Rheumatology

Three-fourths of patients who reverse-switched to originator infliximab from CT-P13 benefited, although it wasn't clear why the biosimilar treatment "failed."

Biosimilar competition took a big chunk of revenue from Roche's aging blockbusters in 2020, and the company is banking on its newer medicines to drive fresh revenue growth.

Physician specialty and practice setting each play a significant role in whether biosimilars are administered vs originators, according to a large, cross-sectional study.

Celltrion aims to try a direct marketing approach in Canada to streamline sales of its subcutaneous form of Remsima.

Amgen described how a double-edged biosimilars sword has worked for and against the company's profit margin.

HoUng Kim, PhD, head of the Medical and Marketing Division at Celltrion Healthcare, discusses how the company’s adalimumab biosimilar candidate, CT-P17, stands out from the competition.

Guangzhou, China-based Bio-Thera has filed a biologics license application (BLA) with the FDA for the approval of bevacizumab biosimilar candidate BAT1706.

In its annual drug price guide, Vizient predicts that US annual adalimumab (Humira) revenues could reach $24 billion before biosimilars enter the marketplace.

The study of originator infliximab and SB2 used nurses as the first point of contact when educating patients, relying partly on patient trust in these health care professionals.

It took Henlius years to get a rituximab biosimilar approved in China. Now, that process could be cut in half, owing to significant regulatory reforms.

Consistency of reporting quality attributes for biosimilars may differ, complicating the job of getting a full picture of biosimilarity.

Coherus BioSciences CEO Dennis M. Lanfear discusses the company's biosimilar marketing prospects in 2021.

CMS looks to speed up health information transfer by putting faxes in the past. It also aims to set deadlines for payers to respond to prior authorization requests.

Lawrence A. Hill, PharmD, MBA, RPH, BCPS, provided an insider's view of the rapidly changing biologics and biosimilars market and regulatory structure in China.

Authors of a review found that biosimilar uptake and market share are not in themselves sufficient to establish whether these agents will lead to savings.

Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched.

An expansion of its Reykjavik, Iceland, headquarters operation will speed the company on its way to launching its first biosimilars, officials said.

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

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.

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.

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

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

Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.

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.

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

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

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.

Bincy P. Abraham, MD, explains that even when payers allow coverage for biosimilars, providers may still be hesitant to use them.

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