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On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for review by the FDA.  The Prescription Drug User Fee Act (PDUFA) target date is 29 July 2026.

If app...

On 15 June 2026, Celltrion announced that it has launched its rituximab and bevacizumab biosimilars in Vietnam.  Truxima®, biosimilar to Roche/Genentech/Biogen’s Rituxan®/MabThera® (rituximab), and Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) were launc...

On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with MSD’s Welireg® (belzutifan) for the adjuvant treatment of adults with renal cell carcinoma with a clear ...

On 12 June 2026, Amgen provided an update in relation to its phase 3 clinical trial for ABP 938 8 mg, biosimilar to Regeneron/Bayer’s Eylea HD® (aflibercept, 8 mg).

The clinical trial was commenced in May 2026 and aims to demonstrate similarity in efficacy between AB...

On 11 June 2026, Ono Pharma announced that it submitted a supplemental application for Opdivo® Intravenous Infusion (nivolumab) in Japan, to expand its use for the treatment of unresectable anaplastic thyroid cancer.

Ono first launched Opdivo® in Japan in September 2...

On 11 June 2026, Xbrane Biopharma and JOINN Biologics US announced that they have entered into a strategic partnership to develop Xbrane’s Xdarzane™, biosimilar to J&J’s Darzalex® (daratumumab).

Under the agreement, US-based Contract Development & Manufacturi...

On 10 June 2026, GxP News reported that Biocad has commenced patient enrolment for a phase 3 clinical trial of BCD-237 (trastuzumab emtansine), biosimilar to Genentech’s Kadcyla®, for treatment of locally advanced unresectable or metastatic HER2 positive breast cancer.

On 10 June 2026, Organon announced that the FDA has approved its supplemental Biologics License Application (sBLA) for Tofidence® (IV), biosimilar to Genentech’s Actemra® (tocilizumab), expanding the indications to include (a) treatment of patients 2 years and older with CA...