Key Biosimilars Events of February 2025

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   A major highlight was the Samsung Bioepis & Teva Partners to Commercialize…

ByDipanshu DixitMarch 4, 2025

NEWS

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The CHMP has recommended conditional approval of linvoseltamab for r/r MM pts who had ≥3 prior therapies (incl. proteasome inhibitor, immunomodulator, & anti-CD38 mAb) & had disease progression on last therapy, following the US FDA’s BLA acceptance (PDUFA: Jul 10, 2025) Opinion was based on P-I/II (LINKER-MM1) trial data assessing linvoseltamab (200mg; QW then…

ByDipanshu DixitMarch 3, 2025

NEWS

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Shots: Fresenius Kabi has launched Otulfi (ustekinumab- aauz) injection, a biosimilar to Stelara, developed by Formycon AG to treat mod. to sev. Crohn’s disease, ulcerative colitis, and plaque psoriasis & active psoriatic arthritis (age ≥ 6 yrs.) across the US Otulfi will be available in the US in 45 mg/0.5 mL and 90 mg/mL prefilled…

ByDipanshu DixitMarch 3, 2025

NEWS

Janssen’s Type II Variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) Receives CHMP’s Positive Opinion to Treat Multiple Myeloma

Shots: The positive opinion was granted by CHMP based on the results from the P-III (CARTITUDE-4) clinical trial evaluating the safety & efficacy of Carvykti vs Standard Therapy (Pomalidomide, Bortezomib & Dexamethasone (PVd)/Daratumumab, Pomalidomide and Dexamethasone (DPd)) in patients with r/lenalidomide-r multiple myeloma Patients in the trial have previously received 1-3 prior lines of therapy,…

ByDipanshu DixitFebruary 28, 2025

INSIGHTS+

Disease of the Month – Amyotrophic Lateral Sclerosis (ALS)

Shots: Amyotrophic lateral sclerosis (ALS) is a fatal motor neuron disease that leads to the progressive degeneration of nerve cells in the spinal cord and brain Our Disease of the Month report covers epidemiology, market size, current management strategies, emerging therapeutic options, and the role of patient advocacy groups. Additionally, we highlight the key industry…

ByDipanshu DixitFebruary 25, 2025

NEWS

BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

Shots: The positive opinion was supported by the P-III (COMMANDS) study assessing the safety & efficacy of Reblozyl (1.0mg/kg, titration ~1.75mg/kg, Q3W) vs epoetin alfa (450 IU/kg, titration ~1050IU/kg, QW) for ≥24 wks. to treat transfusion-dependent anemia due to very low-, low- or intermediate-risk (IPSS-R) MDS in patients naïve to erythropoiesis-stimulating agent The data, as…

ByDipanshu DixitFebruary 23, 2025

NEWS

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: Following the MHRA approval (Jan 2025), the EC has granted conditional MAA to Seladelpar +/- ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or intolerants to UDCA, respectively; ongoing regulatory review in Canada and Australia MAA was based on a worldwide P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs…

ByDipanshu DixitFebruary 21, 2025

NEWS

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots: The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…

ByDipanshu DixitFebruary 19, 2025

NEWS

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Shots: The UK’s MHRA & Swissmedic have approved Nemluvio (SC) for mod. to sev. PN & AD, where it is approved in adults for PN & in combination with TCS ± TCI in pts (≥12yrs.; ≥30kg) for AD who are candidates for systemic therapy. Awaits approval in Singapore & Australia Approval is based on P-III…

ByDipanshu DixitFebruary 18, 2025

NEWS

CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

Shots: The EC has approved Kostaive (ARCT-154) for active immunization to prevent COVID-19 in subjects of age ≥18yrs in the EU & EEA states following CHMP positive opinion in Dec 2024 Approval was based on Kostaive's clinical data incl. P-I/II/III showing its efficacy & tolerability, plus P-III COVID-19 booster trial depicting superior immunogenicity vs…

ByDipanshu DixitFebruary 18, 2025

Dipanshu Dixit

Key Biosimilars Events of February 2025

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Fresenius Kabi Launches Otulfi (Biosimilar, Stelara) in the US

Janssen’s Type II Variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) Receives CHMP’s Positive Opinion to Treat Multiple Myeloma

Disease of the Month – Amyotrophic Lateral Sclerosis (ALS)

BMS’ Reblozyl Gains CHMP’s Positive Opinion to Treat Transfusion-Dependent Anemia Due to Myelodysplastic Syndrome (MDS)

Gilead Receives EC’s Conditional Marketing for Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

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