Biosimilars
FDA approves six denosumab biosimilars
In August and September 2025, the US Food and Drug Administration (FDA) approved six denosumab biosimilars, expanding treatment options for patients with bone health issues.
EMA recommends approval for four biosimilars targeting three therapies
On 24 July 2025, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the granting of a marketing authorization for four biosimilars, including two denosumab biosimilar medicines, an aflibercept biosimilar, and an ustekinumab biosimilar.
FDA approves first interchangeable rapid-acting insulin biosimilar, Kirsty
On 15 July 2025, the US Food and Drug Administration (FDA) approved Biocon Biologics’ Kirsty (insulin aspart-xjhz), a biosimilar to Novo Nordisk’s NovoLog (insulin aspart). This approval designates Kirsty as the first and only interchangeable biosimilar for a rapid-acting insulin, a significant milestone in diabetes treatment access.
ANVISA approves ranibizumab and tocilizumab biosimilars
Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has approved biosimilars for Lucentis (ranibizumab) and Actemra (tocilizumab), expanding treatment access for eye diseases and arthritis.
Argentina approves the first biosimilar agalsidase beta for Fabry disease
Argentina has approved Agalzyme, a biosimilar of agalsidase beta, as the first enzyme replacement therapy for Fabry disease in Latin America, representing a major advance in treatment accessibility for this rare disorder.
Hulio granted US interchangeability status
In May 2025, the US Food and Drug Administration (FDA) announced the decision to grant interchangeability status to Mylan/Biocon’s biosimilar Hulio (adalimumab-fkjp). This biosimilar joins Samsung Bioepis’ Hadlima (adalimumab-bwwd), and a number of other adalimumab biosimilars, as interchangeable products available in the US market [1].
First pembrolizumab similar biological introduced in Paraguay
Paraguay takes major step forward in access to cancer treatments with first pembrolizumab similar biological.
Samsung Bioepis wins Pyzchiva case; Regeneron patent rulings threaten foreign biosimilars
A US court denied J&J's injunction against Samsung Bioepis, clearing Pyzchiva's launch. However, Regeneron's win against Samsung/Formycon set a precedent allowing patent suits against foreign biosimilar makers, raising legal risks for global firms in the contentious US biologicals market.
UK MHRA approves biosimilars Zefylti (filgrastim) and Ahzantive (aflibercept)
In May 2025, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved CuraTeQ’s filgrastim biosimilar Zefylti for neutropenia and PBPC mobilization. Earlier, in February 2025, it approved Formycon/Klinge Biopharma’s aflibercept biosimilar Ahzantive/FYB203 for retinal diseases.
FDA approves ustekinumab biosimilar Starjemza
On 22 May 2025, the US Food and Drug Administration (FDA) approved Bio-Thera Solutions’ Starjemza (ustekinumab-hmny), a biosimilar ustekinumab referencing Janssen/Johnson & Johnson’s Stelara.
