Formycon Gets Date For Aflibercept Filing In US

US FDA Offers June 2024 Action Date For Coherus-Partnered FYB203 Eylea Biosimilar

Formycon has announced a June 2024 FDA action date for its FYB203 proposed aflibercept biosimilar rival to Eylea, which is due to be marketed by Coherus in the US.

Eyes US flag
Formycon is eyeing a June 2024 FDA action date for FYB203 • Source: Shutterstock

Formycon says it has now received a target action date in next June from the US Food and Drug Administration for its FYB203 proposed biosimilar rival to Eylea (aflibercept), which is due to be marketed in the US by Coherus Biosciences.

“Formycon and its license partner Klinge Biopharma announce that the FDA has accepted the biologics license application for FYB203, 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

Lupin Launches Generic Version Of Lilly’s Discontinued Glucagon In The US

 

Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By 

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.

Kashiv Joins Forces With MS Pharma In MENA For Omalizumab

 
• By 

Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.

Civica Pairs With Fresenius Kabi To Supply Stelara Biosimilar

 
• By 

US non-profit Civica has announced a partnership with Fresenius Kabi to supply a Stelara rival, revealing pricing details for its exclusive unbranded version of Kabi’s Otulfi biosimilar that will be available from the start of next year.

More from Products

Amgen Welcomes Evolving Biosimilar Guidelines As Competitive Advantage

 
• By 

Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

A Duke-Margolis working group is developing ideas to enable non-profit firms to seek US FDA approval for new indications for off-patent medicines. The former acting commissioner thinks citizen petitions might be the fastest route.

Kashiv Joins Forces With MS Pharma In MENA For Omalizumab

 
• By 

Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.