Regulatory

Trade associations and companies in the biosimilars business ask the FDA to hone its proposed study on product disclosures.

The random jumble of letters that the FDA attaches to new biologics and biosimilars plays a big role in patient acceptance of these drugs, investigators report.

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

Some European markets are more formidable than others with regard to complexity and getting biosimilars established, but there are good places to start, Jonathan Sweeting, head of Europe for Samsung Bioepis, explains.

It’s same old, same old when it comes to pharmacy benefit manager (PBM) contracts despite much touted reforms, authors of a review contend.

For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to clinch the marketing aspect.

Coronavirus disease 2019 altered the workflow in all areas of the health care and life sciences industries, and the FDA was not exempt from pandemic-induced upheaval.

The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, chose a leader with a research, public relations, and strategic planning background.

Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.

Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.

From China to Taiwan, BeiGene and Bio-Thera Solutions hope to capture a large share of the bevacizumab biosimilar market.

Multiple contenders are lining up for the pending expiration of patents on the blockbuster Regeneron reference product for wet age-related macular degeneration.

The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.

Samsung Bioepis' latest approval gives it 5 biosimilar approvals in the European marketplace.

After receiving regulatory approval in June, Sandoz launched 2 of its biosimilars on the Canadian market.

Monoclonal antibodies may play a frontline role in dealing with COVID-19 infections, according to Anthony S. Fauci, MD.

US administrative and legislative efforts are moving the United States and Germany more into alignment on drug cost management philosophy, according to a review.

A Pacific Research Institute economist says that by his scorecard, biosimilars are not supercharging the market the way they ought to be doing .

Pharmacists in Ireland say the country is losing out on hundreds of millions of dollars in savings owing to the absence of a biosimilar substitution policy.

There has been an outpouring of advocacy tugging biosimilars into the marketplace, and market share of these lower-cost drugs has increased.

Up-and-coming Henlius Biotech consolidates its footing in the biosimilar world with another regulatory approval.

Celltrion finds fault with a critique of equivalence margins used to approve its infliximab biosimilar.

Defining biosimilar use in the United States as "sluggish," Juliana Reed, MS, said employers have to get involved.

Opening the door to biosimilar competition starts with breaking down the patent barrier, says Christine Simmon, JD.

United States Pharmacopeia (USP), the FDA, and others deliver constructive critique on how India can bolster quality in its biopharmaceutical industry.

Samsung Bioepis makes a move into the promising Brazilian market for biosimilars, which data suggest is one of the fastest-growing biosimilars markets among emerging nations.

Biosimilars have improved access to health care in India, but many effective new drugs are high priced and patented, and authors of a new study recommend interventions to make these available, too.

Despite there being concerns over the safety of nonmedical switching between a reference product and a biosimilar, there is a growing body of evidence supporting the safety of switching, according to an executive of Sandoz, which produces biosimilars.