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Celltrion announced in a corporate filing that its phase III clinical trial demonstrated that CT-P17, biosimilar to AbbVie’s Humira® (adalimumab), is interchangeable with Humira® in patients with plaque psoriasis.  Celltrion plans to apply to the FDA for interchangeability ...

Nikkei Asia reported that Eisai will apply to the FDA to expand the approval Leqembi® (lecanemab) to use for prevention of Alzheimer’s disease (AD) as soon as April 2026.  Clinical trials are in the final stages.  Leqembi® was co-developed by Eisai and Biogen.

Leqemb...

Biocon Biologics announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan.

Biocon Biologics acquired the glob...

Daiichi Sankyo and MSD announced that the FDA has accepted for priority review its Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously...

Johnson & Johnson announced it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of Rybrevant® (amivantamab) combined with lazertinib, as a first-line treatment of adult patients with advanced non-small cell lu...

The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent.  The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings IPR2023-01069 and ...

The Business Standard reported that AstraZeneca Pharma India said it will launch Enhertu® (trastuzumab deruxtecan) to treat HER2-positive breast cancer in India in January 2024.