European committee recommends approval for generic long-acting insulin
The US Food and Drug administration (FDA) has approved an insulin inhaler for managing diabetes mellitus. Mannkind’s Afrezza is aimed at reducing the need for patients to inject themselves with insulin so frequently. In Europe, the Committee for Medicinal Products for Human Use has recommended that a ‘biosimilar’ long-acting insulin be approved, although this product is the subject of a patent infringement lawsuit in the US.
Inhalable insulin has been a target for pharma companies for several years. Pfizer’s Exubera was approved in 2006, but was withdrawn in January 2008 because of its high cost and concerns over links to lung cancer. Mannkind has taken three attempts to get Afrezza approved by the FDA, after being sent back to complete further clinical trials. While the FDA has approved Afrezza, the decision comes with significant limitations. It still requires patients to inject a long-acting insulin as well as the inhaler, and cannot be used by patients with chronic lung diseases like asthma.
Eli Lilly and Boehringer-Ingelhiem’s long acting Abasria insulin injection has the same amino acid sequence as Sanofi’s Lantus (insulin glargine), which means that it is classed as a biosimilar for regulatory purposes in Europe. Abasria is the first insulin product to pass through Europe’s biosimilars regulatory pathway. Because of differing definitions, it is not classed as a biosimilar in the US, which led Sanofi to file a patent infringement lawsuit against Lilly in January.