Kelly Davio

December 23, 2019

It has been hypothesized that metalloproteinases, and particularly MMP3, could a have a role in degrading anti–tumor necrosis factor drugs, leading to treatment failure in patients with inflammatory bowel disease (IBD).

December 20, 2019

The World Health Organization (WHO) this week prequalified its first biosimilar. The product, Samsung Bioepis’ biosimilar trastuzumab, Ontruzant, referencing Herceptin, could now become available to more patients with HER2-positive cancer in low- and middle-income countries.

December 19, 2019

Using a biosimilar can produce substantial cost savings in patients who are receiving infliximab therapy for inflammatory diseases like rheumatoid arthritis (RA), but dose escalations, which are frequent for those who use infliximab, can increase the cost of therapy, even with a biosimilar.

December 18, 2019

Previously, such chemically synthesized polypeptide products were excluded from the regulatory transition, so subsequent-entry products referencing these drugs would not be eligible for biosimilars or interchangeable product approval. Such products would also not be eligible for generic drug development.

December 17, 2019

Pfizer gained FDA approval for its biosimilar trastuzumab, Trazimera, in March 2019, and is slated to launch in the United States on February 15, 2020. Ahead of that milestone, researchers last week reported long-term safety and overall survival (OS) data for the Herceptin biosimilar in patients with HER2-positive metastatic breast cancer.

December 16, 2019

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

December 14, 2019

Outlook Therapeutics, formerly known as Oncobiologics, said this month that it has reached an agreement with the FDA on 3 special protocol assessments for clinical trials of ONS-5010, a formulation of bevacizumab intended to treat retinal diseases.

December 13, 2019

On Thursday, the Senate voted to confirm Stephen Hahn, MD, FASTRO, chief medical executive at the University of Texas MD Anderson Cancer Center, as the 24th commissioner of the FDA.

December 12, 2019

During this week’s annual meeting of American Society of Hematology, researchers from Canada reported that using biosimilar filgrastim could result in substantial savings.

December 11, 2019

An agreement on the United States–Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.