Gastroenterology

Biosimilars get short shrift in a proposed pricing model developed by the Drug Pricing Lab at Memorial Sloan Kettering (MSK), experts say.

Animal toxicology studies contribute little to demonstrations of biosimilarity and yet these studies frequently must be done to satisfy international regulatory requirements, investigators conclude.

Biosimilars are intended to save money for the health care system, but for many reasons, they are not succeeding in this mission, Harvard authors argue.

Following lackluster experience with biosimilar marketing in the United States, Merck moves forward with spinoff plan.

Alvotech closes on $35 million in funding, and Samsung Bioepis gets closer to marketing an adalimumab biosimilar. Alvotech's planned high-tech expansion is pictured.

The Senate has passed a bill requiring the FDA to provide educational information that supports and promotes the adoption of biosimilars.

Minnesota legislators introduce what could possibly become the first law to curtail payers' rights to determine which biologics patients have access to.

Regulatory and launch news on rheumatology biosimilars for adalimumab and infliximab was plentiful in February 2021.

Biocon and Viatris edge closer to EU marketing authorization for a bevacizumab biosimilar, among other biosimilar business developments.

Biosimilars have come a long way, and their path has mirrored that of generics—fraught with obstacles. Still, a stronger embrace is needed from physicians and payers.

Gary H. Lyman, MD, PhD, provides an expert overview on overcoming the challenges of discussing biosimilars with patients.

Coherus BioSciences filed a 351(k) biologics license application (BLA) for CHS-1420, an adalimumab biosimilar candidate.

The launch of Hyrimoz gives Sandoz 5 biosimilars on the Canadian market. National policies on switching have given biosimilars a tailwind.

Patient characteristics are predictive of whether a switch to a biosimilar is likely to be accepted, investigators found.

A long-term observational study suggests a non-medical switch from infliximab to SB2 is “a feasible option” for patients with inflammatory bowel diseases (IBD).

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

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.

Investigators looked at the first 9 months of use following the launch of the bevacizumab biosimilar Mvasi to gauge physician comfort with this agent across tumor types.

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.