Tony Hagen

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

Breast cancer specialist Hope S. Rugo, MD, FASCO, an advisory board member for The Center for Biosimilars®, has been at the forefront of groundbreaking oncology advancements.

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

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.

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

Positive results emerging on oncology biosimilars will be presented at the European Society for Medical Oncology Virtual Congress 2020 this week .

Samsung Bioepis' bevacizumab biosimilar demonstrates equivalence in analyses to be presented at the European Society for Medical Oncology Virtual Congress 2020.

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

Product differentiation via oral formulations of biologics could be the next battleground between originators and biosimilar companies.

Oral biologics would offer many advantages over injectable drugs, and some companies believe they are on the cusp of making this happen.

Results of an analytical similarity test provide additional evidence in support of a biologics license application filed with the FDA by Amgen and Allergan.

Multiple studies indicate the nocebo effect is particularly influential in the treatment of inflammatory bowel disease (IBD), according to an opinion piece.

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.

With the launch of an adalimumab, Cadila hopes to get a piece of the worldwide biosimilar market for antirheumatic treatments.

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

The statistics show that for the Rocky Mountain province, biosimilar savings are pouring into the health care system and allowing for significantly greater access.

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.

Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.

Express Scripts, the country's largest pharmacy benefit manager, has reshuffled its preferred formulary list for 2021, giving preference to fewer pegfilgrastim products than in 2020.

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.

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

A postmarketing surveillance study of Omnitrope in pediatric patients with growth hormone deficiency sheds new light on how this agent performs relative to its reference product.

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