Business

Innovent Biologics Gains NMPA Approval for Additional Sulinno Indications

December 31st 2020

By Tony Hagen

China's National Medical Products Administration (NMPA) has cleared Innovent Biologics' adalimumab biosimilar for more indications.

A Review of the Most-Read Biosimilar Stories of 2020: Part 2

December 27th 2020

By Tony Hagen

Article

In part 2 of this year-end feature, we look at the most-read biosimilar stories of the second half of 2020.

Pandemic Delays FDA Decision on Biocon's Bevacizumab Application

December 26th 2020

By Tony Hagen

Article

MYL-14020 could have been the fourth US biosimilar approved by the end of 2020, but the FDA hasn't been able to complete a necessary foreign inspection, owing to the pandemic.

A Review of the Most-Read Biosimilar Stories in 2020: Part 1

December 24th 2020

By Tony Hagen

Article

The top stories in biosimilars for 2020 encompassed biosimilar approvals and launches, the coronavirus disease 2019 pandemic, and the FDA's challenge to stay on top of the rapidly changing health care landscape.

Amgen's Bourdon Discusses Riabni Rollout in the United States

December 23rd 2020

By Tony Hagen

Article

Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar.

AMCP Sets a Course for Biosimilar Promotion

December 22nd 2020

By Tony Hagen

Article

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

Bio-Thera Seeks to Enter Brazilian Market for Bevacizumab

December 20th 2020

By Tony Hagen

Article

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

Samsung Bioepis Examines European Awareness of Biosimilars

December 19th 2020

By Tony Hagen

Article

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

Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar

December 18th 2020

By Tony Hagen

Article

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

FDA Approves Rituximab Biosimilar "Riabni" From Amgen

December 17th 2020

By Tony Hagen

Article

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