Biosimilars
Reaching ESG goals in pharmaceutical development
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
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
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?
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.
EMA recommends approval for three denosumab biosimilars: Bomyntra, Conexxence, and Rolcya
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.
FDA approves bevacizumab biosimilar Jobevne
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.
EMA recommends nine biosimilars for approval including trastuzumab and denosumab
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 biosimilar approvals in early 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).
Australia approves ustekinumab biosimilar Uteknix
Australia’s medicines regulatory agency, the Therapeutic Goods Administration (TGA), approved Alvotech/Cipla’s ustekinumab biosimilar, Uteknix, on 11 February 2025.
Chinese biosimilars go global: growth, partnerships, and challenges
Chinese biosimilars have gained global traction, with companies like Henlius and Bio-Thera securing international approvals. Despite challenges, China’s innovation and partnerships position it as a key biopharmaceutical player.
