Development

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

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.

DaxibotulinumtoxinA met all end points in a study demonstrating longer duration of action, safety, and tolerability.

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

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

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

The product would target the lucrative, billion-dollar worldwide market for Xolair.

A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.

The agreement enables Reliance Life Sciences to springboard into the US market using Medicure's commercial reach.

The Federal Trade Commission's powers to bring antitrust actions are circumscribed by public versus private and what is vs isn't "reasonable," Markus H. Meier explained.

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

Trial results demonstrated that Innovent Biologics’ bevacizumab biosimilar was effective in combination therapy with a PD-1 inhibitor in patients with hepatocellular carcinoma.

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

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

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).

The International Generic and Biosimilar Medicines Association (IGBA) seeks to limit the use of comparative clinical efficacy studies to support biosimilar equivalency applications.

Two bills in Congress meant to address the anticompetitive practice of product hopping drew fire at the American Conference Institute's annual biosimilars conference.

Much emphasis is placed on the value of congressional action to reduce prescription costs, but the Center for American Progress suggests there is an existing toolkit to accomplish this objective.

Biosimilars from Samsung Bioepis have demonstrated equivalency in clinical trial and real world settings, according to 2 prominent cancer specialists.

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.

A broader range of indications in rheumatology combined with a Canadian push for biosimilar acceptance bodes well for Merck's Brenzys product.

Courts have allowed biosimilar developers "safe harbor" against infringement suits, but there are limits, attorneys from Goodwin Proctor explain.

With anti–tumor necrosis factor (TNF) therapy showing promise in treating coronavirus disease 2019 (COVID-19), authors called for these agents to have a higher priority in research.

In the effort to find treatments for coronavirus disease 2019 (COVID-19) and related conditions, Celltrion Healthcare’s monoclonal antibody has shown promise in a phase 1 trial.

Bio-Thera said it has begun testing the safety its ustekinumab biosimilar in healthy volunteers.

The Australia-based biosimilar company hopes to compete with blockbuster programmed death-1 (PD-1) inhibitor franchises owned by Merck and Bristol Myers Squibb.

A look at efforts biosimilar manufacturers are taking to develop treatments for coronavirus disease 2019 (COVID-19).

Health technology tssessments play an important role in building confidence for use of biosimilars, yet very few meet criteria for thoroughness.