On June 19, 2026, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA Complaint in the U.S. District Court for the Eastern District of Virginia against Alvotech hf. and Alvotech USA Inc. (collectively, “Alvotech”) for patent
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Xbrane Biopharma AB and JOINN Biologics US Inc. Partner to Develop Xdarzane
On June 12, 2026, Xbrane Biopharma AB (“Xbrane”) and JOINN Biologics US Inc. (“JOINN”) announced a strategic partnership to develop Xdarzane, Xbrane’s biosimilar candidate to DARZALEX (daratumumab), which is approved for the treatment of multiple myeloma. Big Molecule Watch has
FDA Expands TOFIDENCE® (tocilizumab-bavi) Label to Include CRS and COVID-19
On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi), an intravenous biosimilar to Genentech’s ACTEMRA® (tocilizumab). The approval expands TOFIDENCE’s indications to include: (1)
Teva Launches AHZANTIVE® Aflibercept Biosimilar in Europe
On June 4, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced the launch of its aflibercept biosimilar, AHZANTIVE®, in Europe. According to Teva’s press release, the launch of AHZANTIVE® pre-filled syringes across European markets commenced in May 2026. The launch follows
Client Alert on the SEC’s Proposed Elimination of “Baby Shelf” Limitations
We recently published a client alert on the SEC’s proposal to eliminate the longstanding “baby shelf” limitations and significantly expand access to Form S-3 and shelf registration for public companies. While the proposal remains subject to public comment and final
Incyte to Acquire Vega Therapeutics, Adding Phase 3 Bleeding Disorder Asset
On June 8, Incyte announced that it has entered into a definitive agreement to acquire Vega Therapeutics, a wholly owned subsidiary of Star Therapeutics. The transaction would add VGA039, an investigational monoclonal antibody in Phase 3 development for von Willebrand
FDA Approves Lupin’s Ranibizumab Biosimilar
On June 5, Lupin announced that the U.S. Food and Drug Administration (“FDA”) approved RANLUSPEC, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC, which received European Marketing Authorization earlier this year, is indicated for the treatment of neovascular (wet) age-related
Alvotech’s BLA for Vedolizumab Biosimilar First to be Accepted by FDA
On June 8, Alvotech announced that the U.S. Food and Drug Administration (“FDA”) has accepted Alvotech’s Biologics License Application (“BLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s ENTYVIO (vedolizumab), for review. ENTYVIO is a humanized monoclonal antibody approved for
Chime Biologics and Daewoong Pharmaceutical Partner on Dupilumab Biosimilar
On June 2, 2026, Chime Biologics and Daewoong Pharmaceutical announced a strategic partnership agreement for the development and manufacturing of a dupilumab biosimilar candidate referencing Sanofi and Regeneron’s DUPIXENT.
Chime Biologics is a global CDMO headquartered in China and with
BIOSECURE Update – 1260H List Released
The Department of Defense has published its updated Section 1260H list of “Chinese military companies” this week, and WuXi AppTec along with 27 other new entities were identified on the list. (Federal Register notice available here: https://public-inspection.federalregister.gov/2026-11571.pdf.) DoD