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Amneal Pharmaceuticals Reports the US FDA’s BLA Filing for Biosimilar Candidate to Xolair (Omalizumab)

Shots: The US FDA has received a BLA for a biosimilar candidate to Novartis’ Xolair (omalizumab), developed by Kashiv BioSciences Additionally, Amneal expects to incur a $22.5M R&D milestone charge in Q3’25 instead of Q4 due to the earlier BLA filing & holds exclusive US commercialization rights for the product pending regulatory approval Xolair is…
September 29, 2025

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TOP 20

Top 20 Monoclonal Antibodies of 2025 

Shots:  Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas  As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…
September 18, 2025

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NEWS

Kashiv BioSciences Collaborates with CRISTÁLIA to Commercialize ADL-018 (Biosimilar, Xolair) in Latin America

Shots: Kashiv BioSciences has entered into a licensing & supply agreement with CRISTÁLIA for the commercialization of ADL-018, a biosimilar version of Xolair (omalizumab) in Latin America As per the deal, CRISTÁLIA will handle licensing, distribution, & commercialization of ADL-018 in the LATAM region, while Kashiv BioSciences will be responsible for the development within the agreed…
September 12, 2025

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Top 20 immunology companies of 2025
TOP 20

Top 20 Immunology Companies of 2025

Shots:  Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes  In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…
July 24, 2025

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NEWS

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…
June 27, 2025

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Alvotech, Kashiv Biosciences & Advanz Pharma
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 &…
March 26, 2025

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Celltrion
NEWS

Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair) 

Shots:  The Health Canada has granted approval to Celltrion’s Omlyclo, a biosimilar version of Xolair (omalizumab)  The approval was based on clinical outcomes incl. P-III trial assessing the safety, efficacy & PK/PD of Omlyclo vs Xolair in patients with chronic idiopathic urticaria (CIU) for over 40wks., depicting therapeutic equivalence b/w the drugs  Omlyclo (75mg/0.5mL &…
December 9, 2024

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Celltrion
NEWS

The EC Grants Approval to Celltrion’s Omlyclo (Biosimilar, Xolair)

Shots:  Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)  The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…
May 23, 2024

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