October 10th 2023
Boehringer Ingelheim (BI) launches an unbranded version of its adalimumab biosimilar; Alvotech and Kashiv Biosciences partner for an omalizumab biosimilar candidate; the FDA issues a complete response letter (CRL) for Biocon’s insulin aspart biosimilar.
An Article in the American Journal of Managed Care’s Evidence-Based Oncology: Navigating the Complexities of Frontline Immunotherapy in NSCLC
2 Credits / Oncology, Pulmonology/Respiratory
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Uncovering the Economic Burden of Chronic Cough and the Promising Role of Emerging Targeted Therapies
3.0 Credits / Pulmonology/Respiratory
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Perspectives on Emerging Data for the Use of Immunotherapy in the Treatment of Early-Stage Non-Small Cell Lung Cancer
1.5 Credits / Oncology, Pulmonology/Respiratory
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Evolving Treatment Strategies in the Management of Pulmonary Arterial Hypertension: Key Insights for the Pharmacist, featuring a Patient Perspective
1.5 Credits / Pulmonology/Respiratory
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Advances in EGFR Exon 20 Insertion-Positive Non–Small Cell Lung Cancer: A Focus on Specialty Pharmacy Interventions
1.5 Credits / Oncology, Pulmonology/Respiratory
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Advances and Best Practices for Managed Care Pharmacists and the Treatment of Patients with Alpha-1 Antitrypsin Deficiency
1.0 Credit / Pulmonology/Respiratory
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Alvotech Enters Licensing Agreement With BiosanaPharma for Development of Biosimilar for Xolair
February 2nd 2022Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Current sales of Xolair are estimated at $3.3 billion.
Celltrion to Start Phase 1 Trial of Omalizumab Biosimilar, CT-P39
July 16th 2019Republic of Korea–based drug maker Celltrion announced this week that it is launching its first clinical trial of CT-P39, a proposed biosimilar omalizumab referencing Xolair. The company says that it plans to enter phase 3 trials in the first half of 2020 and has plans to commercialize the biosimilar by 2022.
BiosanaPharma to Start Phase 1 Trial of Biosimilar Omalizumab in Australia
April 5th 2019Biosana Pty Ltd, a subsidiary of BiosanaPharma BV, says it received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase 1 trial for a biosimilar version of omalizumab.
Novartis Prepares to Defend Omalizumab Market as Potential Biosimilars Advance
December 10th 2018In October, the FDA granted approval for a pre-filled syringe formulation of the reference product. Additionally, Novartis is looking to expand omalizumab’s indications, as it recently earned FDA’s breakthrough therapy designation in August 2018 as a treatment for food allergies.
Eye on Pharma: Positive Phase 1 Data for Glenmark's Omalizumab Biosimilar
July 26th 2018A little over a year after having received FDA authorization to commence its clinical program, Glenmark Pharmaceuticals has announced that its phase 1 study of GBR 310 revealed similar pharmacokinetic, pharmacodynamic, safety, and immunogenicity profiles between its proposed omalizumab biosimilar and the reference product, Xolair.