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The Top 5 Most-Read Oncology Stories of 2023
The top 5 most-read oncology stories of 2023 include the US market launch of Fylnetra, the sixth pegfilgrastim biosimilar on the market, the FDA approval for an autoinjector pegfilgrastim biosimilar, and more.
The top 5 most-read oncology stories of 2023 include the US market launch of Fylnetra, the sixth pegfilgrastim biosimilar on the market, the FDA approval for an autoinjector pegfilgrastim biosimilar, and more.
Here are the most-read oncology stories of 2023.
5. Fylnetra Launches in the United States
Amneal Pharmaceuticals launched its pegfilgrastim biosimilar, Fylnetra (pegfilgrastim-pbbk), in the United States, marking the sixth Neulasta biosimilar to enter the market. Fylnetra, designed for treating and preventing febrile neutropenia, is available in a prefilled single-dose syringe. Developed in collaboration with Kashiv Biosciences, the biosimilar received FDA approval in May 2022. Amneal, focusing on becoming a key player in the biosimilars market, considers Fylnetra's launch a step towards contributing to affordable medicines.
4. Samsung Bioepis Report Proves Lower Biosimilar Prices Correlate With Greater Market Share
The second Samsung Bioepis’ Biosimilar Market Report revealed a strong link between increased biosimilar market share and decreasing average sales prices (ASPs). Published as an update on US biosimilar trends, it noted the launch of biosimilars in pharmacy benefits, marking a new era in the US. The report quantified 41 FDA-approved and 37 launched biosimilars, with 10 entering the market in 2023. On average, biosimilars have gained a 53% market share within three years of launch, leading to a 41% decline in ASP. The report also detailed discounted wholesale acquisition costs in various therapeutic categories.
3. Biosimilars Business News Recap: A New Partnership; Celltrion Wins Tenders
Sandoz and Just-Evotec Biologics have partnered for a multiyear collaboration, allowing Sandoz to access Just-Evotec's drug substance development platform, expanding its biosimilar pipeline from 15 to 24 products. Celltrion Healthcare secured bids to supply its bevacizumab biosimilar (Vegzelma) in Belgium and three Italian provinces for treating metastatic colorectal and breast cancer. Alvotech initiated a confirmatory study for AVT05, its golimumab biosimilar, comparing safety, efficacy, and immunogenicity profiles with the reference product in patients with moderate to severe rheumatoid arthritis. The study is a randomized, double-blind, 2-arm, multicenter trial lasting 16 weeks.
2. Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin
The FDA accepted Shanghai Henlius Biotech and Accord BioPharma's biosimilar, HLX02, referencing Herceptin. HLX02 targets HER2-positive breast cancer and metastatic gastric cancer, marking China's first monoclonal antibody approved in China and the EU. The EMA accepted STADA Arzneimittel and Alvotech's ustekinumab biosimilar, AVT04, with a decision expected in H2 2023. Altos Biologics completed enrollment for a phase 3 trial of its aflibercept biosimilar for neovascular age-related macular degeneration. Minapharm Pharmaceuticals began a phase 1 trial in Germany for adalimumab biosimilar candidate, Adessia, targeting various chronic conditions.
1. FDA Approves Autoinjector Version of Neulasta Biosimilar
Coherus Biosciences gained FDA approval for an autoinjector version of its pegfilgrastim biosimilar, Udenyca, streamlining post-chemotherapy administration for febrile neutropenia prevention. The push-on-skin–triggered autoinjector provides immediate pegfilgrastim delivery, increasing convenience for patients. Coherus, dedicated to cancer treatment innovation, initially launched Udenyca in 2019. The autoinjector, emphasizing accessibility, benefits patients who find regular clinic visits challenging, noted Dr. Lee Schwartzberg.
