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…
Bio-Thera/Hikma’s Biosimilar Ustekinumab Approved in US
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Approval Alert: Sandoz’s Aflibercept Biosimilars Second to be Approved in Australia
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…
Samsung Bioepis’ and Celltrion’s Adalimumab Biosimilars Granted Expanded US Interchangeability
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®…
Biocon’s Biosimilar Ustekinumab UK Approved
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….
China’s NMPA Approves Hengrui Pharma’s Trastuzumab Rezetecan
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…
AstraZeneca & Daiichi Sankyo’s Enhertu® Receives Time-Limited Reimbursement Recommendation from Canada’s Drug Agency
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…
Regeneron/Bayer’s Aflibercept 8mg Recommended in EU with Expanded Treatment Interval and Approved in China
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…
GSK’s Nucala® (Mepolizumab) FDA Approved for COPD
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…
CHMP Recommends Approval of Denosumab Biosimilars for Fresenius & Sandoz
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®…
Biocon/Yoshindo Launch Subcutaneous Biosimilar Ustekinumab in Japan
On 21 May 2025, Biocon Biologics announced that Yoshindo, its commercial partner, has launched Ustekinumab BS Subcutaneous Injection in Japan for treatment of psoriasis vulgaris and psoriatic…
US Jury Awards Regeneron Over US$400M in Damages: Amgen Prevented Competition Between PCSK9 Inhibitors
On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic…
Sandoz Launches First Biosimilar Ustekinumab Autoinjector in Europe
On 21 May 2025, Sandoz announced the launch of its Pyzchiva® autoinjector as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. The autoinjector is currently…
Alexion Fails in UK Infringement Actions Against Samsung Bioepis’ & Amgen’s Eculizumab Biosimilars
On 21 May 2025, Mr Justice Meade of the High Court of Justice for England and Wales delivered his decision in proceedings involving allegations of patent infringement by Alexion against each of Samsung Bioepis and Amgen…
US FDA Votes in Favour of Darzalex Faspro® Benefit-Risk Profile
On 20 May 2025, Johnson & Johnson (J&J) announced that the US FDA has voted (6-2) in favour of the benefit-risk profile of single-agent Darzalex Faspro® (daratumumab and hyaluronidase-fihj) for…
Formycon/Fresenius Secure US Interchangeability for Biosimilar Ustekinumab
On 19 May 2025, Formycon and Fresenius Kabi announced that the US FDA has designated FYB202/Otulfi® (ustekinumab-aauz) as interchangeable with J&J/Janssen’s Stelara® (ustekinumab) in…
New Indication Alert: BMS’ Opdivo® (Nivolumab) Combo Approved in Europe for NSCLC
On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by…