The Center for Biosimilars Staff

July 16, 2019

The FDA has released updated draft guidance on population pharmacokinetics (PK). The update follows draft guidance originally put forth by the agency in 1999.

July 15, 2019

A recent study found no difference in the risk of developing atrial fibrillation (AF) or major adverse cardiovascular events (MACE) associated with ustekinumab versus anti–tumor necrosis factor (anti-TNF) therapy in patients with psoriasis or psoriatic arthritis.

July 15, 2019

Six months after launching its biosimilar pegfilgrastim, Udenyca, Coherus BioSciences announced that it has produced more that 400,000 prefilled syringes of its product.

July 14, 2019

As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.

July 13, 2019

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

July 12, 2019

Samsung Bioepis, developer of the biosimilar trastuzumab, Ontruzant, and Genentech, maker of the reference trastuzumab, Herceptin, have asked a court to dismiss their patent litigation.

July 11, 2019

The Trump administration has withdrawn its proposal to block rebates and discounts given by drug makers to pharmacy benefit managers, Part D plans, and Medicaid managed care organizations.

July 08, 2019

Singapore-based Prestige BioPharma has entered into 2 new agreements related to its proposed biosimilar trastuzumab, HD201, which it hopes to sell under the brand name Tuznue.

July 06, 2019

A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.

July 04, 2019

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.