Biosimilars

Samsung Bioepis wins Pyzchiva case; Regeneron patent rulings threaten foreign biosimilars

Biosimilars/General | Posted 30/07/2025

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)

Biosimilars/News | Posted 30/07/2025

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

Biosimilars/News | Posted 22/07/2025

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.

EMA recommend approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars

Biosimilars/News | Posted 10/07/2025

On 19 June 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 six biosimilars, including four aflibercept biosimilar medicines, an ustekinumab biosimilar, and a pegfilgrastim biosimilar.

FDA approves Hadlima and Otulfi as interchangeable biosimilars

Biosimilars/News | Posted 30/06/2025

In May 2025, the US Food and Drug Administration (FDA) has designated Samsung Bioepis and Organon’s Hadlima (adalimumab-bwwd) autoinjectors and prefilled syringes as the fifth interchangeable Humira biosimilar. Separately, Formycon’s Otulfi (ustekinumab-aauz) became the fourth interchangeable Stelara biosimilar.

EC approves three biosimilars, 14 more await final authorization

Biosimilars/News | Posted 20/06/2025

The European Commission (EC) granted marketing authorization for three biosimilars: Amgen’s Pavblu, CuraTeQ Biologics’s Dyrupeg, and Celltrion’s Qoyvolma, between March and June 2025.

Reaching ESG goals in pharmaceutical development

Biosimilars/Research | Posted 10/06/2025

A recent article published in GaBI Journal, ‘Aligning environmental, social, and governance to clinical development: moving towards more sustainable clinical trials,’ [1] explores how regulators, pharmaceutical companies, and clinical researchers can align with environmental stewardship, social diversity, and equitable governance (ESG) goals for the efficient conduct of clinical trials, including those of biologicals and biosimilars.

What is the future for the US biosimilar interchangeability designation

Biosimilars/Research | Posted 05/06/2025

The evolving regulatory landscape of biosimilars and the concept of ‘interchangeability’ in the US, is explored in the GaBI Journal article, ‘US interchangeability designation: are we ready to cut the Gordian knot?’ [1].

FDA approves denosumab biosimilars Stoboclo and Osenvelt

Biosimilars/News | Posted 05/06/2025

On 28 February 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Stoboclo and Osenvelt (denosumab-bmwo), a denosumab biosimilar referencing Amgen’s Prolia and Xgeva respectively.

Biosimilar clinical efficacy studies: are they still necessary?

Biosimilars/Research | Posted 27/05/2025

A paper published in Drugs, explores the evolution in biosimilars regulatory thinking which is now moving away from the default requirement for clinical efficacy studies (CES) for approval [1]. This follows the release of European Medicines Agency's ‘draft reflection paper on a tailored clinical approach in biosimilar development’ [2] published on 1 April 2025.