Biosimilars
EULAR 2025 RA guidelines streamlined as biosimilar expansion reshapes treatment sequencing
New 9‑point guidance drops prognostic stratification, accelerates biological access as biosimilars and generics drive cost convergence
The European Alliance of Associations for Rheumatology (EULAR) has released its 2025 update of the management recommendations for rheumatoid arthritis (RA), consolidating the previous 11 recommendations into a streamlined set of 9.
FDA approves Ennumo as eighth pegfilgrastim biosimilar
On 7 May 2026, the US Food and Drug Administration (FDA) approved Ennumo (pegfilgrastim-pccg), a biosimilar referencing Amgen’s blockbuster Neulasta. The approval adds an eighth competitor to the US pegfilgrastim biosimilar landscape, further intensifying pricing pressures in the supportive oncology care market.
FDA approves first golimumab biosimilars Immgolis and Immgolis Intri
On 18 May 2026, the US Food and Drug Administration (FDA) approved Immgolis (golimumab-sldi) and Immgolis Intri (golimumab-sldi), marking the first interchangeable biosimilars to Janssen’s (Johnson & Johnson, J&J) anti-tumour necrosis factor (TNF) therapies Simponi and Simponi Aria.
EMA recommends approval for ranibizumab biosimilar Vislyfa
Following the European Medicines Agency’s (EMA) positive opinion of Rexatilux ranibizumab biosimilar in April 2026, on 21 May 2026, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted apositive opinion, recommending the granting of a marketing authorization for Lupin’s ranibizumab biosimilar, Vislyfa, for the treatment of wet macular degeneration.
Biosimilars uptake in Chile: why does it lag behind?
Exploring the barriers to biosimilar adoption in Chile
In Chile, biosimilars uptake is limited, especially for oncology biosimilars. A new study published in GaBI Journal [1] identifies the key barriers to biosimilar adoption in Chile and proposes strategic recommendations to strengthen their value proposition.
FDA approves third interchangeable insulin glargine biosimilar Langlara
On 30 April 2026, the US Food and Drug Administration (FDA) approved Sunshine Lake Pharma’s Langlara (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s Lantus.
EMA recommends approval for ranibizumab biosimilar Rexatilux
On 23 April 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinions, recommending the granting of a marketing authorization for Intas’ ranibizumab biosimilar, Rexatilux, for the treatment of wet macular degeneration.
Japan approves Samsung-Nipro’s ustekinumab biosimilar
In December 2025, Samsung Bioepis and NIPRO announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO' has been granted in Japan.
FDA approves denosumab biosimilar Ponlimsi
On 30 March 2026, the US Food and Drug Administration (FDA) approved Teva Pharmaceuticals’ Ponlimsi (denosumab-adet), a biosimilar to Amgen’s Prolia and Xgeva (denosumab) [1].
Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections
For millions of people at risk of losing their sight, regular eye injections are a crucial but demanding part of treatment. A new study [1] shows that a biosimilar version of aflibercept can be safely given using a pre-filled syringe, a development that could make these injections faster, safer and more convenient.
