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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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Viewpoint_Ted_Omachi_2021
VIEWPOINTS

PharmaShots Interview: Genentech’s Ted Omachi Shares Insight on the US FDA’s Approval of Xolair in Nasal polyps

In a recent interview with PharmaShots, Ted Omachi, Global Development Leader for Xolair, and Senior Medical Director of Product Development for Immunology, Genentech shared his views on the approval of Xolair in the US. Shots: The approval is based on P-III POLYP 1 & 2 trials assessing Xolair vs PBO in 138 & 127 adult patients with…
January 6, 2021

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Viewpoint_Ted Omachi_2020
VIEWPOINTS

PharmaShots Interview: Genentech’s Ted Omachi Shares Insights on Xolair (omalizumab) PFS

The US FDA has accepted the sBLA for a new self-administration option for Xolair (omalizumab) across all approved US indications. In an interview with PharmaShots, Ted Omachi the Global Development Leader for Xolair and Senior Medical Director of Product Development Immunology shares details and highlights of Xolair (omalizumab) PFS for self-administration. Shots: A decision on…
September 7, 2020

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Insights+ Key Biosimilars Events of May 2019
INSIGHTS+

Insights+ Key Biosimilars Events of May 2019

Biosimilars are going in market with vast emerging needs of people for multiple diseases. The biologics that are too costly to be used in the markets. Hence physicians are developing biosimilars a reference product to biologics which are biologically similar to biologics. Our team at PharmaShots have summarized some of the news regarding biosimilars in…
June 4, 2019

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