Gastroenterology

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.

A need for clinical evidence on the efficacy and safety of infliximab switching led the authors to pursue this investigation.

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.

Among patients treated for metastatic breast cancer, 40% switched to ABP 980.

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.

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

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.

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.

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.

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.

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.

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

Amgen's 2020 biosimilar report goes into detail on market share and costs for biosimilars across the therapeutic spectrum in the United States.

Alexion and Celltrion separately announce advances in their drug development and marketing efforts.

Sometimes the reference product exhibits pricing resistance against the competitive effect of biosimilars, according to a Pharmaceutical Strategies Group report.

California has become the first state to implement a policy to produce and distribute its own drug products to help lower costs.

An advance is notched for the ravulizumab (Ultomiris) follow-on product from Alexion. Clinical findings in atypical hemolytic uremic syndrome (aHUS) are provided.

A diverse panel from practice, payer, and wholesale perspectives convened at The American Journal of Managed Care®'s Patient-Centered Oncology Care® 2020 virtual conference to hash out one of the hottest issues in biosimilar availability right now.

The Committee for Medicinal Products for Human Use (CHMP) recommendation for ravulizumab (Ultomiris) is for a dosage that involves a less rigorous schedule for administration.

Lotus and CKD Pharmaceutical intend to be among the first to bring a darbepoetin alpha biosimilar to Southeast Asia.

Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.

An upcoming webinar from MJH Life Sciences™ will address the payer rebate deals that limit provider choice of biosimilars and complicate clinical pharmacy operations.