1. Generics Bulletin
  2. >>Products
  3. >>Biosimilars

What’s Next? Five Things To Look Out For In June

First Ophthalmic Biosimilar To Launch In US; Alvotech Merger To Close

 
• By Dean Rudge

In June, Medicines for Europe will host its annual and legal affairs conferences in Barcelona, while on the commercial side Hikma’s CEO Siggi Olafsson is to resign from the London-listed company.

What's Next Image
June is a busy month for industry • Source: Informa

History is to be made in June with the launch of the first biosimilar anti-VEGF product for ophthalmic conditions in the US: Samsung Bioepis’ Byooviz (ranibizumab-nuna) referencing Genentech’s Lucentis (ranibizumab) blockbuster. (Also see "FDA Approves First Ophthalmic Biosimilar With Samsung Bioepis’ Lucentis Rival" - Generics Bulletin, 20 September, 2021.)

Approved by the FDA in September last year, Byooviz had been expected to begin shipping in the US by the end of 2021, ahead of a European launch in early 2022 as supplementary

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

Fresenius Kabi Lauds Tocilizumab Momentum As ‘Intense’ Transfer To mAbxience Continues

 
• By Dean Rudge

Fresenius Kabi continued to reap the rewards of its fledgling commercial Biopharma business in the first quarter, as the firm eyes further growth for its tocilizumab biosimilar in the US and Europe in the second half of 2025.

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Generics Bulletin Explains: The Landscape For Denosumab Biosimilar Competition

 
• By Dave Wallace

One of the biggest biologic loss-of-exclusivity opportunities of the year is almost upon us, as biosimilars developers across the world get ready to launch rivals to Amgen’s denosumab brands Prolia and Xgeva. Generics Bulletin offers a rundown of some of the major contenders and how they view the market.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

More from Products

After Jazz, Hikma Agrees $50m Settlement For ‘Most’ Xyrem ‘Pay-For-Delay’ Claims

 
• By Dean Rudge

Hikma said it would admit no wrongdoing or liability after reaching a preliminary settlement agreement over illicit ‘pay-for-delay’ claims involving its US version of Xyrem “that protects the company’s interests and provides clarity to our stakeholders.”

CIOMS Welcomes Draft Report Feedback On The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

Viatris Pens Aprepitant Settlement Agreement After Kabi Loses Initial Patent Case

 
• By Dean Rudge

Viatris will look to introduce generic versions of Heron Therapeutics’ aprepitant brands, Cinvanti and Aponvie, around three years before patent expiry after settling litigation with the originator. Other court cases remain ongoing.