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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 ...

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®, biosimilar to Amgen’s Prolia®, and Fresenius Kabi’s Conexxence® and Bomyntra®, biosimi...

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 arthritis.

The launch follows the January 2025 approval of the subcutaneous...