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Biosimilars

TNFa Crystal Structure V18K17

EULAR 2025 RA guidelines streamlined as biosimilar expansion reshapes treatment sequencing

Biosimilars/Research | Posted 03/07/2026

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. 

Pegfilgrastim V16B19

FDA approves Ennumo as eighth pegfilgrastim biosimilar

Biosimilars/News | Posted 03/07/2026

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.

TNFa Crystal Structure V18K17

FDA approves first golimumab biosimilars Immgolis and Immgolis Intri

Biosimilars/News | Posted 22/06/2026

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. 

Blue eye with data points

EMA recommends approval for ranibizumab biosimilar Vislyfa

Biosimilars/News | Posted 12/06/2026

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.

Cancer Cell V13I20

Biosimilars uptake in Chile: why does it lag behind?

Biosimilars/Research | Posted 05/06/2026

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. 

Insulin 1 V13C03

FDA approves third interchangeable insulin glargine biosimilar Langlara

Biosimilars/News | Posted 05/06/2026

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.

Age-related macular degeneration V15b19

EMA recommends approval for ranibizumab biosimilar Rexatilux

Biosimilars/News | Posted 25/05/2026

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.

Plaque Psoriasis Stada v24K25

Japan approves Samsung-Nipro’s ustekinumab biosimilar

Biosimilars/News | Posted 06/05/2026

In December 2025, Samsung Bioepis and NIPRO announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO' has been granted in Japan.

Bone cells V17C04

FDA approves denosumab biosimilar Ponlimsi

Biosimilars/News | Posted 24/04/2026

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].

78 MD002368

Biosimilar aflibercept (AVT06) pre-filled syringe promises safer, faster eye injections

Biosimilars/Research | Posted 16/04/2026

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.