Rheumatology

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.

Investigators said their study is valuable because biosimilar switching is likely to increase for economic reasons.

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

Investigators looked at adherence in patients who switched from reference infliximab during treatment for rheumatologic and gastrointestinal treatment.

The company is targeting the lucrative osteoporosis market dominated by Prolia, an Amgen product.

A multibiomarker disease activity score looks at serum protein activity for a more sensitive evaluation of biosimilarity, investigators said at the American College of Rheumatology Convergence 2020 meeting.

Poster presentations at the American College of Rheumatology (ACR) Convergence 2020 meeting shed light on performance of adalimumab versions.

Separate studies including one on application methods for CT-P17 were reported at the American College of Rheumatology Convergence 2020 meeting.

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).

Expecting real-world evidence to confirm safety and efficacy of biosimilars is asking too much, Uwe Gudat, a pharmacovigilance expert from Fresenius Kabi, said at the Terrapinn Festival of Biologics Basel 2020.