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Details:
Soliqua is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. It is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Product Name: Soliqua
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2023
Iran Expo
Not Confirmed
Contact SupplierDetails:
Participants were randomized to switch from their prior insulin to either Soliqua once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
Lead Product(s): Insulin Glargine,Lixisenatide
Therapeutic Area: Endocrinology Product Name: Soliqua
Highest Development Status: UndisclosedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2021
Iran Expo
Not Confirmed
Contact Supplier
Details:
Civica plans to produce three insulin biosimilars – glargine, lispro and aspart – each of which will be available both in vials and prefilled pens, and to ensure redundancy of supply, Ypsomed will provide injector dosing pens from their manufacturing facilities.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Peptide
Partner/Sponsor/Collaborator: Civica Rx
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 31, 2023
Details:
Biosimilar insulin glargine is the most significant opportunity in the company's current pipeline. Recent estimated U.S. sales of long acting insulin glargine (Glaricon) are approximately $10 billion annually, according to IQVIA, although manufacturer reported sales are less.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Glaricon
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: HEC Group
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 31, 2022
Details:
The first study, which the FDA reviewed, suggested that the HEC insulin glargine product would be biosimilar to US-approved Lantus® (the reference biologic) in terms of meeting the study's pharmacokinetics (PK) and pharmacodynamics (PD) endpoints.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: HEC-Glargine
Highest Development Status: Phase IProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
Civica will produce three insulins – glargine, lispro and aspart (biologics corresponding to, and interchangeable with, Lantus, Humalog and Novolog respectively) – each of which will be available both in vials and prefilled pens.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Insulin Glargine-Generic
Highest Development Status: PreclinicalProduct Type: Peptide
Partner/Sponsor/Collaborator: GeneSys Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing March 03, 2022
Details:
The acquisition of biosimilars assets of Viatris significantly strengthens BBL’s position in providing affordable access to patients through its portfolio in diabetes, oncology, immunology and other non-communicable diseases including Semglee (Insulin Glargine-yfgn).
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Semglee
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Biocon
Deal Size: $3,335.0 million Upfront Cash: $2,335.0 million
Deal Type: Acquisition February 28, 2022
Details:
The Semglee® (insulin glargine injection), is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus and is packaged in prefilled pens.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Semglee
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Biocon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Details:
Decisions reaffirm Viatris' ability to provide patient access to interchangeable for the reference brand, Lantus®, allowing for substitution at the pharmacy counter. Semglee® is indicated to help control high blood sugar with type 1 diabetes and type 2 diabetes.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Semglee
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2021
Details:
Under the terms of this agreement, Tabuk Pharmaceuticals will hold the marketing authorisation for select speciality products including Glaricon and be responsible to register, importing, and promoting them in Saudi Arabia and other Middle East countries.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Glaricon
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Biocon
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 07, 2021
Details:
Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Semglee
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Biocon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 28, 2021
Details:
At the Biosimilar Biological Product Development Type II meeting the FDA provided positive feedback on the clinical and Chemistry, Manufacturing and Controls advancement of company's biosimilar insulin glargine that was consistent with our expectations.
Lead Product(s): Insulin Glargine
Therapeutic Area: Endocrinology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
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