News

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.

July 13, 2017, is the day for the review of FDA’s Oncology Drug Advisory Committee (ODAC) will review biologics license applications for biosimilars to trastuzumab (Herceptin) and bevacizumab (Avastin).

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.

Today, Sanofi and Regeneron announced that the European Commission has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis, and which outperformed Humira in a phase 3 trial.

Sandoz announced today that is has received approval from the European Commission for its biosimilar etanercept (which will be marketed as Erelzi) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, axial spondyloarthritis, psoriasis, and psoriatic arthritis.

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.

Earlier this month, Biocad obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras. The product, USMAL, will be available to patients within months. Yet the Russian firm sees roadblocks ahead for US market entry.

The Biologics Prescribers Collaborative released its comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability, and made 5 key requests.

A recent study presented at EULAR found that a substantial number of patients who switched treatment from reference etanercept to a biosimilar switched back to the reference after a short period.

The FDA rejected, for a second time, Pfizer’s application for approval of its biosimilar epoetin alfa (Epoetin Hospira), a colony-stimulating factor indicated for anemia, biosimilar to Epogen and Procrit.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion Biogen’s adalimumab biosimilar, SB5 (also known as Imraldi), referencing Humira.

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.

Spanish researchers recently reported reliable detection of antibodies to infliximab (ATI) from venous or capillary blood using a rapid, point-of-care (POC) ATI test that allowed clinicians to detect ATI in a quick, decentralized mode that facilitated immediate POC decision making.

Worldwide prescription drug sales could reach $1.06 trillion by 2022, according to a new report. This earning represents only a 6.5% compound annual growth rate, and biosimilars may well play a significant role in curbed growth.

At the 8th Annual Summit on Biosimilars, a panel of legal experts reviewed lessons learned from the first 18 months of biosimilars in the United States, and looked ahead to the question of how these drugs will gain acceptance and market uptake.

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application for denosumab.

Pharmaceutical manufacturers, pharmacy benefit managers, and various trade groups respond to the recent Supreme Court decision on the 6-month marketing rule post FDA approval for biosimilars.

In a recent study, researchers sought to investigate the clinical impact of 1-year certolizumab pegol therapy added to the first year of a 2-year treatment with methotrexate in patients with early rheumatoid arthritis.

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.

Sandoz announced today that its biosimilar rituximab product has been approved by the European Commission to treat blood cancers and immunological diseases.

A viewpoint published in JAMA explains why biosimilar drugs approved in the United States for the treatment of chronic diseases may not result in expected cost savings.

A new survey of 47 healthcare C-suite executives found that drug spending has increased among healthcare leaders. That trend, the report’s authors say, will only increase in the coming years, and health system leaders will need strategies to cope with the burden.

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

Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.