Top 5 Most-Read Oncology Articles of 2024

The top 5 oncology biosimilar articles in 2024 include key developments such as Duke's recommendations for cell and gene therapy (CGT) biosimilars, FDA approval of Shanghai Henlius Biotech's trastuzumab biosimilar, and a business recap featuring layoffs at Boehringer Ingelheim and a new partnership between Teva and mAbxience. Other highlights are the safety of rituximab biosimilar CT-P10 for patients with systemic lupus erythematosus (SLE) and the FDA approval of Coherus' biosimilar to Neulasta Onpro.

Here are the top 5 oncology biosimilar articles in 2024.

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5. Duke Publishes Recommendations for Developing CGT Biosimilars

The Duke Margolis Institute for Health Policy has published recommendations to foster a competitive market for biosimilar CGTs to reduce high treatment costs. The report highlights the need for regulatory adjustments, including guidance on biosimilarity, enhanced manufacturing standardization, and improved patent transparency to facilitate biosimilar development. It also calls for collaboration among stakeholders to address regulatory gaps and improve accessibility to CGT biosimilars once innovator patents expire.

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4. FDA Approves Henlius’ Trastuzumab Biosimilar, Hercessi

The FDA has approved Shanghai Henlius Biotech’s trastuzumab biosimilar, Hercessi (trastuzumab-strf; HLX02), for the treatment of HER2-positive breast cancer, marking the company’s first biosimilar approval in the US. Accord BioPharma will handle the regulatory approval, commercialization, and development of HLX02 in the US and Canada. HLX02, already approved in over 40 countries, offers a cost-effective alternative to Herceptin (reference trastuzumab) and aims to improve access to treatment for patients with HER2-positive breast cancer.

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3. Biosimilar Business Recap: BI Layoffs; Teva, mAbxience Partnership; Phase 3 Keytruda Biosimilar Trial

Boehringer Ingelheim (BI) announced layoffs for sales staff working on its adalimumab biosimilar Cyltezo due to poor sales and payer reluctance, highlighting challenges in the biosimilar market. Meanwhile, Teva Pharmaceuticals and mAbxience formed a partnership to develop an oncology biosimilar, and Samsung Bioepis launched a phase 3 trial for its pembrolizumab biosimilar, SB27, targeting metastatic non-small cell lung cancer. These developments reflect ongoing efforts to expand biosimilar availability while addressing market and regulatory challenges.

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2. Biosimilar Rituximab Safe, Effective for SLE After Switching

A study found that switching from originator rituximab to biosimilar CT-P10 was both safe and effective in patients with SLE. The study demonstrated a significant reduction in disease activity after switching, as measured by the Systemic Lupus Erythematosus Disease Activity Index 2000 score, though adverse events were more frequent with the biosimilar, particularly pneumonia. However, the study's limitations include a small sample size, lack of a control group, and a shorter follow-up duration after switching.

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1. FDA Approves First Biosimilar for Neulasta Onpro

Coherus Biosciences has received FDA approval for its on-body injector version of Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta Onpro (reference pegfilgrastim with on-body injector). The device features a 5-minute injection time and an innovative retractable needle mechanism, designed to improve patient experience and enhance convenience for cancer patients. This approval follows the earlier FDA approval of Udenyca's autoinjector and comes after a previous complete response letter in 2023 that did not concern the product's safety or efficacy.

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