As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab). On October 16, 2025, Xbrane Biopharma AB announced that it has entered into a financing solution with Fenja Capital II A/S (Fenja) to proactively secure the…
On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular subdomain IV at a different binding site than trastuzumab, another anti-HER2 antibody. According to Henlius, “[i]n addition…
On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). Under the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the…
On September 13, 2024, Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar of EYLEA®. According to Alteogen, a 12-country Phase 3 study showed that ALT-L9 met its primary endpoint and demonstrated therapeutic equivalence to EYLEA®. On July 1, 2024, Alteogen’s subsidiary, Altos…
On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). According to Sandoz, the FDA also “provisionally determined that ENVEEZUTM would be interchangeable with…
On July 8, 2024, Outlook Therapeutics announced it received marketing authorization from UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of wet AMD in the UK. As we previously reported, Outlook Therapeutics received marketing authorization for LYTENAVA™ in the EU on May 28, 2024. With these approvals,…
On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab). BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous use in a single-dose vial as interchangeable with SOLIRIS. The product is approved for the treatment…
On April 22, 2024, the PTAB issued final written decisions in IPR2023-00070 and IPR2023-00074, filed by Bluebird Bio on two patents related to recombinant lentiviral vectors — U.S. Patent Nos. 7,541,179 and 8,058,061, owned by Sloan Kettering Institute for Cancer Research. The PTAB ruled that all challenged claims of the…
On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD). MLD is a rare, fatal genetic disease affecting approximately one in every 40,000 individuals in the U.S. LENMELDY is made from patient’s own hematopoietic (blood) stem…
On February 16, 2024, the FDA approved Iovance’s AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma. AMTAGVI is indicated to treat adult patients with unresectable or metastatic melanoma that have previously been treated with a PD-1 blocking antibody, and if BRAF…