Tag Archives: glargine

Thoughts on CONCLUDE (H2H Tresiba vs. Toujeo T2DM Basal-only Trial)

Novo Nordisk presented results at EASD from CONCLUDE, its Tresiba vs. Toujeo T2DM basal-only H2H study, and announced the results in a press release. While the trial failed to demonstrate a statistically significant benefit in the primary endpoint (severe or BG-confirmed symptomatic hypoglycemia), key secondary outcomes showed a clear benefit favoring Tresiba. It is a bit ironic that since the primary endpoint was not met, no conclusions can be made from the CONCLUDE secondary outcomes. Below, FENIX provides thoughts on the trial including a winners & losers analysis.

This content is for Read Less members only.
Register

Already a member? Log in here

Sanofi Initiates New Toujeo vs. Tresiba T1DM CGM Study (inRange)

A CT.gov record has been observed for a new Sanofi-sponsored T1DM Ph4 Toujeo vs. Tresiba H2H non-inferiority trial utilizing CGM. Of note, the trial, called “inRange,” will evaluate time-in-range (TIR) as the primary outcome. Below, FENIX provides thoughts on this new trial in the context of the ongoing basal insulin saga between Sanofi and Novo Nordisk.

This content is for Read Less members only.
Register

Already a member? Log in here

Biocon’s Glargine Facility Receives EU GMP Certification

Yesterday, Biocon announced it received EU GMP certification from EMA for its integrated insulin facility in Malaysia, which was inspected in May 2019. Biocon’s Malaysian facility manufactures insulin glargine and rh-insulin. Below, FENIX provides additional thoughts on the EU GMP certification in the context of the recent FDA 483 observations and impending Biocon/Mylan bs-glargine US launch.

This content is for Read Less members only.
Register

Already a member? Log in here

Biocon CY Q2 ’19 (FY Q1 ’20) Earnings Update

Biocon hosted its CY Q2 ’19 (FY Q1 ’20) earnings call and briefly discussed its biosimilar insulin programs including bs-glargine and bs-aspart. Of note, Biocon recently initiated three Ph1 PK/PD studies for its rHI portfolio. Below, FENIX provides highlights and insights from the call.

This content is for Read Less members only.
Register

Already a member? Log in here

Biocon Malaysian Facility Receives Additional 483 Observations From FDA

Biocon has received an additional twelve 483 observations from an FDA inspection of Biocon’s Malaysian facility. The 483 observations were a result of an FDA pre-approval inspection for the bs-glargine product; however, the company did not provide any specific details. No result was found during a search of FDA’s inspection citations. According to Biocon, the inspection is not anticipated to impact plans for US commercialization. Below, FENIX provides context and insight regarding these 483 observations.

This content is for Read Less members only.
Register

Already a member? Log in here