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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.

mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more than 150 countries including Europe and the US for various autoimmune disorders.  mAb...

A Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated that SB15, its biosimilar to Regeneron’s Eylea® (aflibercept), had comparable efficacy, safety, pharmacokinetics and immunogenicity to Eylea® up to week 56 in patients with neovascular age- related mac...

A study published in Reumatismo found that Samsung Bioepis’ SB4, biosimilar to Amgen’s Enbrel® (etanercept), and Amgen’s ABP501, biosimilar to AbbVie’s Humira® (adalimumab) both have similar safety profiles to their respective originator products in patients with rheumatoid...