Shots:Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in FranceBioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in PolandRanibizumab is a recombinant humanized…
Shots:The US FDA has approved Gazyva (4 initial dose then Q6M) for the treatment of adults with lupus nephritis who are on SoC & also allowing a shorter 90min. infusion after the first dose for eligible ptsApproval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved…
Shots:The US FDA has approved Yuflyma, a biosimilar version of Humira (adalimumab) & its unbranded version for the treatment of HS in adolescents (≥12yrs.), & uveitis in children (≥2yrs.)Yuflyma, an anti-TNFα mAb, was previously approved by the FDA for rheumatoid & psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, &…
Shots:The CVMP has recommended Lenivia for the reduction of pain associated with osteoarthritis in dogs, with EC’s decision expected in Q4’25. Also, a commercial launch in the EU is planned for 2026Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs…
Shots:Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for CanadaThe agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturingBAT2506 is an IgG1 monoclonal antibody that targets…
Shots:The EMA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab), following the MHRA’s MAA acceptance earlier this yearAVT23 was jointly developed by Alvotech & Kashiv BioSciences, with Advanz Pharma obtaining commercial rights to AVT23 in the EEA, UK, Switzerland, Canada, Australia and New ZealandOmalizumab is a humanized mAb that…
Shots:Celltrion has launched Avtozma IV, a biosimilar to Actemra (tocilizumab) for all the approved indications of the reference product in the USIn Jan 2025, the FDA approved Avtozma based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional July 2025 FDA approval for…
Shots:Amgen has reported the global P-III (VESALIUS-CV) trial findings assessing Repatha vs PBO, both in addition to optimized lipid-lowering therapy in adults (n >12,000) at high CV risk without prior heart attack or strokeAt an mFU of 4.5yrs., the trial met its co-1EPs of time to first occurrence of composite of coronary heart…
Shots:The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…
Shots:The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciencesAdditionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approvalXolair is…

