Regulatory

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

The Committee for Medicinal Products for Human Use (CHMP) recommendation for ravulizumab (Ultomiris) is for a dosage that involves a less rigorous schedule for administration.

The United States has missed out on almost $20 billion in savings as a result of not having a competitive biosimilar market, according to findings from the Pacific Research Institute.

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

Much of the groundwork for establishing equivalence is established in the pharmacokinetic evaluation. Further studies add less and less to the body of evidence for biosimilar approval, UK regulators write.

Celltrion moves another step forward in its bid to get a coronavirus disease 2019 (COVID-19) treatment on the market.

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

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.

Representative Glenn Grothman, R-Wisconsin, says interchangeability for insulins makes sense based on the savings potential and safety record of these agents.

Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.

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 .