Policy

FDA Commissioner Scott Gottlieb, MD, has unveiled a new plan to facilitate increased competition in the prescription drug market through approval of more lower-cost, generic medications.

Denmark is the first nation in Europe—and in the world—to switch all well-treated rheumatoid arthritis patients from reference infliximab (Remicade) to the biosimilar Remsima, and 1 early study suggests that the switch has been successful. Patients, however, have needed convincing.

Lawmakers are contemplating a substantial range of reforms to make biologics more affordable for patients.

States have taken the lead in advancing strategic policies and programs to attract, retain, and grow an innovative biopharmaceutical presence in the United States, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents leading US biopharmaceutical research companies.

News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.

The Institute for Clinical and Economic Review (ICER) has issued a report recommending that dupilumab (Dupixent) offers good long-term value and important clinical benefit for patients with moderate-to-severe atopic dermatitis.

A recent QuintilesIMS report shows that biosimilars have led to reductions in the price of biologics in Europe. Our infographic shows 4 key takeaways from the study.View the infographic or read more about the report here.

The US biopharmaceutical industry faces mounting global competition from countries in the developing world and Europe that are increasingly implementing pro-innovation programs and strategies in the sector, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA)

FDA Commissioner Scott Gottlieb, MD, said that the agency is examining how to push drug applications to “the front of the line” when there are fewer than 3 competing manufacturers for generic versions of a particular medication.