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On 29 June 2026, Samsung Bioepis announced positive results from global Phase 1 and Phase 3 clinical trials, confirming equivalence of SB27 (pembrolizumab) with the reference product, MSD’s Keytruda®.  According to Samsung Bioepis, it is the first developer of a pembrolizum...

On 26 June 2026, Replimune announced that its third submission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma has been accepted for review by the FDA.  A targ...

On 26 June 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its June 2026 meeting, including positive opinions for two biosimilars and recommended indication extensions for a number of biopharmaceuticals.<...

On 25 June 2026, MSD announced that the FDA has approved each of Keytruda® (pembrolizumab) and Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Gilead’s Trodelvy® (sacituzumab govitecan-hziy) for the first-line treatment of adults with unr...

On 23 June 2026, Organon and Shanghai Henlius announced the Canadian launch of Bildyos® (denosumab injection, 60 mg/1 mL) and Tuzemty® (denosumab injection, 120 mg/1.7 mL), indicated for all approved reference indications of Amgen’s Prolia® and Xgeva®, respectively.

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On 22 June 2026, AbbVie and Apogee Therapeutics announced that they have entered into a definitive agreement for the acquisition by AbbVie of all outstanding shares of Apogee Therapeutics in an all-cash transaction valued at approximately USD$10.9 billion ($135.11 per share...

On 19 June 2026, Janssen filed a BPCIA complaint against Alvotech in the US District Court for the Eastern District of Virginia alleging that Alvotech’s golimumab biosimilars, AVT05 SC and IV, infringe 14 Janssen patents relating to Simponi® (SC), Simponi Aria® (IV) and the...