Oncology

Eye on Pharma: EU Approves High-Concentration Adalimumab Biosimilar; FDA Accepts BLA for HLX02

April 6th 2023

By Skylar Jeremias

The European Union gained another high-concentration adalimumab biosimilar with the approval of Sandoz’ Hyrimoz HCF and the FDA accepted a biologics license application for a trastuzumab biosimilar (HLX02).

Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin

March 9th 2023

By Skylar Jeremias

Article

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

FDA Approves Autoinjector Version of Neulasta Biosimilar

March 6th 2023

By Skylar Jeremias

Article

The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.

Review: 15 Years of Real-world Data Demonstrates Safety of Epoetin Alfa Biosimilar HX575

March 4th 2023

By Deana Ferreri, PhD

Article

Authors of a review of safety results across indications and study designs on the epoetin alfa biosimilar HX575 concluded that HX575 “has repeatedly demonstrated long-term safety” in all approved indications in both clinical trials and real-world studies.

Sintilimab Plus Bevacizumab Biosimilar Therapy Associated With Better Outcomes, Higher Costs Than Lenvatinib

February 25th 2023

By Deana Ferreri, PhD

Article

According to the authors of a cost-effectiveness analysis of treatments for hepatocellular carcinoma (HCC) in China, sintilimab plus a bevacizumab biosimilar could improve quality of life for patients, but at a higher cost than lenvatinib.

Biosimilar Business Recap: New Ustekinumab Partnership; Similis Bio Biosimilar Programs; Celltrion Japan Launch

February 23rd 2023

By Skylar Jeremias

Article

Fresenius Kabi announced a global partnership with Formycon for an ustekinumab biosimilar; Similis Bio partners with Novel351K to co-develop 3 biosimilars; and Celltrion Healthcare launched its bevacizumab biosimilar in Japan.

Fresenius Kabi Launches Stimufend in the US

February 16th 2023

By Skylar Jeremias

Article

Fresenius Kabi announced the US launch of its pegfilgrastim biosimilar Stimufend (pegfilgrastim-fpgk), making it the fifth biosimilar referencing Neulasta to enter the market.

FDA Issues CRL for Biocon Biologics, Viatris Avastin Biosimilar

February 14th 2023

By Skylar Jeremias

Article

Biocon Biologics and its partner Viatris received a complete response letter (CRL) for their biosimilar referencing Avastin (bevacizumab), the second CRL for the companies in 2023. The news comes as Biocon publishes increased revenues for biosimilars and generics.

Eye on Pharma: Formycon Aflibercept Data; Sandoz CHMP Nod; Henlius Daratumumab Study

February 8th 2023

By Skylar Jeremias

Article

Formycon shared positive data on its Eylea (aflibercept) biosimilar; Sandoz received a thumbs up from the European Union’s Committee for Medicinal Products for Human Use (CHMP); and Shanghai Henlius Biotech began a phase 1 study for its daratumumab biosimilar candidate.

Biosimilars Check-in: Approval in Saudi Arabia, Launch in Republic of Korea, Dr. Reddy’s Completes Study

January 26th 2023

By Skylar Jeremias

Article

Saudi Arabia approved an adalimumab biosimilar, a denosumab biosimilar entered the market in the Republic of Korea, and Dr. Reddy’s Laboratories announced the completion of a phase 3 study for its rituximab biosimilar.