Memorandum

Lilly/BI’s biosimilar insulin glargine approved in Europe – September 10, 2014

Executive Highlights

  • Lilly/BI announced this morning that the European Commission has granted approval for the companies’ biosimilar insulin glargine formulation; Lantus patent protection expires in 2015.
  • This is the first biosimilar insulin approval in Europe; the formulation was tentatively approved in the US in August but full approval is stalled by ongoing Sanofi litigation.

Earlier today, Lilly and BI announced that the European Commission has approved the companies’ insulin glargine formulation, formerly known as LY2963016. This makes the product the first insulin ever approved in Europe under the EMA’s biosimilar drug approval pathway. Lilly/BI announced the EMA’s acceptance of the marketing authorization application for the insulin glargine formulation back in July of last year, meaning that the review took upwards of one year. Sanofi’s patent protection for Lantus only expires in mid-2015, so Lilly/BI’s formulation cannot be launched any time this year. The product will be available as a pre-filled pen (KwikPen) and in cartridges for a reusable pen.

The reimbursement environment in Europe for diabetes drugs has become very challenging in recent years, with particular pressure from the German G-BA and IQWiG authorities, whose decisions to only reimburse a number of drugs at generic levels have caused many manufacturers to withdraw drugs from the German market. There is great interest and motivation on patient advocacy in Europe and we expect to see more patient focus on reimbursement there to preserve access to new therapies - we look forward to watching this movement as we believe regulatory agencies in the EU may be more responsive there than elsewhere.

The price of insulin analogs has shot up in recent years (as was discussed in depth at the recent Barbara Davis Center Keystone Conference), and some providers are looking to biosimilars as a means to make high-quality analogs more affordable for more patients. However, biosimilars will not lead to the same level of price decreases as the genericization of small molecule drugs, as biological products such as insulin require a great deal of resources and expertise to manufacture. For this reason, Lilly management has stated on multiple occasions (including the company’s 2014 ADA pipeline update call) that the company expects biosimilar insulins to behave more like a branded market.

  • It remains to be seen how patients and providers will view the coming wave of biosimilar insulins. Dr. Philip Home (Newcastle University, Newcastle upon Tyne, UK) spoke on this topic at this year’s Barbara Davis Center conference in Keystone, CO. He suggested that it is difficult for physicians and perhaps even regulators to directly monitor the manufacturing quality of a biosimilar, and that the reputation of the manufacturer will serve as a stand-in for quality in many peoples’ minds. This is good news for Lilly/BI due to Lilly’s insulin legacy (Lilly will be manufacturing the insulin glargine product), but perhaps not as positive for other prospective biosimilar insulin manufacturers such as Biocon/Mylan that may not be as familiar in the US and EU.
  • Across the Atlantic from the EMA, the FDA “tentatively” approved the insulin glargine formulation on August 18th, but Lilly/BI cannot launch the product due to ongoing Sanofi patent litigation. The lawsuit resulted in a 30-month stay of full approval, which would push the earliest possible US launch date into mid-2016 unless the case is ruled in Lilly/BI’s favor before then.
  • Lilly/BI and other companies continue to note that “biosimilar” is a regulatory designation, and that the FDA technically does not recognize Lilly/BI’s formulation as a biosimilar. However, its amino acid sequence is identical to that of Sanofi’s Lantus, and as Dr. Julio Rosenstock (Dallas Diabetes and Endocrine Center, Dallas, TX) noted at an ADA presentation on the formulation, the product is functionally a biosimilar. We hope that the differences in terminology between the US and EU are not a cause for confusion with providers.
  • The approved brand name for the insulin glargine product in Europe is Abasria, while the provisional trade name in the US is Basaglar. However, the press release states that companies plan to pursue a single global trade name for the product, which it suggested it would announce at an unspecified later date.
  • Other companies with biosimilar insulin glargine formulations in development include Merck/Samsung Bioepis and Biocon. Two phase 3 trials for Merck/Samsung Bioepis’ candidate MK-1293 are currently recruiting (ClinicalTrials.gov Identifiers: NCT02059161 and NCT02059187). Biocon has a biosimilar insulin glargine on the market in over ten countries (mostly in the developing world) and is “on track” to begin a global phase 3 program in partnership with Mylan (see our Biocon F4Q14 report).

 

-- by Manu Venkat and Kelly Close