ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Shots: The US FDA has approved ProVee System for the treatment of benign prostatic hyperplasia (BPH) Approval was backed by the ProVIDE study assessing ProVee in men, which met its 1 & 2EPs, showing significant & durable symptom relief as well as improved urinary flow through 12mos. compared to sham, with preserved sexual function &…

ByRidhi RastogiDecember 10, 2025

NEWS

Zoetis’ Portela (Relfovetmab) Receives the Health Canada Approval for Osteoarthritis Pain Relief in Cats

Shots: Health Canada has approved Portela for alleviating osteoarthritis pain in cats. The company plans to launch Portela commercially in Canada and the EU in 2026 In a nine-month European trial, Portela eased OA pain and was well tolerated, including in cats with IRIS stage 1–3 kidney disease. Approved in the EU Portela is a…

ByDipanshu DixitDecember 8, 2025

NEWS

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Shots: The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL In…

ByRidhi RastogiDecember 5, 2025

NEWS

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…

ByRidhi RastogiDecember 4, 2025

NEWS

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots: The US FDA has approved Omlyclo, an interchangeable biosimilar version of Xolair (omalizumab), in PFS presentation (300mg/2ml, SC) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps (CRSwNP), & IgE-mediated food allergy Omlyclo previously received the US FDA approval in Mar 2025 for PFS injections at…

ByRidhi RastogiDecember 3, 2025

INSIGHTS+

Key Biosimilars Events of November 2025

Shots: Regulatory momentum accelerates globally, with major approvals across the US, EU, UK, and Canada for biosimilars targeting high-value biologics such as Simponi, Stelara, Perjeta, Prolia/Xgeva, Remicade, Xolair, Eylea, Lucentis, and Lantus SoloStar, strengthening patient access in immunology, oncology, ophthalmology, diabetes, and allergy/asthma Sandoz, Alvotech, Celltrion, Henlius/Organon, Teva, and others expand portfolios and market reach, including multiple EC and…

ByDipanshu DixitDecember 2, 2025

NEWS

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.) Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed…

ByRidhi RastogiDecember 2, 2025

NEWS

Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Pecondle (picankibart) for the treatment of mod. to sev. plaque psoriasis (PsO) in adults who are candidates for systematic therapy Approval was supported by the P-III (CLEAR-1) trial in Chinese pts with mod. to sev. PsO, where picankibart demonstrated significantly higher PASI 90 (1EP; 80.3% vs 2%) & sPGA 0/1…

ByRidhi RastogiNovember 28, 2025

NEWS

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives Health Canada Approval to Treat Multiple Retinal Diseases

Shots: Health Canada has approved Eydenzelt, a biosimilar version of Eylea (aflibercept 2mg), in both vial & PFS presentation for all the indications of the reference product Approval was based on extensive analytical, nonclinical, & clinical data, incl. a global 52wk. P-III trial of Eydenzelt vs Eylea in 348 pts with diabetic macular edema, which met…

ByRidhi RastogiNovember 28, 2025

NEWS

Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

Shots: The EC has approved Lenivia (Q3W) for the reduction of pain associated with osteoarthritis in dogs Lenivia showed increased mobility & decreased pain after a single administration in a 9mos. field study, along with favorable safety in dogs Lenivia, a monoclonal antibody targeting NGF, is designed to provide longer-lasting pain relief in osteoarthritis by…

ByRidhi RastogiNovember 27, 2025

ProVerum Receives the US FDA Approval for ProVee System to Treat Benign Prostatic Hyperplasia

Zoetis’ Portela (Relfovetmab) Receives the Health Canada Approval for Osteoarthritis Pain Relief in Cats

BMS Reports the US FDA Approval of Breyanzi for R/R Marginal Zone Lymphoma (MZL)

Eli Lilly’s Jaypirca Receives the FDA Approval for R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

The US FDA Approves Additional Presentation of Celltrion’s Omlyclo (Biosimilar, Xolair)

Key Biosimilars Events of November 2025

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Celltrion’s Eydenzelt (Biosimilar, Eylea) Receives Health Canada Approval to Treat Multiple Retinal Diseases

Zoetis’ Lenivia (Izenivetmab) Receives the EC Approval for Osteoarthritis Pain Relief in Dogs

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