Oncology

The approval of HLX03 marks the third biosimilar regulatory success in China for Henlius.

Investigators explained the potential for durable antitumor efficacy in patients with human epidermal growth factor receptor 2 (HER2)-expressing or -driven tumors who have exhausted other treatment options.

A high overall response rate of 93% was observed for patients with immune thrombocytopenic purpura who received romiplostim biosimilar.

A long-term, comparative, phase 3 trial of CT-P10 vs the rituximab originator product has provided evidence of biosimilar value in this blood disorder.

The wearable injector has a failure rate that adds hospitalization costs; therefore, biosimilar pegfilgrastim may hold cost advantages, investigators conclude.

The merger of Pfizer's Upjohn division and Mylan has created a biosimilars powerhouse with global reach.

A Shanghai Henlius Biotech study demonstrates equivalence for its bevacizumab candidate, and Celltrion moves forward with a trial for a SARS-CoV-2 candidate.

This marks the first time a Chinese company has filed application for marketing of a biosimilar outside of China. Bio-Thera of Guangzhou, China, said a US application is pending.

Joseph E. McClellan, PhD, MBA, discussed navigation of regulatory hurdles as the company continues its quest to line up distribution partnership deals across the globe.

Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.

GP2 peptide/G-CSF in HER2-equivocal and -positive breast cancer has shown promise.

Bevacizuamb biosimilar in combination with sintilimab delivered significantly improved overall survival vs sorafenib.

Pfizer aims to begin marketing Nyvepria in the European Union in the first quarter of 2021.

Their rituximab biosimilar candidate was advancing in clinical trials for equivalence but represented a business conflict.

Jorge Garcia, MS, assistant vice president of the System Oncology Pharmacy Service Line at Baptist Health South Florida, discussed how the pandemic has interrupted oncology care for patients and affected the utilization of pegfilgrastim biosimilars.

Despite a rocky power transition at the federal level, the compass heading for biosimilars is unchanged, said policy expert Molly Burich.

The International Generic and Biosimilar Medicines Association (IGBA) hopes to build momentum for the use of biosimilars.

Kathy Oubre, MS, chief operating officer at the Pontchartrain Cancer Center in Louisiana, discusses the value of biosimilars.

Alvotech and Cipla have joined forces to bring biosimilars to treat oncology and autoimmune diseases to South Africa.

Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.

Launched in the US market in late 2019, Truxima (rituximab) has become a significant revenue driver for Teva.

The company has multiple biosimilar products on the worldwide market and in development; in 2019, it gained World Health Organization precertification for a trastuzumab biosimilar (Ontruzant).

Manufacturers, not regulators, may be the holdouts when it comes to eliminating comparative clinical efficacy trials, according to experts interviewed by The Center for Biosimilars®.

This study of specialty drug spending looks beyond rebates to evaluate growth in spending from 2010 to 2017.

The FDA may require comparative clinical efficacy for biosimilar approval, but on top of all the other required and available evidence, these trials add little value, Sarfaraz K. Niazi, PhD, states.

The American College of Rheumatology (ACR) has joined with other provider groups in opposing a UnitedHealthcare (UHC) plan that could increase patient out-of-pocket costs.

Amgen said its sales results for Mvasi (bevacizumab) and Kanjinti (trastuzumab) give it confidence that the US market for biosimilars is more viable than generally perceived.

The strong growth of biosimilars Pfizer recently launched in the United States are part of the success story, although reference etanercept (Enbrel) sales have seen major erosion.

With a sizeable round of fresh capital, Alvotech hopes to bring monoclonal antibodies and fusion proteins through the development pipeline.

European investigators have derived a set of core principals for developing higher utilization of biosimilars.