Business

IVI Updates RA Value Assessment Model to Include Biosimilars, Sarilumab, JAK Inhibitors

January 9th 2020

By The Center for Biosimilars Staff

The Innovation and Value Initiative (IVI) has updated its existing prototype economic model examining value among rheumatoid arthritis (RA) therapies to include biosimilars.

Novo Nordisk Launches Authorized Generic Insulins, Gets FDA Approval for Fast-Acting Insulin in Pediatric Population

January 7th 2020

By Allison Inserro

Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.

Pfizer Launches Bevacizumab Biosimilar, Zirabev, in the United States

January 6th 2020

By Allison Inserro

Zirabev, which references Avastin, will be priced at a wholesale acquisition cost (WAC) of $61.34 per 10 mg, representing a 23% discount to the WAC of Avastin, Pfizer said.

Spectrum Says Its Novel G-CSF Drug Will Be Reviewed by FDA

January 4th 2020

In late December, Spectrum Pharmaceuticals announced that the FDA has accepted for review a Biologics License Application for eflapegrastim, a novel drug that could, if approved, compete with existing granulocyte colony-stimulating factor (G-CSF) therapies and their biosimilars.

Phase 3 Study Underway for Proposed Etanercept Biosimilar, SCB-808

January 2nd 2020

By Kelly Davio

China-based Clover Biopharmaceuticals announced this week that it has dosed the first patient in a phase 3 clinical study of SCB-808, a proposed etanercept biosimilar referencing Enbrel.

The Top 5 Biosimilars Articles for the Year 2019

December 27th 2019

The Center for Biosimilars® recaps the top stories for the year 2019.

Time for Plans to Shoulder More Risk in Medicare Part D?

December 24th 2019

By Kelly Davio

Among the features of the Part D structure is a federal reinsurance program in which, when a beneficiary reaches the catastrophic threshold in a given year, the government subsidizes 80% of remaining spending for the year. Part D plans pay 15%, and patients pay 5% in this scenario.

Eye on Pharma: Meiji and Dong-A Begin Phase 1 Trial of Proposed Ustekinumab Biosimilar

December 21st 2019

By The Center for Biosimilars Staff

Japan-based Meiji Seika Pharma and Republic of Korea-based Dong-A Socio Holdings announced this month that they have started a phase 1 clinical trial of DMB-3115, a proposed ustekinumab biosimilar referencing Stelara.

The Top 5 Biosimilars Articles for the Week of December 16

December 20th 2019

The Center for Biosimilars® recaps the top stories for the week of December 16, 2019.

WHO Prequalifies Samsung Bioepis' Biosimilar Trastuzumab

December 20th 2019

By Kelly Davio

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.