News

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.

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.

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.

There are diverging opinions on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

Average clinical efficacy testing cost millions of dollars more for phase 3 biosimilar studies than for pivotal studies of originator products, authors report.

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

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.

Here are the top 5 biosimilar articles for the week of October 5, 2020.

Simplified standards for biosimilar approvals in the United Kingdom may open the door to broader changes.

The FDA has had to rely on triaging to address its most critical priorities during the unfolding coronavirus disease 2019 (COVID-19) pandemic, according to Peter P. Stein, MD.

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 European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.

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

Researchers contend the "totality of evidence" for biosimilar approval may be sufficient to demonstrate interchangeability.

During the coronavirus disease 2019 (COVID-19) pandemic, patients are more likely to have delayed cancer screenings rather than their doctors and clinics.

Accord brought 2 biosimilars referencing blockbuster oncology products to the United Kingdom and amended its agreement with Shanghai Henlius Biotech.

Here are the top 5 biosimilar articles for the week of September 28, 2020.

Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia

Centus’ Equidacent became Europe’s fourth bevacizumab biosimilar to receive marketing authorization.

Over the past decade, savings from biosimilars have grown; however, there remain barriers that prevent biosimilar savings from reaching their full potential, according to a report from the Association for Accessible Medicines.

September saw several biosimilar regulatory advances despite 2020 being a slow year for biosimilar approvals and launches.

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.

Germany could eke out more gains from biosimilars on top of its already impressive savings, investigators write.

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

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.