Products

Date: 2015-12-16

Type of information: Product launch

Product name: Abasria® (EU)/Basaglar™ (USA) - LY2963016

Compound: insulin glargine (biosimilar version of Lantus®)

Therapeutic area: Metabolic diseases

Action mechanism:

• biosimilar/insulin. Basaglar™  is a follow-on insulin to Lantus®. It is a long-acting insulin with an amino acid sequence identical to Lantus, another U-100 insulin glargine.
• In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three compounds representing several of the largest treatment classes.

Company: Eli Lilly (USA - IN) Boehringer Ingelheim (Germany)

Disease: treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above

Latest news:

• • On December 15, 2016, Eli Lilly and Boehringer Ingelheim announced  that Basaglar™ (insulin glargine injection 100 units/mL) is available by prescription in the U.S. Basaglar™ will be available by prescription from retail and mail order pharmacies across the U.S.  As the top three pharmacy benefit managers have selected Basaglar™ for their formularies, it is expected to be widely covered by commercial insurance plans. In addition, Lilly and Boehringer Ingelheim will offer a Basaglar™ savings card for eligible people.
• • On December 16, 2015, the FDA approved Basaglar® (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Basaglar® is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. A 505(b)(2) application was submitted for Basaglar® that relied, in part, on the FDA’s finding of safety and effectiveness for Lantus® (insulin glargine injection) to support approval. The applicant demonstrated that Basaglar® was sufficiently similar to Lantus® to scientifically justify reliance, and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. The Basaglar-specific data included two clinical trials enrolling 534 and 744 patients with type 1 and 2 diabetes mellitus respectively. Dosing of Basaglar® should be individualized based on the patient’s needs. Basaglar® is administered subcutaneously once daily at any time of day, but at the same time every day.
• Basaglar® should not be used during episodes of hypoglycemia (low blood sugar) or in patients with hypersensitivity to insulin glargine or one of its ingredients. The most common adverse reactions associated with Basaglar in clinical trials were hypoglycemia, allergic reactions, injection site reactions, pitting at the injection site (lipodystrophy), itching, rash, edema (fluid retention) and weight gain. Basaglar received tentative approval from the FDA on Aug. 18, 2014, and is now being granted final approval. Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no “reference product” for a proposed biosimilar product.
• • On September 10, 2014, the European Commission granted marketing authorisation for Eli Lilly and Boehringer Ingelheim’s insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. Lilly/Boehringer Ingelheim’s insulin glargine product is the first insulin treatment approved through the European Medicines Agency’s biosimilar pathway and the fourth diabetes product approved in the EU from the Lilly-Boehringer Ingelheim Alliance. It received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on June 26, 2014.
• The marketing authorisation for the Alliance's insulin glargine product is based upon a comprehensive clinical data programme, which showed it has similar efficacy and safety compared to the currently marketed insulin glargine product in people with type 1 and type 2 diabetes. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes.
• While 'Abasria' is an approved name in Europe, it's not necessarily approved in other regions. Lilly and Boehringer Ingelheim are targeting a global trade name for the Alliance's insulin glargine product, which will be announced at a later date. Lilly/Boehringer Ingelheim’s insulin glargine product will be manufactured by Lilly, which has been manufacturing insulin since 1923. This history gives Lilly extensive expertise, insights and knowledge in the insulin space, enabling it to provide high quality medicines to diabetes patients worldwide.
• • On August 18, 2014, the FDA has granted tentative approval for Basaglar™ (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. Basaglar™ has the same amino acid sequence as the currently marketed insulin glargine product and was tentatively approved for use with KwikPen®, a pre-filled dosing device. 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. Under the Drug Price Competition and Patent Term Restoration Act ("Hatch Waxman"), 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.
• The tentative approval is based, in part, on results from Lilly and Boehringer Ingelheim's extensive clinical development program for the alliance's insulin glargine product. The submission included results from pharmacokinetic and pharmacodynamics studies, as well as Phase III studies in people with type 1 and type 2 diabetes. The Basaglar™ new drug application was filed through the FDA's 505(b)(2) regulatory pathway, which allows the agency to consider the efficacy and safety of the existing insulin glargine product. Lilly-Boehringer Ingelheim's insulin glargine product (Abasria®) is considered a biosimilar in other regions such as Europe, where it recently received a positive recommendation. Basaglar™ is not considered a biosimilar in the United States.
• • On 26 June 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Abasria®, 100 Units/ml, solution for injection intended for the treatment of diabetes mellitus. Abasria® is a biological medicinal product similar to the reference medicinal product Lantus® (insulin glargine), authorised in the EU since 9 June 2000. Studies have shown Abasria® to have a comparable quality, safety and efficacy profile to Lantus® (insulin glargine). A pharmacovigilance plan for Abasria® will be implemented as part of the marketing authorisation.
• • On December 20, 2013, Eli Lilly and Boehringer Ingelheim have announced that the FDA has accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin. The NDA was filed through the 505(b)(2) regulatory pathway, which allows the FDA to reference their previous findings of safety and efficacy data for an already-approved insulin glargine product, in addition to the studies of LY2963016. Lilly and Boehringer Ingelheim designed the comprehensive development program for LY2963016 in order to meet the regulatory standards of clinical and nonclinical safety, efficacy and quality. In addition to comparative pharmacokinetic and pharmacodynamic studies, the NDA submission includes results from Phase III studies that were conducted in patients with type 1 and type 2 diabetes, using a currently marketed insulin glargine product as the active comparator. In July 2013, the companies announced the marketing authorisation application (MAA) for LY2963016 was accepted for review by the European Medicines Agency (EMA).
• • On July 8, 2013, Eli Lilly and Boehringer Ingelheim have announced that the companies\' marketing authorisation application (MAA) for LY2963016, an investigational basal (long-acting) insulin for the treatment of type 1 and type 2 diabetes, has been accepted for review by the European Medicines Agency (EMA). LY2963016 has been filed through the EMA\'s biosimilar pathway. Lilly and Boehringer Ingelheim have studied LY2963016 in a comprehensive clinical development program in order to meet the highest standards of safety, efficacy and quality. In addition to pharmacokinetic and pharmacodynamic studies, Phase III studies in patients with type 1 and type 2 diabetes have been conducted and results submitted, using currently marketed insulin glargine as the active comparator.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2014-08-18/2015-12-16

UE authorization: 2014-09-10

Favourable opinion UE: 2014-06-26

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

• • On September 28, 2015, Eli Lilly announced that the group has entered into a settlement agreement to resolve patent litigation with Sanofi regarding Basaglar®. As a part of the agreement, Lilly and its alliance partner, Boehringer Ingelheim, will have the ability to launch Basaglar in the U.S. on December 15, 2016. Under the terms of the agreement, Sanofi has granted Lilly a royalty-bearing license so Lilly can manufacture and sell Basaglar® in the Kwikpen® device globally. Further details regarding the settlement are confidential. The FDA tentatively approved Basaglar® in August 2014. With this resolution, Lilly plans to request final approval of Basaglar from the FDA. Eli Lilly expects to launch Basaglar in the U.S. in December of 2016.

 

Is general: Yes