Respiratory

FDA Draft Guidance Removes Switching Study Requirements for Biosimilar Interchangeability

June 20th 2024

By Skylar Jeremias

Article

The 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: Application Acceptances, European Approvals, New Partnerships

June 6th 2024

By Skylar Jeremias

Article

American and European regulatory agencies have provided companies with good news, with several biosimilar candidates seeing application acceptances or approvals in Europe.

Eye on Pharma: Biosimilar Ozempic; Celltrion Omalizumab Biosimilar Submission

April 4th 2024

By Skylar Jeremias

Article

A Chinese company has expressed interest in developing a biosimilar to Ozempic (semaglutide); Celltrion completed its biologic license application for its omalizumab biosimilar candidate.

Biosimilars Check-In: BI Launches Unbranded Adalimumab; New Omalizumab Deal; CRL for Insulin Aspart

October 10th 2023

By Skylar Jeremias

Article

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.

Eye on Pharma: Omalizumab Results; Korean Insulin Launch; Quebec to Cover Byooviz

July 12th 2023

By Skylar Jeremias

Article

Kashiv 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.

Celltrion Confirms Biosimilarity of Xolair Biosimilar

April 10th 2023

By Skylar Jeremias

Article

Celltrion Healthcare shared data from a phase 3 clinical trial confirming that its omalizumab biosimilar had comparable safety and efficacy to the reference product (Xolair).

Preclinical Study Shows Comparability Between Omalizumab Biosimilar, Xolair

February 11th 2023

By Deana Ferreri, PhD

Article

The 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 2022

By Skylar Jeremias

Article

A 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.

Biosimilar Business News Roundup: Russia Launches Omalizumab; Remsima Sales Soar; Xbrane Trial Results

February 16th 2022

By Skylar Jeremias

Article

Selexis and Generium launched an omalizumab biosimilar on the Russian market; Remsima sales hit a record high for Celltrion Healthcare; Xbrane Biopharma shares long-term results for its ranibizumab biosimilar.

Alvotech Enters Licensing Agreement With BiosanaPharma for Development of Biosimilar for Xolair

February 2nd 2022

By The Center for Biosimilars

Article

Xolair, 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.