Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)

Shots: The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total…

ByRidhi RastogiMarch 28, 2025

News

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

News

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

Shots: The UK’s MHRA has accepted MAA of AVT23, a proposed biosimilar of Xolair (omalizumab) for the treatment of severe persistent allergic asthma & CRSwNP Alvotech & Advanz Pharma entered into a commercialization agreement for AVT23 in Feb 2023, expanding their alliance in May to incl. 5 more biosimilars, whereas in Oct 2023, Alvotech &…

ByRidhi RastogiMarch 26, 2025

News

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Shots: Celltrion has launched SteQeyma (ustekinumab-stba) injection, a biosimilar to Stelara, for all indications of the reference products following the US FDA’s approval in Dec 2024 Approval was supported by various clinical evidence incl. P-III trial of SteQeyma vs Stelara for mod. to sev. plaque PsO, with 1EP as rate of change in the PASI for skin…

ByRidhi RastogiMarch 17, 2025

VIEWPOINTS

Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

Shots: At the American Academy of Ophthalmology (AAO 2024), Biocon Biologics announced promising results from the extension study of its proposed biosimilar to aflibercept, MYL-1701P The study demonstrated comparable safety, efficacy, and immunogenicity between patients continuing MYL-1701P and those who switched from aflibercept to MYL-1701P Biocon Biologics' Chief Medical Officer, Uwe Gudat, discusses the groundbreaking…

BySaurabh ChaubeyMarch 17, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)  

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars & Animal Health. Check out our full report below:  Incyte Highlights P-III (TRuE-PN) Clinical Program Data of Opzelura (1.5% Ruxolitinib Cream) for Prurigo Nodularis (PN) at AAD 2025 Read More: Incyte Johnson & Johnson Highlights P-III Clinical Data of Icotrokinra for Plaque Psoriasis at…

BySenior EditorMarch 13, 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…

ByRidhi RastogiMarch 10, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025) 

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: GSK Presents Pooled Analysis from P-III (ANCHOR-1 & 2) Trial of Depemokimab for CRSwNP at AAAAI/WAO Joint Congress 2025 Read More: GSK Daiichi Sankyo Reports Interim Data of P-III (DESTINY-Gastric04) Study…

BySenior EditorMarch 7, 2025

News

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The US FDA has approved Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products Approval is based on P-III trial results in postmenopausal women with osteoporosis, which showed equivalent efficacy & PD of CT-P41 to reference denosumab, with similar PK and comparable safety, and…

ByRidhi RastogiMarch 5, 2025

Weekly Snapshot

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & DigiHealth. Check out our full report below: Estrella Immunopharma Reports the Approval to Start a Higher Dose Cohort After the Completion of First Dose Cohort in STARLIGHT-1 Study Read More: Estrella Immunopharma Regeneron Presents P-I/II (CHORD) Trial Data…

BySenior EditorFebruary 28, 2025

Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)

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

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

Celltrion launches SteQeyma (Biosimilar, Stelara) in the US

Biocon Biologics at AAO 2024: Uwe Gudat in an Invigorating Discussion with PharmaShots

PharmaShots Weekly Snapshots (March 10, 2025 – March 13, 2025)

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

PharmaShots Weekly Snapshots (March 03, 2025 – March 07, 2025)

Celltrion Reports the US FDA approval for Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

PharmaShots Weekly Snapshots (February 24, 2025 – February 28, 2025)

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