Read our latest updates & insights

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 in Europe.  The products covered by the agreement are biosimilars to Nov...

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 subcutaneous injection presentations to treat adults with moderately to severely ...

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 Stelara® (ustekinumab).

The approval of Starjemza® follows six ustekinumab biosimi...

On 27 May 2025, Sandoz’s Afqlir® and Enzeevu®, biosimilars to Regeneron/Bayer’s Eylea® (aflibercept 2mg), were approved by Australia’s Therapeutic Goods Administration (TGA) across 4 products:

Afqlir® – 40 mg/mL solution for intravitreal injection pre-filled ...

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®, in high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentrati...

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 J&J/Janssen’s Stelara® (ustekinumab).  Yesintek® is indicated for treatment of adults and...

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 treatment in adult patients with unresectable locally advanced or metastatic non-small cell ...

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 to AstraZeneca, the recommendation recognises and responds to the unmet need for treatment of ad...

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 8mg, 114.3 mg/ml solution for injection) with expanded treatment intervals of up to 6 mon...

On 22 May 2025, GSK announced that the US FDA has approved Nucala® (mepolizumab) as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype.

The FDA accepted GSK’s application for the indication expansion in ...