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

Samsung Bioepis Snags Second EU Denosumab Biosimilar – But More Are On The Way

Rivals To Prolia And Xgeva Receive Endorsement From EMA’s CHMP

 
• By Dave Wallace

Samsung Bioepis may be only the second company to obtain an EMA positive opinion for a denosumab biosimilar, but plenty more rivals are on the way with filings of their own.

More rivals are lining up behind Samsung Bioepis and Sandoz (Shutterstock)

Samsung Bioepis has become only the second firm to gain a European Medicines Agency endorsement for its denosumab biosimilars to Prolia and Xgeva, with the agency’s Committee for Medicinal Products for Human Use issuing positive opinions for the company’s rival versions under the names Obodence and Xbryk.

While CHMP positive opinions do not constitute formal approval, the European Commission typically acts to convert them into pan-European marketing...

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

Making The UK A Leading Biosimilar Launch Destination – Realistic Or Optimistic?

 
• By Urtė Fultinavičiūtė

Experts discussed the UK government’s commitment to make the country a desirable destination for companies to launch their biosimilars at a recent conference hosted by Medicines UK.

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

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

 
• By Urtė Fultinavičiūtė

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 Dean Rudge

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.

More from Generics Bulletin

MSN Labs Swerves 2026 US Entresto Patent Ahead Of Separate July 15 Expiry

 
• By Dean Rudge

Novartis has filed an immediate appeal after a US district court ruled that MSN Labs would not infringe one of its key patents shielding its $7.8bn Entresto brand, and denied the originator injunctive relief.

UK Sitagliptin Prices Shoot Up In June

 
• By Dave Wallace

Multiple strengths of sitagliptin saw average price increases that topped our rundown of UK generic pricing data in June.

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

 
• By Urtė Fultinavičiūtė

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