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Henlius & Organon
NEWS

Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)

Shots: The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab In 2022,…
November 19, 2025

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Celltrion
NEWS

Celltrion Receives EC Approval for Remsima IV (Biosimilar, Remicade)  

Shots:  The EC has approved Remsima IV (100mg and 350mg vials), a liquid formulation, a biosimilar version of Remicade   The approval is supported by data showing the liquid and powder infliximab formulations are comparable in CMC characteristics and stability after reconstitution and dilution   The Remsima IV liquid formulation is EU-approved for all existing IV infliximab indications, including RA, adult and pediatric CD and UC,…
November 18, 2025

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Celltrion
NEWS

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

Shots: The EC has approved Omlyclo, a biosimilar version of Xolair (omalizumab), in PFS presentation (300 mg/2ml) for the treatment of pts with allergic asthma, chronic spontaneous urticaria (CSU) & chronic rhinosinusitis with nasal polyps (CRSwNP) Omlyclo previously received the EC approval in May 2024 for PFS injections at 75mg/0.5mL & 150mg/1mL Omalizumab is a…
November 18, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 2025)     

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:     Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025  Read More: Ionis  AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES) …
November 14, 2025

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NEWS

Gan & Lee Pharmaceuticals Gains the CHMP’s Positive Opinion for Ondibta (Biosimilar, Lantus SoloStar) 

Shots:  The CHMP has recommended Ondibta, a biosimilar insulin glargine pre-filled pen for pts (age≥ 2), reference medicine Lantus SoloStar. The EC will now review the opinion, and approval is anticipated across the EU and EEA states   Insulin glargine is a long-acting, once-daily basal insulin analog that provides up to 24 hours of steady, peakless glucose-lowering activity   Ondibta completed head-to-head P-III trials in both the EU and the US against Lantus, with studies in…
November 13, 2025

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NEWS

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…
November 12, 2025

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WEEKLY SNAPSHOT

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

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:     Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINYLung06) Trial of Enhertu + Keytruda to Treat HER2 Overexpressing Non-Squamous NSCLC  Read More: Daiichi Sankyo  Genentech Reports P-III (ALLEGORY) Trial…
November 7, 2025

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NEWS

Alvotech & Advanz Pharma’s Gobivaz (Biosimilar, Simponi) Receives the MHRA’s Approval to Treat Several Chronic Inflammatory Diseases

Shots: The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…
November 7, 2025

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NEWS

Samsung Bioepis & Johnson & Johnson have Entered into an Agreement for the Commercialization of Pyzchiva (Biosimilar, Stelara) Across EU 

Shots:  Samsung Bioepis has signed a confidential settlement and license agreement with Johnson & Johnson for the commercialization of Pyzchiva, its Stelara (ustekinumab) biosimilar in Europe  Ustekinumab is an IgG1κ monoclonal antibody targeting IL-12 and IL-23. PYZCHIVA, developed by Samsung Bioepis, received European Commission approval as a Stelara biosimilar in April 2024  PYZCHIVA was introduced in the EU by Sandoz in July…
November 6, 2025

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