EMA Okays LixiLan Plus Biosimilars for Osteoporosis and Diabetes

November 11, 2016

The European Medicines Agency (EMA) has given the green light to a combination of insulin glargine (Lantus, Sanofi) and the GLP-1 agonist lixisenatide (Adylxin, Sanofi), for the treatment of type 2 diabetes. If approved, which is usually a formality within around 60 days, the EU will be the first major market for this product.

Known as LixiLan during clinical trials, the fixed-ratio combination of insulin glargine, a basal insulin analogue, and lixisenatide will be available as a solution for injection (insulin 100 units/mL with lixisenatide 33 or 50 µg/mL) and will be known as Suliqua.

"Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycemic control when this has not been provided by metformin alone or metformin combined with another oral glucose-lowering medicinal product or with basal insulin," says the EMA's Committee for Medicinal Products for Human Use (CHMP).

The same combination product suffered a setback in the United States this summer when it was delayed for 3 months after the Food and Drug Administration (FDA) requested more details about the pen delivery device.

In the European Union, Suliqua will compete with a similar product from Novo Nordisk called Xultophy , a combination of the GLP-1 agonist liraglutide (Victoza) and the long-acting insulin degludec (Tresiba). Known as IDegLira in clinical trials, approval of this latter product has also been delayed in the United States.

The CHMP has also recommended for approval a fast-acting version of insulin aspart, to be known as Fiasp (Novo Nordisk), which will be available as a solution for injection (100 units/mL) and is indicated for use as the bolus component of basal-bolus therapy in combination with basal insulin and for continuous subcutaneous insulin infusion via an insulin pump for the treatment of type 1 and type 2 diabetes in adults.

Novo Nordisk says it developed Fiasp as a mealtime insulin "with an earlier and greater glucose-lowering effect" than its conventional insulin aspart.

CHMP Also Recommends Biosimilars for Diabetes, Osteoporosis

The CHMP has also recommended for approval three new biosimilar products for two endocrine conditions, type 2 diabetes and osteoporosis.

One is another biosimilar version of insulin glargine for the treatment of diabetes in adults, adolescents, and children aged 2 years and above, to be known as Lusduna (Merck Sharp & Dohme).

"Studies have shown Lusduna to have comparable quality, safety, and efficacy to the reference product Lantus," states EMA.

The first biosimilar version of Lantus, manufactured by Lilly, was approved in the European Union 2 years ago and in the United States last December.

Also approved are two biosimilar versions of teriparatide, a parathyroid-hormone product for the treatment of osteoporosis.

To be known as Movymia (STADA Arzneimittel) and Terrosa (Gedeon Richter), they will be specifically indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and for the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture.

Teriparatide is the active aminoterminal fragment of human parathyroid hormone, and both Movymia and Terrosa are "highly similar" to the reference product Forsteo/Forteo (Lilly), the agency states. Both will be available as a solution for injection (20 µg/80 µL).

Studies have shown Movymia and Terroso to have comparable quality, safety, and efficacy to Forsteo, says the EMA.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and on Facebook.


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