Menu

Biosimilars

Interchangeability V18K30

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.

22119008_l

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.

ESG3

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.

Interchangeability V18K30

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].

04 AA010978

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. 

Clinical trial PainSA V21F04

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.

Approved-V13G05

EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya

Biosimilars/News | Posted 27/05/2025

On 23 May 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 three denosumab biosimilar medicines. The products are Fresenius Kabi’s Bomyntra and Conexxence and Sandoz’s Rolcya.

Bevacizumab 1 V14f01

FDA approves bevacizumab biosimilar Jobevne

Biosimilars/News | Posted 22/05/2025

On 9 April 2025, the US Food and Drug Administration (FDA) has approved Biocon’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab referencing Roche’s Avastin, for intravenous (IV) use.

Bone cells V17C04

EMA recommends nine biosimilars for approval including trastuzumab and denosumab

Biosimilars/News | Posted 11/05/2025

On 25 April 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 nine biosimilar medicines. These include one trastuzumab biosimilar and eight denosumab biosimilars.

Australia flag V13C29

Australia biosimilar approvals in early 2025

Biosimilars/News | Posted 06/05/2025

In early 2025, Australia's medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved several biosimilars, including: Celltrion’s Stoboclo and Osenvelt (denosumab) and Eydenzelt (aflibercept), and Sandoz’s Tyruko (natalizumab).