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The Food and Drug Administration has granted a "tentative" approval to the insulin glargine product developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly, according to an announcement by the companies issued Aug. 18.
The indication for the basal insulin, which has the trade name Basaglar, is to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adult and pediatric patients with type 1 diabetes.
"With a tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement," the Lilly statement says. Under the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman act), "the FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier," according to the statement.
The statement says that Basaglar "has the same amino acid sequence as the currently marketed insulin glargine product."
In Europe, where the product is considered a biosimilar, the Committee for Medicinal Products for Human Use (CHMP), has issued a positive recommendation for this product. The CHMP is a division of the European Medicines Agency, the equivalent of the FDA; the EMA defines a biosimilar as "a biological medicine that is similar to another biological medicine" that has already been authorized for use in Europe.
Sanofi’s insulin glargine was approved in 2000 and is marketed as Lantus.
The Food and Drug Administration has granted a "tentative" approval to the insulin glargine product developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly, according to an announcement by the companies issued Aug. 18.
The indication for the basal insulin, which has the trade name Basaglar, is to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adult and pediatric patients with type 1 diabetes.
"With a tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement," the Lilly statement says. Under the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman act), "the FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier," according to the statement.
The statement says that Basaglar "has the same amino acid sequence as the currently marketed insulin glargine product."
In Europe, where the product is considered a biosimilar, the Committee for Medicinal Products for Human Use (CHMP), has issued a positive recommendation for this product. The CHMP is a division of the European Medicines Agency, the equivalent of the FDA; the EMA defines a biosimilar as "a biological medicine that is similar to another biological medicine" that has already been authorized for use in Europe.
Sanofi’s insulin glargine was approved in 2000 and is marketed as Lantus.
The Food and Drug Administration has granted a "tentative" approval to the insulin glargine product developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly, according to an announcement by the companies issued Aug. 18.
The indication for the basal insulin, which has the trade name Basaglar, is to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adult and pediatric patients with type 1 diabetes.
"With a tentative approval, the FDA has determined that Basaglar meets all of the regulatory requirements for approval, but it is subject to an automatic stay of up to 30 months as a result of litigation filed by Sanofi, claiming patent infringement," the Lilly statement says. Under the Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman act), "the FDA cannot give final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly earlier," according to the statement.
The statement says that Basaglar "has the same amino acid sequence as the currently marketed insulin glargine product."
In Europe, where the product is considered a biosimilar, the Committee for Medicinal Products for Human Use (CHMP), has issued a positive recommendation for this product. The CHMP is a division of the European Medicines Agency, the equivalent of the FDA; the EMA defines a biosimilar as "a biological medicine that is similar to another biological medicine" that has already been authorized for use in Europe.
Sanofi’s insulin glargine was approved in 2000 and is marketed as Lantus.
