Allison Inserro


Bipartisan House Bill Seeks to Amend Patent Dance With Limit on Some Types of Patents

August 01, 2019

The chairman and the ranking member of the Judiciary Subcommittee on Courts, Intellectual Property and the Internet in the House of Representatives, proposed a bipartisan bill to amend the patent dance in the Biologics Price Competition and Innovation Act (BPCIA) by capping the number of some types of patents that may be claimed by the maker of the reference product.

FTC Seeking Information About J&J's Strategy for Brand-Name Infliximab, Remicade

July 30, 2019

The Federal Trade Commission (FTC) issued civil subpoenas to Johnson & Johnson (J&J) in June as part of an antitrust investigation into the contracting practices for the autoimmune drug Remicade, the originator infliximab sold by its Janssen unit, the company said in a regulatory filing on Monday.

FDA Adds Warning for Higher Dose of Tofacitinib; Researchers Report on Another JAK Inhibitor

July 26, 2019

The FDA Friday issued a black box warning for the 10-mg, twice-daily dose of tofacitinib, sold under the names Xeljanz or Xeljanz XR; the drug is an oral, small-molecule Janus kinase (JAK) inhibitor. In addition, this week researchers released phase 3 study results of an investigational JAK inhibitor, filgotinib; the drug showed a clinical response, but the researchers said additional work is needed to assess long-term efficacy and safety.

Conservative Thinkers Share Their Views for Biosimilars in a Post-ACA, BPCIA Landscape

July 24, 2019

Earlier this month, a federal appeals court heard arguments in Texas v Azar. If the judge sides with the Republican point of view that the entire Affordable Care Act (ACA) is unconstitutional and invalidates the landmark law, the Biologics Price Competition and Innovation Act (BPCIA), the pathway for biosimilars included in the ACA, would have to start over from scratch. That shouldn’t be a problem, according to 2 conservative healthcare and pharmaceutical observers interviewed by The Center for Biosimilars®.

Bipartisan Senate Bill Takes Aim at Insulin Prices

July 23, 2019

A bipartisan bill introduced in the Senate Monday calls for cutting insulin prices up to 75% via a measure aimed at insurers and pharmacy benefit managers (PBMs). The bill, introduced by Senator Jeanne Shaheen, D-New Hampshire, would prohibit PBMs and insurers from receiving rebates for insulin if the drug maker has lowered its 2020 list prices to 2006 levels.

Adalimumab, Insulin Glargine, Etanercept Top 2018 Drug Spending List

July 18, 2019

The top 3 drugs in 2018 in the United States by spending were adalimumab, insulin glargine, and etanercept, according to a study in The American Journal of Health-System Pharmacy, which also predicted that drug spending will grow 4% to 6% this year.

Multicenter European Study to Look at Real-World Experience of Patients Switched to Imraldi

July 18, 2019

A hospital for rheumatological diseases in the United Kingdom is participating in an international study that is examining real-world evidence about patient experiences after they switch from reference adalimumab (Humira) to a biosimilar, Imraldi.

House Democrats Ask US Trade Representative to Drop Biologics Language From USMCA

July 12, 2019

More than 100 House Democrats this week wrote to US Trade Representative Robert E. Lighthizer to ask him to drop language from the United States-Mexico-Canada Agreement (USMCA) trade agreement that would give 10 years of marketing exclusivity for biologic drugs.

Study Finds Characteristics Likely to Predict Conversion to AMD in Second Eye in Patients Treated With Anti-VEGFs

July 11, 2019

A secondary post hoc analysis of patients who had neovascular age-related macular degeneration (AMD) and were treated with intravitreal aflibercept or ranibizumab—2 widely used anti-vascular endothelial growth factor (anti-VEGF) therapies—found that those with certain characteristics had a substantial risk of conversion to AMD in the untreated eye.