Memorandum

Mylan 3Q16 – Biosimilar insulin glargine submitted to EMA; FDA submission expected by end of year – November 23, 2016

Executive Highlights

  • Management highlighted the EMA-submission for its Biocon-partnered biosimilar insulin glargine (Sanofi’s Lantus).
  • Submission of biosimilar insulin glargine to the FDA is “on track” to occur by 4Q16.

Mylan recently provided its 3Q16 update in a call led by the controversial CEO, Ms. Heather Bresch. Unsurprisingly, the call focused largely on EpiPen pricing in response to the recent public outcry, leaving little room for discussion of Mylan’s diabetes portfolio. Management did, however, highlight the recent EMA-submission for its Biocon-partnered biosimilar insulin glargine (Sanofi’s Lantus). The product is already available in Japan, where it is marketed exclusively by Biocon. We don’t know how it’s doing yet although during its recent 3Q16 update Biocon management was quite optimistic about the potential for this biosimilar insulin in other markets based on the success of the Japanese launch. Mylan’s EMA submission comes on schedule with the 4Q16 timeline established in the company’s 2Q16 update. FDA submission for the biosimilar product is also expected by this time, and Mylan management stated that this remains “on track” and that Mylan continues to “generate additional data” and work with the FDA to “establish an interchangeable pathway” for the company’s biosimilar program. We were encouraged to hear Ms. Bresch note the significant unmet need in affordable diabetes care, particularly in light of the projection that 15% of the world’s pharmaceutical spending will be on diabetes medicines by 2020. Mylan/Biocon’s biosimilar insulin glargine offers a more affordable option that the companies believe will be very popular with patients. We’ll be interested to see how Mylan/Biocon’s product will be competitively priced and positioned relative to Lilly/BI’s similar insulin glargine Basaglar (due to launch in the US December 15) and originator Lantus, especially for the formularies that have excluded Lantus in favor of Basaglar for 2017 (such as CVS Health and UnitedHealthcare). Additionally, the safety and quality assurance of biosimilar insulin – particularly from companies without longstanding experience and reputations in the insulin market – will likely remain a question mark for some patients and providers.

In its 1Q16 update Mylan highlighted the interim data from the phase 3 INSTRIDE 1 trial (in which the company’s biosimilar met its primary and secondary endpoints in type 1 diabetes patients) and indicated that the data from the equivalent INSTRIDE 2 trial in type 2 diabetes patients would be available in June 2016. However, Mylan’s call provided no updates on these trials, although both still have expected completion dates of June 2016 according to ClinicalTrials.gov. Furthermore, Mylan did not share any updates on the development of its Biocon-partnered development programs for oral Insulin Tregopil, biosimilar insulin aspart (Novo Nordisk’s NovoLog), or biosimilar insulin lispro (Lilly’s Humalog). We have heard almost no updates on these products – from either Mylan or Biocon – since the initial announcement of the development program in 2013.

 

-- by Abigail Dove, Helen Gao, and Kelly Close