Kelly Davio

May 14, 2018

Mylan’s insulin glargine follow-on, MYL-1501D, referencing Sanofi’s Lantus, is a long-acting human insulin analogue that allows for once-daily basal use in patients with type 1 diabetes. The drug has been authorized for marketing as a biosimilar insulin in the European Union and in Australia under the brand name Semglee.

May 14, 2018

In an effort to accurately predict an individual patient’s response after starting or tapering an anti–tumor necrosis factor (anti-TNF) agent, researchers from the Netherlands, reporting findings in Rheumatic and Musculoskeletal Diseases, explain that calprotectin has some predictive value for clinical response in patients starting anti-TNF treatment, although it was not predictive of clinical response after tapering.

May 12, 2018

HHS’ “American Patients First” blueprint for implementing Trump’s vision includes a proposal to address the potential misuse of Risk Evaluation and Mitigation Strategy programs to delay biosimilar competition.

May 10, 2018

In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."

May 09, 2018

The United States Patent and Trademark Office (USPTO), in a proposed rule published today on the Federal Register, seeks to amend the rules for inter partes review proceedings, and similar proceedings, before the Patent Trial and Appeal Board.

May 09, 2018

Antibodies that deplete B cells, including rituximab, have demonstrated efficacy in the treatment of neurological conditions such as progressive multiple sclerosis and neuromyelitis optica spectrum disorder. The efficacy of these treatments hinges on adequate B-cell depletion, but there is a lack of standardization in treatment and monitoring protocols to guide clinical practice.

May 08, 2018

The report’s authors assessed commercial plan coverage and formulary design concerning biosimilars for the top 25 payers—covering approximately 189 million lives—in the United States, using publicly available policies.

May 04, 2018

While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.

May 03, 2018

Biosimilar developer Biocon has received the FDA’s Form 483 after a preapproval inspection of its Bangalore manufacturing facility resulted in 7 observations. The FDA issues Form 483 when an investigator conducting an inspection has observed conditions that may constitute violations of the Food, Drug, and Cosmetic Act or related acts.

May 03, 2018

Sandoz has announced that it has received a Complete Response Letter from the FDA for GP2013, its proposed rituximab biosimilar referencing Rituxan.