Tony Hagen

A partnership forum sponsored by the Academy of Managed Care Pharmacy (AMCP) yielded numerous ideas for improving access to biosimilars.

Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.

In the EU-5 group of countries, biosimilar awareness is poor, hindering uptake of these potentially cost-saving medicines, a white paper states.

The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.

The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020.

Samsung Bioepis hopes to gain regulatory approval for a denosumab biosimilar referencing Prolia. The trial will focus on women with postmenopausal osteoporosis.

In little over 1 year of use in patients with breast cancer, trastuzumab biosimilars have seen rapid growth in uptake.

The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected to be followed by a European Commission final decision early in 2021.

Health care policy expert Jane Halton, AO, PSM, has been picked for her extensive experience in governmental health affairs.

The recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) bodes well for a final marketing authorization for the adalimumab biosimilar candidate.

Two studies of trastuzumab biosimilars have improved understanding of these medicines as monotherapy and in combination with other agents in metastatic breast cancer.

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.

Anurag S. Rathore, PhD, wins a grant and the use of scientific instruments from Agilent to further his investigation.

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 Songdo district of Incheon, Republic of Korea, is rapidly becoming a major biopharmaceuticals production center.

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.

The European Commission (EC) said it will take the lessons learned from the coronavirus disease 2019 (COVID-19) pandemic and build a better marketplace for generics and biosimilars.

Christopher Hansung Ko, PhD, president and CEO of biosimilars company Samsung Bioepis, discusses innovations and precautions the pandemic has brought to the field of biosimilars.

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.

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.

Meaghan Rose Smith's appointment comes during a time of challenges for the biologics industry.

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

The FDA naming convention and its utility are not well understood, and “poor” biosimilar knowledge may be partly to blame, investigators report.

The rheumatology and gastroenterology biosimilar candidate would enter the lucrative market established by Humira.