Business

Prestige Biopharma and Teva Israel join forces to bring a trastuzumab biosimilar to the Israeli market.

HHS Secretary Alex M. Azar said efforts and policies to counter a sharply upward drug price trend have been successful, in a talk with the Association for Accessible Medicine.

Biocon Biologics nets a $150 million investment from Goldman Sachs to further its development and marketing of biosimilars.

Formycon and Bioeq say resubmission of the biologics license application for their ranibizumab candidate will not affect launch timing in US or European markets.

Launched in the US market in late 2019, Truxima (rituximab) has become a significant revenue driver for Teva.

Biosimilar orphan drugs might not be cheaper than innovator orphan products, owing to multiple factors, but modifications to regulatory policy could change this, a presenter said at the Terrapinn Festival of Biologics Basel 2020.

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®.

Companies continued to prove in October that rare regulatory approvals and a pandemic have not stopped them from moving forward with plans to further products and search for ways to save money.

A collaboration with the FDA could lead to new forms of pharmacodymamic measurement that improve speed and efficiency of biosimilar development and approval.

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.

Chad Pettit, MBA, executive director of marketing and team leader for global biosimilar launches at Amgen, discussed Amgen’s recent report on the state of the US biosimilars marketplace.

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.

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

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

Roche attributes a $3.83 billion reduction in sales to biosimilar competition.

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

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

Ryan Cox, vice president of the Access Experience Team at PRECISIONvalue, discusses whether midsize employers can participate in payer discussions on formulary placement.

Ryan Cox, vice president of the Access Experience Team at PRECISIONvalue, discusses what employers can do to encourage biosimilar uptake and what cultural changes are needed to make it happen.

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.

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

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.

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

Singapore-based PrestigePharma presents fresh equivalency data supporting its case for regulatory approval of HD201.