Business

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.

Biosimilar Competition Has Led to "Marked Reductions" in Biologics' Net Prices, Study Finds

December 19th 2019

By The Center for Biosimilars Staff

The promise of biosimilars is that these subsequent-entry products can reduce the cost of biologic therapy by offering lower-priced alternatives that do not compromise efficacy or safety. An additional benefit is that the presence of competition in the marketplace can also drive down costs for originator products, or at least curb price growth, though to what degree biosimilars have had such an impact on originator biologics in the US market has not been fully elucidated.

Federal Appeals Court Strikes Down ACA Individual Mandate, Sends Law Back to Lower Court

December 19th 2019

By Allison Inserro

A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.

Do Biosimilars Have a Role in US Plan to Allow Imports?

December 18th 2019

By Allison Inserro

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.