With the ongoing national discussion on drug pricing and increasing scrutiny particularly focused on insulin, Lilly released its 2018 Annual Transparency Report which included detailed information on Humalog pricing. Recall, Lilly recently announced the creation of a Humalog authorized generic with a list price 50% lower than Humalog. Below, FENIX provides an overview and insights on Lilly’s drug pricing transparency including Lilly’s apparent strategy to direct legislative pressure onto PBMs.

A new trial evaluating Sanofi’s biosimilar aspart (SAR341402) has been observed on CT.gov. The trial, called GEMELLI X, is an open-label, crossover design comparing SAR341402 vs. NovoLog in 184 T1DM adults who are also on glargine U100. The name of Sanofi’s Ph3 program is clever in that Gemelli is a type of pasta derived from the Italian word for “twins.” The “X” in this trial appears to reference the crossover design. Below, FENIX provides thoughts on the trial as well as insight into Sanofi’s potential strategy to delay filing until after March 23, 2020 thereby allowing for regulatory submission via the 351k biosimilar pathway.

Novo Nordisk announced it has submitted EMA and FDA applications for the use of Fiasp in adolescents and pediatrics based on results from the Onset 7 study (children down to age 1). According to the press release, Novo anticipates a response from EMA later in 2019 and an FDA decision in “early 2020.” Below, FENIX provides insight into the Fiasp pediatric filings as well as context from Lilly’s upcoming URLi pediatric study (Pronto-Peds).

MannKind hosted its Q4 ’18 earnings call and provided updates to its Afrezza business including commercial and clinical activities. Below are highlights and insights from the call.