The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…

ByRidhi RastogiMarch 27, 2025

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China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

Shots: China’s NMPA has accepted BLA of Tivdak for the treatment of recurrent or metastatic cervical cancer in pts who had disease progression on or after systemic therapy The BLA was supported by P-III (innovaTV 301) trial data, incl. clinical evidence from Chinese cohort, evaluating Tivdak vs CT in adults. Chinese pts had prior standard…

ByRidhi RastogiMarch 13, 2025

NEWS

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Shots: The FDA has accepted review application for BLA of depemokimab as an add-on maintenance therapy for inadequately controlled asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as CRSwNP (PDUFA: Dec 16, 2025), based on P-III (SWIFT & ANCHOR) trials, respectively SWIFT-1 (n=382) & SWIFT-2 (n=380) studies assessed…

ByRidhi RastogiMarch 4, 2025

NEWS

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg)…

ByRidhi RastogiFebruary 12, 2025

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LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Shots: The US FDA has accepted BLA for lerodalcibep (PCSK9 inhibitor) to lower LDL-C in high-risk or ASCVD pts, HeFH/HoFH pts (≥10 yrs), & primary hyperlipidemia (incl. heterozygous) pts, with no advisory committee meeting planned yet (PDUFA: Dec 12, 2025); EMA’s MAA filing expected in Q2’25 Application was backed by the development program of…

ByRidhi RastogiFebruary 11, 2025

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Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Shots: The US FDA received BLA, plus a request for a priority review of apitegromab to improve motor function in pts with SMA who are on SMN-targeted therapy. The EMA’s MAA to be filed in Q1’25 The BLA was supported by the P-III (SAPPHIRE) & P-II (TOPAZ) trial, where SAPPHIRE met its 1EP of…

ByDipanshu DixitJanuary 30, 2025

NEWS

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots: The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…

ByRidhi RastogiJanuary 28, 2025

NEWS

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Shots: Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024 The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…

ByDipanshu DixitDecember 31, 2024

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Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Shots: Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US,…

ByDipanshu DixitOctober 11, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

Shots: The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab) Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris …

ByDipanshu DixitJuly 22, 2024

The US FDA Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

The US FDA Accepts GSK’s Depemokimab Review Application for Asthma with Type 2 Inflammation and Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

LIB Therapeutics Reports the US FDA’s BLA Acceptance for Lerodalcibep to Reduce LDL-Cholesterol in Cardiovascular Patients

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate

Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara)

Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris)

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