Spectrum Gears Up To File Rolontis, Stresses Patient Access

Biosimilars of Amgen's blockbuster Neulasta pose a competitive threat to long-acting GSF Rolontis, but the company has experience with group purchasing and notes that large oncology clinics will make more revenue by providing higher-priced products.

Healthcare Business and Medical Services Concept

Spectrum Pharmaceuticals Inc. stressed its ability to offer access to its novel long-acting granulocyte colony stimulating factor (G-CSF) Rolontis, through patient assistance programs, based on positive data from two Phase III studies – ADVANCE and RECOVER – that pave the way for a biologic license application (BLA) filing in the fourth quarter.

Rolontis (eflapegrastim, SPI-2012) is being positioned to take on the market of Amgen Inc.'s blockbuster Neulasta (pegfligrastim) for the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from R&D

How Teva Is Expanding Innovation To Fuel ‘Pivot To Growth’

 

Teva VP-global R&D and chief medical officer Eric Hughes talked to Scrip about building the company’s innovative pipeline in its growth-acceleration phase.

2025’s Biggest Launches – Half-Year Progress Report

 

Trial setbacks and extra regulatory scrutiny have hit the progress of some new drugs towards expected approvals this year, but early successes have boosted the commercial prospects of others. Fears of disruption from changes at the US FDA are so far unfounded.

Will AstraZeneca Reach Summit And Be A PD-1xVEGF Player?

 
• By 

Rumor mill suggests a $15bn licensing deal for ivonescimab is in the offing.

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By 

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

More from Scrip

Compass Pathways’ Antidepressant Advances In An Increasingly Tough Psychedelic Market

 
• By 

Psychedelics appear to be in vogue after years of being relegated to alternative medicine. But investor pushback after the highly anticipated release of Phase III trial data by Compass Pathways reveals an increasingly high bar for development.

Eolo Pharma Advances In Obesity With Thermogenesis Approach

 
• By 

Emerging Company Profile: Early-stage biotech Eolo will seek cash and deals for its novel obesity drug SANA after positive Phase I results for weight loss, lean muscle mass preservation and fat mass reduction.

BioMarin’s Roctavian Continues to Shine In Hemophilia A Despite Commercial Woes

 

Roctavian shows durable bleed control and safety over five years, but high costs and access hurdles limit its commercial outlook.