April 14th 2025
During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
November 27th 2024
FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability
June 20th 2024The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.
Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart
October 10th 2023Boehringer 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.
Eye on Pharma: Omalizumab Results; Korean Insulin Launch; Quebec to Cover Byooviz
July 12th 2023Kashiv Biosciences announced positive phase 1 results for its omalizumab biosimilar; Dongkook Pharmaceutical shared the launch of an insulin glargine biosimilar (Glargia); and Quebec, a province in Canada, said it’s adding a ranibizumab biosimilar (Byooviz) to its reimbursement list.
Preclinical Study Shows Comparability Between Omalizumab Biosimilar, Xolair
February 11th 2023The proposed omalizumab biosimilar KA (Shanghai Taiyin Biotechnology) demonstrated similar analytical characteristics, in vitro biological activity, and pharmacology and toxicology in animals compared with the originator (Xolair), according to investigators.
Celltrion Biosimilar Demonstrates Equivalence With Xolair in Phase 1 Study
March 14th 2022A phase 1 study testing Celltrion Healthcare’s omalizumab biosimilar in healthy subjects showed similar safety and pharmacokinetic profiles to the reference product (Xolair), as presented at the American Academy of Allergy Asthma and Immunology’s annual meeting.
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.