Biosimilars

FDA approves first interchangeable ranibizumab biosimilar Ranluspec

Biosimilars/News | Posted 04/08/2026

On 2 June 2026, the US Food and Drug Administration (FDA) has approved Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar referencing Roche/Genentech’s Lucentis (ranibizumab). Ranluspec is the first interchangeable biosimilar referencing Lucentis approved in both single-dose vial and single-dose prefilled syringe presentations across its two strengths (0.3 mg and 0.5 mg).

Medicines for Europe calls for Biotech Act reforms to address ‘biosimilar void’

Biosimilars/General | Posted 04/08/2026

Medicines for Europe has published a comprehensive position paper outlining critical reforms needed in the European Biotech Act to address what it describes as a growing ‘biosimilar void’ threatening patient access, healthcare sustainability, and Europe's strategic autonomy in biotechnology.

Biosimilar interchangeability: a necessary fix, but not a silver bullet

Biosimilars/Research | Posted 04/08/2026

Beyond the FDA, state laws and PBM practices remain key hurdles to broader substitution.

As the US biosimilar market continues to mature, policymakers and regulators are grappling with whether changes to the US Food and Drug Administration's (FDA) interchangeability standards can unlock greater competition and lower biological drug costs. A new analysis published in the American Journal of Managed Care concludes that while reforming these standards is a necessary first step, it is unlikely to be sufficient on its own to transform the biosimilar landscape.

EMA recommends approval for biosimilar Denosumab Ascend and pegfilgrastim Nylaspeg

Biosimilars/News | Posted 22/07/2026

On 25 June 2026, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of marketing authorizations (MA) for two biosimilar medicines: Ascend’s Denosumab Ascend and Qilu’s pegfilgrastim Nylaspeg.

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.

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.

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.

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 a positive 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?

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.

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.