EMA Marketing Authorization of New Drugs in February 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 5 Biologics and 2 New Chemical Entities in February 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Welireg to treat Von Hippel-Lindau & Renal Cell Carcinoma PharmaShots has compiled a list of 6 drugs…

ByDipanshu DixitMarch 18, 2025

NEWS

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)

Shots: The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …

ByDipanshu DixitMarch 18, 2025

INSIGHTS+

The US FDA New Drug Approvals in February 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of February 2025 The US FDA has approved a total of 3 new drug including 3 new molecular entities and leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Abbvie’s Emblaveo securing approval for…

ByDipanshu DixitMarch 11, 2025

NEWS

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Shots:The US FDA has approved & granted interchangeability designation to Omlyclo, a biosimilar to Xolair (omalizumab) for the treatment of mod. to sev. persistent asthma, CRSwNP, IgE-mediated food allergy, & chronic spontaneous urticaria (CSU) Approval was based on multiple clinical evidence, incl. P-III trial assessing Omlyclo (150mg, Q4W) vs Xolair (300mg, Q4W) in…

ByDipanshu DixitMarch 10, 2025

NEWS

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

Shots: Biocon Biologics revealed positive results from the P-III study demonstrating that Yesintek achieved equivalent efficacy, safety, immunogenicity, and PK vs reference product to treat mod. to sev. chronic plaque psoriasis (PsO) pts. (n=384, age= 18-80yrs.); data was presented at AAD 2025 The primary efficacy endpoint, percentage change in PASI scores at Wk. 12 showed…

ByDipanshu DixitMarch 7, 2025

INSIGHTS+

A Complete Account of EMA Approvals in 2024

Shots: In 2024, EMA approved around 53 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, vaccines, diagnostic agents, pneumology, nephrology, hepatology, ophthalmology, and endocrinology PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…

ByDipanshu DixitMarch 6, 2025

INSIGHTS+

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

Dipanshu Dixit

EMA Marketing Authorization of New Drugs in February 2025

Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)

The US FDA New Drug Approvals in February 2025

Celltrion’s Omlyclo (Biosimilar, Xolair) Secures the US FDA’s Approval

Biocon Biologics Report the P-III Study Positive Results of Yesintek (Biosimilar, Stelara)

A Complete Account of EMA Approvals in 2024

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

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