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News

  • 16/09/2025
  • Press Release

STADA Expands Specialty Biosimilars Portfolio through European Approval for Afiveg (aflibercept)

  • European Commission grants STADA marketing authorization for Afiveg® (aflibercept) pre-filled syringes and vials, marking STADA’s second approved biosimilar in ophthalmology
  • Launch in lead market Germany is scheduled following expected loss of EU protection for the Eylea® reference product in Q4 2025
  • STADA Global Specialty Head Ian Henshaw: “We look forward to building on the credibility we have built in the specialty ophthalmology sector through our biosimilar ranibizumab to expand patient access to aflibercept.”


Bad Vilbel, Germany – 16 September 2025 – STADA has expanded its Specialty portfolio of approved biosimilars in Europe to eight molecules. The European Commission has granted STADA marketing authorization for Afiveg® (aflibercept), a biosimilar to the Eylea® reference product, as 40mg/ml solution for injection in pre-filled syringes and vials.

Approval from the Commission follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) positive opinion in June 2025 recommending approval of Afiveg to treat multiple retinal diseases, including neovascular (wet) age-related macular degeneration (AMD)[1]. STADA anticipates introducing the biosimilar in its lead market, Germany, following expected loss of exclusivity for the Eylea reference brand during the fourth quarter of 2025.

Afiveg is STADA’s second ophthalmology biosimilar approved in Europe, joining Ximluci (ranibizumab), which STADA now offers in more than 20 countries, holding top-three market positions, measured by revenues in the 12 months ended June 2025, in 15 European countries. Afiveg is also the Group’s eighth approved biosimilar overall. It adds to approvals for epoetin zeta in nephrology and oncology, teriparatide in bone health, adalimumab, tocilizumab and ustekinumab in immunology; bevacizumab in oncology; and ranibizumab in ophthalmology.

“We look forward to building on the credibility in the specialty ophthalmology sector we have built with biosimilar ranibizumab to expand patient access to aflibercept in treating retinal conditions that affect millions of people,” stated STADA’s Global Specialty Head, Ian Henshaw. “We will work closely with ophthalmologists, clinicians and other stakeholders to improve patient access to biologic treatment options as a trusted supplier of effective, high-quality biosimilars.”

Specialty was the fastest-growing of STADA’s three business segments in the first half of 2025, with adjusted constant-currency revenues increasing by 18% to €486 million. This rise was largely attributable to a strong performance and penetration of STADA’s ustekinumab biosimilar launched from July 2024, reinforced by continued broad-based growth of the group’s in-market biosimilars portfolio. Growing patient uptake of innovative nephrology and neurology brands also contributed to the double-digit Specialty revenues growth. 


[1]Afiveg | European Medicines Agency (EMA)

About STADA Arzneimittel AG
STADA Arzneimittel AG is headquartered in Bad Vilbel, Germany. The company focuses on a three-pillar strategy consisting of consumer healthcare products, generics and specialty pharma. Worldwide, STADA Arzneimittel AG sells its products in over 100 countries. In financial year 2024, STADA achieved group sales of € 4,059 million and adjusted constant-currency earnings before interest, taxes, depreciation and amortization (adj. cc EBITDA) of € 886 million. As of 31 December 2024, STADA employed 11,649 people worldwide.

Additional information for journalists
STADA Arzneimittel AG - Media Relations
Stadastrasse 2-18, 61118 Bad Vilbel - Germany
Phone: +49 (0) 6101 603-165
E-Mail: [email protected]

Additional information for capital market participants
STADA Arzneimittel AG - Investor & Creditor Relations
Stadastrasse 2-18, 61118 Bad Vilbel – Germany
Phone: +49 (0) 6101 603-4689
Fax: +49 (0) 6101 603-215
E-mail: [email protected]