Policy

On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.

Even as the industry awaited news of the Supreme Court’s ruling in the case of Sandoz v Amgen, many legal experts at the 8th Annual Summit on Biosimilars earlier this month were focused on inter partes review as an alternative to patent litigation under the contentious Biologics Price Competition and Innovation Act.

State lawmakers are pushing legislation to advance automatic biosimilar substitution at a rapid pace across the nation—33 states and Puerto Rico have already taken action, and 8 more states have bills pending, according to Stephanie Hoops, a market analyst at Decision Resources Group.

The Senate Republicans’ bill to repeal and replace the Affordable Care Act would result in the loss of health insurance for 22 million Americans in 2026 relative to the number who would be insured under current law, according to the nonpartisan Congressional Budget Office’s report.

As patients, policy makers, and providers alike wait to learn the fate of the contentious new Senate healthcare bill, some stakeholders suggest that existing legislation—dating back to the 1980s—could potentially play a role in driving down prescription drug costs.

Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer. As a recent position paper by the European Society for Medical Oncology (ESMO) points out, the anticancer market is expected to pass the €140 billion (apx. $157 billion) by 2020.

The Senate today revealed its long-anticipated healthcare reform bill, The Better Care Reconciliation Act of 2017. Like the House bill, the Senate legislation leaves some features of the ACA intact, including the BPCIA.

After negotiations with drug manufacturer Roche, England’s National Health Service (NHS) has approved the routine use of trastuzumab emtansine (Kadcyla) for the treatment of HER2-positive metastatic breast cancer in patients for whom trastuzumab (Herceptin) treatment has failed.

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.