Rheumatology

Manufacturers, not regulators, may be the holdouts when it comes to eliminating comparative clinical efficacy trials, according to experts interviewed by The Center for Biosimilars®.

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.

The American College of Rheumatology (ACR) has joined with other provider groups in opposing a UnitedHealthcare (UHC) plan that could increase patient out-of-pocket costs.

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.

The strong growth of biosimilars Pfizer recently launched in the United States are part of the success story, although reference etanercept (Enbrel) sales have seen major erosion.

With a sizeable round of fresh capital, Alvotech hopes to bring monoclonal antibodies and fusion proteins through the development pipeline.

A study of mandatory switching for patients with rheumatologic conditions led to savings without effect on safety or efficacy.

A retrospective analysis of data from the US Veterans Affairs Healthcare System database provides positive switching data for infliximab products.

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

Biocon had a busy quarter, which included the launch of a long-acting insulin glargine product (Semglee) in partnership with Mylan.

Earnings fell overall for Biogen, although biosimilar revenues continued an upward climb.

Demonstrated biosimilarity across clinical parameters puts this drug among NeuClone's leading product candidates.

Investigators note similar efficacy and safety profiles in real-life study of reference and biosimilar forms of rituximab.

An Avalere analysis suggests costs are more moderate and lower under a no–step therapy scenario for patients with Crohn disease.

Reviewers found that costs of reference infliximab and its biosimilars make it the most cost-effective therapy for ulcerative colitis (UC) among targeted immune modulators.

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

The US Public Interest Research Group (PIRG) contends AbbVie's patent thicket for Humira (adalimumab) will encourage anticompetitive practices by other manufacturers.

Celltrion Healthcare reports on progress with higher predose levels of the infliximab biosimilar Remsima in patients with Crohn disease (CD) and ulcerative colitis (UC).

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

As the United States continues to struggle to increase biosimilar uptake, presenters at the DIA 2020 Biosimilars Conference offered insight into what other countries have done to encourage biosimilar use.

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

Some acts by companies in the biologics marketplace may go too far in preventing free market activity, according to Markus H. Meier, acting director for the Federal Trade Commission (FTC) Bureau of Competition.

A secretive biosimilars company notches yet another co-licensing deal but withholds full details.

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 NOR-SWITCH study showed comparable safety, efficacy, and immunogenicity for patients with inflammatory bowel disease (IBD) who switched from reference infliximab to Celltrion biosimilar (CT-P13).

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

Amgen's Onpro autoinjector device for pegfilgrastim is a stunning example of how product differentiation via drug delivery devices can protect market share in the biologics market.

The American College of Physicians (ACP) said many reforms are needed to install appropriate checks and balances in the biologic drugs marketplace.

Many patients with rheumatic diseases are unsure whether their prescriptions are biosimilars, suggesting more efforts in patient education are needed.