Polpharma Biologics Launches Ranivisio PFS (Biosimilar, Lucentis) in the EU

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…

ByRidhi RastogiOctober 22, 2025

NEWS

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

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…

ByRidhi RastogiOctober 21, 2025

NEWS

FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients

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, &…

ByRidhi RastogiOctober 17, 2025

NEWS

Zoetis’ Lenivia (Izenivetmab) Receives the CVMP’s Recommendation for Osteoarthritis Pain Relief in Dogs

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…

ByRidhi RastogiOctober 13, 2025

NEWS

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

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…

ByRidhi RastogiOctober 10, 2025

NEWS

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

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…

ByRidhi RastogiOctober 6, 2025

NEWS

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

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…

ByRidhi RastogiOctober 6, 2025

NEWS

Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults

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…

ByRidhi RastogiOctober 3, 2025

NEWS

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

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…

ByRidhi RastogiSeptember 30, 2025

NEWS

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

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…

ByRidhi RastogiSeptember 29, 2025

Genentech Reports the US FDA’s Approval of Gazyva (Obinutuzumab) to Treat Lupus Nephritis

FDA Approves Celltrion’s Yuflyma (Biosimilar, Humira) and its Unbranded Version for Hidradenitis Suppurativa (HS) and Uveitis in Younger Patients

Zoetis’ Lenivia (Izenivetmab) Receives the CVMP’s Recommendation for Osteoarthritis Pain Relief in Dogs

Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

Alvotech and Advanz Pharma Report the EMA’s MAA Acceptance of AVT23 (Biosimilar, Xolair)

Celltrion Introduces Avtozma IV (Biosimilar, Actemra) in the US

Amgen Reports P-III (VESALIUS-CV) Trial Findings on Repatha (Evolocumab) to Reduce Cardiovascular Risk in Adults

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

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