News

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.

Here are the top 5 biosimilar articles for the week of September 14, 2020.

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.

Many patients with rheumatic diseases are unsure whether their prescriptions are biosimilars, suggesting more efforts in patient education are needed.

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.

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

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

With anti–tumor necrosis factor (TNF) therapy showing promise in treating coronavirus disease 2019 (COVID-19), authors called for these agents to have a higher priority in research.

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

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.

In the effort to find treatments for coronavirus disease 2019 (COVID-19) and related conditions, Celltrion Healthcare’s monoclonal antibody has shown promise in a phase 1 trial.

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

Here are the top 5 biosimilar articles for the week of September 7, 2020.

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.

With multiple biologics nearing the end of their patent exclusivities, biosimilar developers are branching out.

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.

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

This summer, The Center for Biosimilars® interviewed several experts for their opinions on the current need for biosimilars and how companies are working to overcome barriers to uptake. Here are some highlights.

Here are the top 5 biosimilar articles for the week of August 31, 2020.

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

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.

Authors of a report on Medicare spending trends said there’s more to controlling the affordability of insulin than instituting out-of-pocket (OOP) caps.

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