Memorandum

FDA grants “tentative approval” to Lilly/BI’s insulin glargine formulation Basaglar – August 18, 2014

Executive Highlights

  • Lilly/BI announced that the FDA has granted “tentative approval” for Basaglar (insulin glargine); full approval is dependent on the outcome of Sanofi’s intellectual property litigation.

Somewhat sooner than expected, Lilly/BI announced today that the US FDA has granted “tentative approval” for its insulin glargine formulation LY2963016, which will be marketed under the brand name Basaglar. The “tentative” nature of the approval is due to a 30-month stay resulting from Sanofi’s intellectual property lawsuit against Lilly, which pushes the timeline for full approval back to mid-2016 unless the case is ruled in Lilly’s favor. Even with the delay, Basaglar is likely to be the first “biosimilar” insulin on the US market – while Basaglar is not technically designated as a biosimilar by the FDA, its amino acid sequence is identical to that of Sanofi’s Lantus, and Dr. Julio Rosenstock (Dallas Diabetes and Endocrine Center, Dallas, TX) was clear during his ADA presentation on the product that, “scientifically, [Basaglar] is a biosimilar.” Basaglar was submitted to the FDA in December under the 505(b)(2) regulatory pathway, which allowed for the inclusion of clinical data on Lantus (the reference product) as well as results from the phase 3 ELEMENT 1 and ELEMENT 2 trials demonstrating equivalent efficacy and safety with Basaglar compared to Lantus. Clearly a big win for Lilly/BI, this announcement should benefit patients by giving them access to an expanded range of basal insulin options; more competition in the basal insulin market is also widely expected to lead to lower costs, though Lilly management has said that it plans to market Basaglar as it would any new branded product. It also remains to be seen how much confidence patients, providers, and payers will have in the safety and clinical equivalence of biosimilar insulins and how powerful the effect of brand loyalty to Lantus will be.       

  • Sanofi’s 2Q14 update provided some insight into the timeline of the litigation against Lilly. According to management, a pre-trial “Markman” hearing, in which a judge determines the meaning of words in patent claims that are under dispute, is scheduled for this fall. The actual trial is scheduled to take place in September 2015, and barring a “summary judgment” (when a judge issues a ruling without a full trial), a ruling would likely not occur before 2016. This continues to be baffling to us that a ruling would be so far out of the calendar.
  • This candidate, which will be marketed under a different trade name in Europe, recently received a positive CHMP opinion from the EMA; a final decision (likely an approval) is expected toward the end of this month. Abasria is officially categorized as a biosimilar in Europe, and if approved, it would be the first biosimilar insulin to reach the EU market.
  • Other companies with biosimilar insulin glargine formulations 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).

Close Concerns Questions

Q: What potential exists for the Sanofi/Lilly lawsuit to settle before mid-2016?

Q: How will Lilly/BI price Basaglar? How will availability of Basaglar change “bundling” to various payers?

Q: How will Lilly/BI balance the marketing of Basaglar as similar to Lantus vs. as its own branded insulin? Will the label include both Lantus data and Basaglar data? How will corporate symposia and other provider marketing efforts highlight Basaglar vs. Lantus data?

Q: What marketing claims will the FDA allow Lilly/BI to make regarding similarity to Lantus?

Q: How will patients and providers perceive Basaglar relative to Lantus? Will Basaglar be viewed as a novel insulin or a generic alternative to Lantus?

Q: Why is Basaglar not considered a “biosimilar” in the US? Will the FDA ever use the term “biosimilar?”

Q: How will payers perceive Lilly’s drug portfolio once Basaglar comes to market? Is Lilly more likely to win single-source formulary contracts once Basaglar launches?

Q: Will Lilly pursue a GLP-1/insulin combination with Basaglar and dulaglutide?

Q: What other names besides “Basaglar” were considered? Was “Basaglar” Lilly/BI’s first choice?

--by Emily Regier, Adam Brown, and Kelly Close