Allison Inserro

February 28, 2019

A California legislator wants to make the state the first to bar “pay-for-delay” tactics used by drug companies to prevent competition, targeting both generics and biosimilars, in a move that would create the first piece of state law about this issue.

February 27, 2019

Researchers say they validated whole blood expression of a gene involved in inflammatory response as an accurate biomarker predicting response to anti–tumor necrosis factor (TNF) for endoscopic remission in patients with Crohn disease (CD) and ulcerative colitis (UC), both types of inflammatory bowel disease (IBD) in a finding that could assist in deciding whether biologic-naïve patients should receive anti-TNF therapy.

February 25, 2019

As part of its investigation into drug pricing, the Senate Finance Committee is launching a bipartisan probe into insulin prices, while a Democratic congressman from Vermont announced a bill to allow the importation of insulin from Canada and other countries.

February 23, 2019

Newly published research reports on an analytical characterization of Samsung Bioepis’ biosimilar adalimumab, SB5, in comparison with the reference, Humira, using 3 different guidelines, showed that the 2 products are largely similar, and any of the minor differences are not clinically meaningful.

February 21, 2019

More payers began to significantly adjust their reimbursement strategies for biosimilars last year, according to pharmacy benefit manager (PBM) Magellan Rx Management.

February 21, 2019

The World Health Organization has long recognized the need for a global harmonization of standards for biologics worldwide. In response, the United Kingdom's National Institute for Biological Standards and Control has developed the first international standard for infliximab.

February 19, 2019

Pfizer received authorization from the European Commission for its bevacizumab biosimilar, PF-06439535, to be sold under the trade name Zirabev for the treatment of certain advanced cancers: carcinoma of the colon or rectum, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.

February 18, 2019

A study of cost trends for tumor necrosis factor (TNF) inhibitors for rheumatoid arthritis (RA) after the entry of new competition showed that the newer drugs did not lower costs, and in fact, the annual treatment costs of the existing medicines rose by $17,390. Taxpayer funds shouldered all of the increases, and the “findings illustrate a market failure contributing to the rising costs of prescription drugs,” according to the researchers.

February 16, 2019

The FDA released draft industry guidance for its pathway aimed at providing incentives to stimulate competition for branded drugs that have few or no generic counterparts in the marketplace. Separately, it also updated its “name and shame” list.

February 14, 2019

The FDA this week announced draft guidance that would allow stakeholders to propose pharmaceutical quality standards for potential informal recognition to increase efficiency in drug development by achieving “voluntary consensus standards.”