Coherus Biosimilar Used ‘Scientific Justification’ To Skip Switch Study, Still Get Interchangeability With Lucentis

Information on mechanism of action, pharmacokinetics, immunogenicity and toxicity convinced the US FDA there was no risk in terms of safety or diminished efficacy of switching between Cimerli and the reference product, Genentech’s eye drug Lucentis.

Eye data binary
Cimerli was not subject to a 'switching' study prior to earning an interchangeability nod • Source: Shutterstock

Coherus BioSciences and partner Bioeq provided “sufficient justification” that Cimerli (ranibizumab-eqrn), a biosimilar of Genentech’s macular degeneration treatment Lucentis (ranibizumab), will produce the same clinical result in any given patient for each condition of use, the US Food and Drug Administration said in deciding to award an interchangeability designation in the absence of a “switching” study.

This scientific justification took into account information on mechanism of action, pharmacokinetics, immunogenicity and toxicity, the FDA said in a...

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

More from Biosimilars

Biocon’s Denosumab Biosimilar Approved In The UK As Competition Grows In Europe

 

Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.

Pertuzumab Leader Henlius Receives EU Accreditation For Production Lines

 
• By 

Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.

Alvotech Boosts Packaging Abilities With Ivers-Lee Acquisition

 
• By 

Alvotech has acquired long-time partner Ivers-Lee to expand its in-house capacity for assembly and packaging ahead of key planned biosimilar launches in 2025, strengthening operational control and supporting global growth.

Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By 

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

More from Products

Bakers And Fishermen: How Biosimilars Manufacturers Are Bridging The Skills Gap

 
• By 

At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.

US Federal Circuit Says No To Teva And Viatris On Remanded Invega Sustenna Appeal

 
• By 

Just days after Viatris was frustrated in its attempts to challenge IP protecting Janssen’s Invega Trinza, the US Federal Circuit has rejected the firm’s and Teva’s bid to invalidate a patent shielding the one-month version of the brand, Invega Sustenna.

Lupin And Zentiva Throw Hat Into The Ring On Biosimilar Cimzia

 
• By 

The announcement by Lupin and Zentiva of a development and commercialization deal on a certolizumab pegol biosimilar candidate has revealed a new potential challenger to Alvotech’s AVT10, previously thought to be the only Cimzia rival in development.