1. Scrip
  2. >>Focus On Asia
  3. >>South Korea

Inspection Delay Puts Back Hanmi/Spectrum’s Rolontis

US Action Date Now Set For Feb '21

 
• By Jung Won Shin

US FDA defers action on Spectrum’s approval application for neutropenia candidate Rolontis due to pandemic-related difficulties inspecting partner Hanmi’s plant. The action date has been put back although the companies stress no CRL has been issued. 

ReviewStamp_1200x675
FDA Unable To Visit Hanmi’s Bioplant On Travel Restrictions • Source: Shutterstock

The US FDA has had to delay the possible marketing approval of Hanmi Pharmaceutical Co., Ltd. and Spectrum Pharmaceuticals Inc.’s novel long-acting neutropenia drug Rolontis (eflapegrastim) because of the impact of the COVID-19 pandemic on its ability to conduct plant inspections.

While there will be a potential commercial impact from the postponement of a potential launch, the companies said they would...

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
Start Free Trial

Already a subscriber?

More from South Korea

MetaVia Sees Obesity Opportunities Despite Challenging US Market

 
• By Jung Won Shin

Despite new challenges related to obesity drug insurance coverage in the US, MetaVia's CEO is confident in the company's novel contender, which unlike rival GLP-1 therapies doesn’t require dose titration.

Korea Q1 Roundup: Mixed Earnings, Gearing For Possible US Tariffs

 
• By Jung Won Shin

South Korean biopharma companies report a mostly solid first quarter, marked by US growth for original drugs, with several also making preparations for possible US pharma tariffs.

Tech Convergence, Quality Data Needed To Accelerate Korea’s AI-Powered R&D

 
• By Jung Won Shin

AI-powered drug development was a major topic at the recent Bio Korea meeting, where experts discussed how the technology is changing R&D activities and the challenges being faced by Korean firms as they look to catch up with their global competitors.

Celltrion Sees Multiple Biosimilar Opportunities From Trump’s Pricing EO

 
• By Jung Won Shin

Biosimilars giant Celltrion tells shareholders there could be multiple opportunities for its business under US President Donald Trump’s latest executive order on drug pricing.

More from Focus On Asia

ASCO: Lupin Presents Early Data On PRMT5 Inhibitor

 
• By Vibha Ravi

ASCO sees the debut of Lupin’s PRMT5 inhibitor candidate LRNP7457, currently in Phase I studies in India. While no drug with this mechanism of action has been approved anywhere so far, several candidates are in clinical trials.

MetaVia Sees Obesity Opportunities Despite Challenging US Market

 
• By Jung Won Shin

Despite new challenges related to obesity drug insurance coverage in the US, MetaVia's CEO is confident in the company's novel contender, which unlike rival GLP-1 therapies doesn’t require dose titration.

Public Health And Innovation: Addressing Gaps, Pharma’s Role

 
• By Anju Ghangurde

Expert panel including Ashok Venkitaraman, director of the Cancer Science Institute of Singapore, discusses public health challenges and innovations to help address these. Long-acting drugs, intercepting cancer early and “design thinking” by ophthalmologists in India were among the talking points.