Memorandum

FDA grants full approval for Lilly/BI’s biosimilar insulin glargine Basaglar – December 18, 2015

Executive Highlights

  • Lilly/BI’s biosimilar insulin glargine received full FDA approval with an indication for adults and children with type 1 diabetes and adults with type 2 diabetes.
  • As per the terms of Sanofi and Lilly’s patent lawsuit settlement agreement, Basaglar will not launch until December 15, 2016.

Lilly just announced the FDA approval of its long-awaited biosimilar insulin glargine formulation Basaglar, partnered with BI. The full approval comes as no surprise, as the agency had tentatively approved Basaglar in August 2014. The official approval was delayed by Sanofi’s intellectual property lawsuit against Lilly, triggering a 30-month stay that could have delayed full approval to mid-2016. However, Sanofi and Lilly announced a settlement agreement in September 2015, allowing the final FDA approval process to proceed earlier than expected. Under the terms of the settlement, Lilly/BI can launch Basaglar in the US on December 15, 2016 and Lilly will pay undisclosed royalties to Sanofi in exchange for the license to disputed patents for Lantus (insulin glargine). Basaglar is the first “biosimilar” insulin product to be approved via the 505(b)(2) regulatory pathway and, despite the delay, is expected to be the first biosimilar insulin to launch in the US. While not technically considered a biosimilar by the FDA, it has an identical amino acid sequence to Lantus and has demonstrated clinical equivalence in phase 3 trials. The 505(b)(2) pathway will be consolidated with the newer “official” biosimilar pathway in 2020. Mylan/Biocon and Merck/Samsung Bioepis also have biosimilar versions of insulin glargine in phase 3 development and Sanofi’s revised guidance in its 3Q15 update assumes that three biosimilar insulin glargine products will be available by 2018. Lilly/BI’s biosimilar has already launched in several ex-US markets (under the brand name Abasaglar) and is typically priced at a 15%-20% discount relative to Lantus in those markets. While these discounts are lower than some had hoped, we wonder if they will be steeper in the US given the significantly higher costs for branded basal insulin analogs compared to other markets. That said, the biosimilar development process is much more expensive than that for small molecule generics, suggesting that the 50%-80% discounts seen with generics may be an unrealistic expectation for biosimilars.

  • Basaglar received an identical indication to Lantus (indicated for adults and children with type 1 diabetes and adults with type 2 diabetes), although other aspects of the label were dissimilar. Basaglar will be offered exclusively as Lilly’s KwikPen injection device while Lantus is offered in 10 mL vials as well as in Sanofi’s SoloStar pen and OptiClik injection device. Interestingly, Basaglar’s label includes a contraindication against use during episodes of hypoglycemia, and warnings for hypokalemia and fluid retention and heart failure when used with TZDs, none of which are included in the Lantus label. However, unlike the Lantus label, there is no warning against use in insulin pumps or intravenous administration. The adverse reactions listed for Basaglar include all those listed for Lantus, plus edema and weight gain. We wonder if the single delivery option will negatively affect patient preference when selecting Basaglar over Lantus.
  • Despite the label similarities, Lilly did not receive (or pursue) an “interchangeable” designation that would allow pharmacists to substitute a product for the reference product without consulting the prescribing physician. An interchangeable biosimilar product must meet additional standards demonstrating similarity to the reference product. Lilly’s decision not to pursue this designation is consistent with its previous statements that it would position Basaglar like a new insulin product rather than as a “generic” to Lantus.
  • We’ve heard great optimism that biosimilar insulin glargine will help patients facing higher insulin costs. At IDF earlier this month, Dr. Matthew Riddle suggested that of all the new formulations of insulin newly on the market, Basaglar will help the greatest number of patients with its presumably lower price. In fact, he estimated that 50% of all patients with type 2 diabetes would benefit from biosimilar insulin glargine, compared to just 25% of patients benefiting from the reduced hypoglycemia and flatter profile seen with next-generation basal insulin (such as Novo Nordisk’s Tresiba [insulin degludec] and Sanofi’s Toujeo [U300 insulin glargine]). We imagine even incremental discounts for Basaglar compared with Lantus will benefit underserved populations, particularly the uninsured or underinsured patients who pay for insulin out-of-pocket.

Close Concerns Questions

Q: Will patients and providers perceive Basaglar as equally safe and clinically equivalent to Lantus?

Q: Will Lilly follow through on its promise to market Basaglar as it would any new branded insulin? If so, how will payers react?

Q: What might the discounts look like for Basaglar in the US?

Q: Will pharmacy benefits managers pursue exclusive formulary contracts with either Basaglar or Lantus in pursuit of greater rebates?

Q: Will government payers consider switching coverage to Basaglar to cut costs?

Q: When can Lilly begin negotiations with payers? Does the patent lawsuit settlement agreement prevent Lilly from engaging in payer negotiations until the product is allowed to launch in December 2016?

 

-- by Helen Gao, Sarah Odeh, Emily Regier, and Kelly Close