Memorandum

Mylan 1Q17 – FDA submission for biosimilar insulin glargine expected imminently; No updates on oral insulin or biosimilar rapid-acting insulin programs – May 12, 2017

Executive Highlights

  • FDA submission of Biocon-partnered biosimilar insulin glargine “on track” and expected soon.
  • No updates on Biocon-partnered phase 3 oral Insulin Tregopil program or progress of preclinical Biocon-partnered biosimilar insulin aspart and insulin lispro.

Mylan recently provided its 1Q17 update in a call led by controversial CEO Ms. Heather Bresch. As has been the case in the company’s past several earnings calls, the discussion focused largely on US drug pricing and the company’s response to the ongoing EpiPen pricing controversy, leaving very little room for discussion of Mylan’s diabetes portfolio. Management briefly highlighted that the development of its Biocon-partnered biosimilar insulin glargine (Sanofi’s Lantus) “remains on track.” The product was submitted to the EMA in 3Q16 and Mylan’s US filing for the product is expected “shortly” according to Biocon’s 1Q17 update, behind the previous timeline of April 2017 (and the timeline before that of a 4Q16 filing date). If approved, this product could the third-to-market biosimilar insulin glargine following Lilly/BI’s Basaglar (launched in the EU as Abasaglar in late 2015; launched in the US in December 2016) and Merck’s MK-1293 (submitted to the EMA in late 2015 and the FDA in mid 2016). The product is already available in Japan and emerging markets. We’ll be interested to see how Mylan/Biocon’s product will be competitively priced and positioned relative to Lilly/BI’s Basaglar 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.

We heard no updates on Mylan’s two preclinical Biocon-partnered rapid-acting insulin products: biosimilar insulin aspart (Novo Nordisk’s NovoLog) and biosimilar insulin lispro (Lilly’s Humalog), both of which were previously highlighted in the company’s 4Q16 update as promising future drivers of growth. We haven’t heard any updates from either Mylan or Biocon since the initial announcement of the development program in 2013 and hope these two candidates are still priorities for Mylan. We additionally heard nothing on Mylan’s Biocon-partnered oral Insulin Tregopil. Biocon highlighted in its recent 1Q17 update that it has filed a Clinical Trial Application (CTA) in India for a pivotal phase 3 study of the candidate, but Mylan has made no mention on the candidate since the same 2013 announcement. All of this said, our confidence in the future robustness of the rapid-acting insulin market and the feasibility of oral insulins as a whole is measured. The currently sluggish rapid-acting insulin market face significant challenges from increased competition within the field as other, far more advanced candidates enter the competitive landscape – namely Novo Nordisk’s Fiasp (US approval expected by the end of 2017) and Adocia’s phase 3-ready BioChaperone Lispro (currently looking for a new partnership, after Lilly’s surprising termination of the licensing agreement). Additionally, Sanofi’s biosimilar insulin lispro will reach the market many years before Mylan/Biocon’s candidates – Sanofi submitted the product to the EMA for regulatory review in Europe in September 2016 and will likely be submitted in the US soon.  Furthermore, oral insulin is a challenging proposition due to dosing challenges, lower bioavailability, and narrower therapeutic range, not to mention the potential of newer drugs such as SGLT-2 inhibitors and GLP-1 agonists to delay insulin initiation.

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