A new insulin that is very similar to Sanofi’s Lantus, the best selling insulin in the world, has been recommended for approval in Europe and is pending approval in the United States.
The long-acting basal insulin developed by Boehringer Ingelheim and Eli Lilly and Company received a positive opinion recommending approval by the European Committee for Medicinal Products for Human Use (CHMP). The insulin, called Abasria, has also been submitted for approval to the U.S. Food and Drug Administration, according to Dr. Gwen Krivi, Vice President of Development for Lily.
Abasria is only one new insulin product being developed to try and capture a share of the growing insulin market overall. Sales of insulin reached almost $21 billion annually last year, according to Grand View Research, a market research and consulting company.
“Lilly/BI’s insulin glargine is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycemic control,” the companies said in a statement. “It has the same amino acid sequence as Lantus® (insulin glargine) and was filed through the European Medicines Agency’s (EMA) biosimilar pathway.”
According to Lilly/BI, Abasria is an “insulin glargine product, for the treatment of type 1 and type 2 diabetes” and is the “first biosimilar insulin recommended for approval in the European Union (EU).”
Biosimilar is a regulatory term meaning that the new insulin shares the same “primary amino acid structure” as Lantus, Krivi said.
“Abasria is a biological medicinal product similar to the reference medicinal product Lantus (insulin glargine), authorised in the EU since 9 June 2000,” the EMA said in announcing its recommendation. “Studies have shown Abasria to have a comparable quality, safety and efficacy profile to Lantus (insulin glargine).”
“For patients and health care providers this will provide an option to existing treatments,” Krivi said referring to the competitor to Lantus. Lantus generated almost $8 billion in sales last year and holds 80 percent of the long-acting insulin market worldwide, according to the Chicago Tribune.
The option of Abasria might also drop the cost of long-acting glargine insulin, according to industry analysts who say that, “the new copycat version (is expected) to be priced significantly lower than Lantus, in order to attract patients and healthcare providers.”
If finally approved Abasria won’t be the only new kid on the increasingly crowded market for long-acting insulin in the EU. In March 2013 Danish drug maker Novo Nordisk launched Tresiba in Europe. Novo said clinical trials results indicated Tresiba worked for more than 42 hours per dose, compared to up to 24 hours per dose for Lantus. Additionally, Novo’s trials showed Tresiba caused fewer hypoglycemic episodes than Lantus.
Tresiba suffered a major setback, however, when the FDA delayed approval of the insulin for the U.S. market in March 2013 asking Novo to conduct further tests on potential heart risks from the drug. Tresiba is still awaiting final approval in the U.S.
Tresiba is not the only other rival to Lantus. It’s not even the only rival from Novo Nordisk. In 2006 Novo introduced the long-acting insulin, Levemir. Sales of Levemir, however, failed to capture a significant share of the long-acting insulin market.
So many new long-acting insulin configurations are being developed and launched because the patent on Lantus is set to expire soon. In the United States the Lantus patent expires February 2015 and the drug’s patent expires in Europe in May 2015. By then, Sanofi expects the regulatory decision for marketing authorization for Toujeo, an improved version of Lantus. Abasria, meanwhile, might be delayed from reaching the market until more than a year from now because of litigation brought by Sanofi against and Lilly/BI alleging patent infringements.
Other insulin configurations will likely emerge in the coming years as well, since the market for such drugs will grow at an expected rate of 12.4% for the next six years.
Fueling this growth is a predicted increase globally in the number of people with both type 1 and type 2 diabetes and an increase in the number of type 2 diabetics using insulin. According to Grand View Research, the number of people with diabetes in the world was 366 million three years ago and will grow to an estimated 552 million people in 2030.
“It is estimated that worldwide, by year 2030, one in ten people will suffer from diabetes, giving rise to a huge demand for insulin,” according to drug industry newsletter The Pharma Letter. “China, being the most populous nation in the world, accounts for the largest share of the global diabetic population and eventually turns out as the most lucrative market for insulin manufacturers.”
If trends continue, many of those new insulin users might be type 2 diabetics, according to a June 2014 report from the American Medical Association published in Science Daily. “… use of insulin among patients with type 2 diabetes increased from 10 percent in 2000 to 15 percent in 2010,” the report said, “and out-of-pocket expenditures per prescription increased from a median of $19 to $36.”