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Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

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Recent BioBlast® Updates

UCB Launches High Dose Bimekizumab in the US

Jan 16, 2025

On 16 January 2025, UCB announced that it has launched in the US a high dose presentation of Bimzelx® (bimekizumab-bkzx) in a single-injection 2 mL prefilled syringe and autoinjector, each containing 320 mg of Bimzelx®.  This is in addition to the currently available...

New Indication Alert: J&J’s Amivantamab Combination Therapy Approved in Canada for NSCLC

Jan 16, 2025

On 16 January 2025, Johnson & Johnson (J&J) announced that Health Canada has approved its Rybrevant® (amivantamab for injection) in combination with standard of care chemotherapy (carboplatin and pemetrexed) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 19 deletions or Exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with osimertinib.

Formycon/Fresenius’ Biosimilar Ustekinumab Approved in UK and Canada

Jan 15, 2025

On 15 January 2025, Formycon and Fresenius Kabi announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved FYB202/Otulfi®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

MSD Planning 2025 SC Pembrolizumab Launch

Jan 14, 2025

At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, MSD announced that it is expecting to “file, have approval, and launch [its] subcutaneous pembrolizumab in 2025”.

US FDA Accepts Eisai/Biogen’s BLA for Leqembi® Subcutaneous Maintenance Dosing

Jan 14, 2025

On 13-14 January 2025, Eisai and Biogen announced that the US FDA has accepted Eisai’s Biologics Licence Application (BLA) for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of Alzheimer’s disease in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease.

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