On 30 May 2025, Australia’s Therapeutic Good’s Administration (TGA) approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), across 5 products…
On 30 May 2025, Samsung Bioepis announced that it has received marketing approval in South Korea for its second denosumab biosimilar, Xbryk™, biosimilar to Amgen’s Xgeva® (denosumab)…
On 28 May 2025, Russia’s GxP News reported that the Russian Ministry of Health approved Russian biotechnology company Biocad’s Pertuvia™, biosimilar to Roche’s Perjeta® (pertuzumab), making it…
On 27 and 28 May 2025, Bristol Myers Squibb announced that its subcutaneous formulation of Opdivo® (nivolumab), Opdivo® SC (nivolumab co-formulated with recombinant human…
Three months after Cytiva subsidiary media supplier HyClone Laboratories filed a motion to quash a subpoena issued to it by Amgen in the context of denosumab BPCIA litigation between Amgen and Fresenius Kabi…
On 28 May 2025, Alvotech and Advanz Pharma announced that they have entered a supply and commercialisation agreement to expand their existing partnership to cover three additional biosimilar candidates…
On 27 May 2025, Formycon and Fresenius Kabi announced the Canadian launch of FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). The biosimilar is available in both IV and…
On 27 May 2025, Bio-Thera Solutions and Hikma Pharmaceuticals announced that the US FDA has approved BAT2206, marketed as Starjemza® (ustekinumab-hmny), biosimilar to J&J/Janssen’s…
On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Good’s Administration (TGA) across 4 products…
On 27 May 2025, Samsung Bioepis announced that it has secured expanded interchangeability designation in the US for its Hadlima™ (adalimumab-aaty), biosimilar to AbbVie’s Humira®…
On 25 May 2025, Biocon Biologics announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Yesintek®, biosimilar to….
On 29 May 2025, Hengrui Pharma announced that China’s National Medical Products Association (NMPA) granted approval to its antibody drug conjugate trastuzumab rezetecan for use as a…
On 23 May 2025, AstraZeneca and Daiichi Sankyo announced that Canada’s Drug Agency has recommended a Time-Limited Reimbursement for Enhertu® (trastuzumab deruxtecan). According…
On 23 May 2025, Bayer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a label extension for Eylea™ 8mg (aflibercept…
On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively. Wyost® and Jubbonti® are the first and only…
At its May 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for three denosumab biosimilars: Sandoz’s Rolcya®…