1. Generics Bulletin
  3. >>Biosimilars

Biosimilars Statistical Guidance Reflects Early Development Approach

 
• By Sue Sutter

US FDA's long-awaited draft guidance on statistical approaches for analytical similarity testing appears to echo what agency has been telling biosimilar product sponsors in private about ranking and testing reference product attributes according to criticality.

Identical twins
Statistically, they are the same.

A new US FDA draft guidance on statistical approaches for analytical similarity testing of biosimilars addresses issues, such as the number of product lots tested and equivalence margins, that have arisen in some of the early application reviews.

On the whole, however, the guidance may not break much new ground, particularly for those biosimilar sponsors that have already had one-on-one discussions with FDA about analytical similarity data assessments.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Biosimilars

Samsung Bioepis Heads For Spin Out To Unlock ‘Hidden Value’

 
• By Dean Rudge

Samsung Biologics will retain solely its significant CDMO business, eliminating a perceived conflict of interest, as it pursues an equity spin-off for its biosimilars business Samsung Bioepis.

Amgen And Samsung Soliris Biosimilars Skirt UK Infringement On Claim Construction

 
• By Dean Rudge

Just days after a court in Canada barred Amgen’s Soliris biosimilar until patent expiry in 2027, a UK High Court has handed a favorable ruling to the California-based firm and Samsung Bioepis, ruling that their products do not infringe a patent shielding the branded treatment for paroxysmal nocturnal hemoglobinuria.

Formycon Hopes Stelara Biosimilar Sales To Pull Through FY2025 As Q1 Revenues Slump

 
• By Urtė Fultinavičiūtė

Formycon said it predicted low earnings in the first quarter of 2025, after enjoying milestone payments last year. Now, the pressure is on the growing biosimilars portfolio to pull the company through this year.

Gedeon Richter Feels Biosimilar Model ‘Is Looking For An Equilibrium’

 
• By Dean Rudge

Gedeon Richter’s CEO weighed in on the pricing landscape for biosimilars as the firm admitted the market for biosimilar denosumab was set to be more crowded than it had initially anticipated.

More from Products