1. Scrip
  2. >>Focus On Asia

Tweaks In Indian Biosimilar Guidelines Target ‘Residual Risk’

 
• By Anju Ghangurde

India's latest set of guidelines for biosimilars seeking market authorization in the country has specified additional post marketing study requirements to "further" reduce the "residual risk" of similar biologics.

India has issued new guidelines for biosimilars, which largely build on the 2012 guidance in the area, and note that additional safety data "may need to be collected" after market approval through a pre-defined single arm study of "generally more than 200 evaluable patients" and compared to historical data of the reference product.

"The study should be completed preferably within two years of the marketing permission/manufacturing license unless otherwise justified," it says.

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 Focus On Asia

Is Zydus’s Agenus Deal Opportunistic Or Strategic?

 
• By Vibha Ravi

Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?

Citeline Japan Awards 2025 - Enter Now!

 
• By Ian Haydock and Lisa Takagi

The 14 July deadline for the Citeline Japan Awards 2025 in Tokyo is approaching fast, so here's a reminder to take a look at the categories and criteria and be sure to get those submissions in by this date. Sponsorship opportunities and tables for the event are also available.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Pharma’s Space Trails Entering Transformative Era - Keytruda’s Been There

 
• By Anju Ghangurde

Merck and Lilly are among the leading pharma players using space-based research to power drug development. From reusable satellites to process drugs in low earth orbit to biomanufacturing labs experts discuss R&D opportunities in the starry canvas above.

More from Scrip

BioNTech To Buy mRNA Rivals CureVac

 
• By Andrew McConaghie

The $1.25bn buyout is a simple deal for BioNTech, bringing new mRNA R&D and manufacturing capacity while also ending a bothersome patent dispute.

Is Zydus’s Agenus Deal Opportunistic Or Strategic?

 
• By Vibha Ravi

Will Zydus’s acquisition and licensing deal with Agenus turn out to be a strategic move towards building an oncology portfolio or an opportunistic one driven by a venture capital mindset?

How AstraZeneca Aims To Stay Ahead In Lupus As New Competition Looms

 
• By Andrew McConaghie

The company has established the efficacy of its biologic Saphenlo in systemic lupus erythematosus but is now investing across modalities to stay ahead of rivals.