet been announced between Lilly and Merck for MK-1293. From our point of view, there is such tremendous need for more affordable insulin therapies given the continuously rising rates of diabetes in the US, which also means there’s room for multiple effective products to be successful and offer greater patient choice. Of course, safety is a key consideration for these biosimilar products and many patients continue to do very well with Lantus – we’re thus disappointed with decisions like CVS Health’s and UnitedHealthcare’s to unilaterally switch all of its members from Lantus to a biosimilar. We don’t expect decisions such as these will necessarily fix the current insulin pricing woes that are reaching a fever pitch – it’s a problem that will likely require a multifaceted solution involving payers, providers, manufacturers, and policymakers. Regardless, these biosimilars are all products to watch closely going forward – see our insulin competitive landscape for more.

  • Mylan/Biocon have two phase 3 trials ongoing for their biosimilar insulin: INSTRIDE 1 for adults with type 1 diabetes and INSTRIDE 2 for adults with type 2 diabetes, both designed to demonstrate non-inferiority vs. Lantus. According to ClinicalTrials.gov, both studies were scheduled to complete in June 2016, though Biocon management was very positive that interim data from the phase 3 program supports US and European submissions.

 

-- by Payal Marathe, Helen Gao, and Kelly Close