Policy

The Therapeutic Goods Administration has announced that it will not use 4-letter suffixes in naming biologic and biosimilar medicines (as the FDA currently requires).

Trump said of Azar, who was confirmed by a vote of 55 to 43 on January 24 to replace Tom Price, MD, as Secretary of HHS, “He’s going to get those prescription drug prices way down…it’s going to come rocketing down.”

On January 26, the Biosimilars Council (a division of the Association for Accessible Medicines) filed an amicus brief opposing Johnson & Johnson’s motion to dismiss a complaint brought by Pfizer over its biosimilar infliximab, Inflectra, which references Johnson & Johnson’s innovator product, Remicade.

Healthcare spending for the Medicaid expansion population increased steadily over time for beneficiaries who remained enrolled in Medicaid, according to a new analysis from Avalere Health. The analysis also found that spending for prescription drugs increased over the study period, with pharmacy costs (excluding prescription drug claims for hepatitis C treatments) almost doubling over the 2.5-year time period during which the cohort was tracked

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 22, 2018.

The European Medicines Agency (EMA) has launched a survey of pharmaceutical companies to assess their preparedness for the United Kingdom’s upcoming withdrawal from the European Union, as it hopes to identify any concerns about the continued supply of drugs during the Brexit transition.

The report from Trinity Partners details findings from qualitative research with 10 medical directors at US payer organizations, representing plans covering over 100 million commercial and Medicare enrollees in the United States.

Congress has passed a short-term spending package that will fund the government through February 8, 2018, and allow the FDA to resume normal operations.

The Brazilian Society of Clinical Oncology has released its official position on the use of biosimilars in oncology. Thus far, only 2 oncology biosimilars (filgrastim and trastuzumab) have been approved for use in Brazil, though the number of applications filed with the National Health Surveillance Agency is expected to grow steadily in the coming years.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 15, 2018.

On January 11, Celltrion and its partner Teva filed 2 new lawsuits against Genentech in a California district court.

The United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) announced yesterday that it will not make any sudden changes to the nation’s regulatory framework following the country’s exit from the European Union.

Three European nations are amending their policies in order to create better conditions for biosimilar uptake and the cost savings that biosimilars provide to health systems.

MedPAC called for changes to Medicare Part D to remove the financial disincentives that block the use of lower-cost biosimilar therapies.

Innovator drug developer Genentech, maker of the biologic therapies Avastin (bevacizumab) and Rituxan (rituximab), faces challenges from biosimilar developers in the United States and abroad. This week saw developments in cases concerning both molecules in US and Japanese courts of law.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 8, 2018.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains how "fail-first" policies, or step therapy, affect patients.

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of January 1, 2018.

AbbVie is increasing Humira's price by 9.7%. That price increase could add $1.2 billion to the US healthcare system’s drug costs in 2018, according to one analyst.

On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.

Can lower cost biosimilars create a policy solution for seniors enrolled in the Medicare Coverage Gap Discount Program?

The Center for Biosimilars recaps the most-read articles of 2017.

Elan Rubinstein, PharmD, MPH, voiced his frustration with the lack of presence the pharmacy profession has had in the negotiations of repealing and replacing the Affordable Care Act.

The Center for Biosimilars recounts 4 of the top legal developments in the biosimilars space during 2017.

Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries, and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients.

2017 brought a number of notable guests to The Center for Biosimilars®. Here are the most-watched interviews of the year.

The Center for Biosimilars recaps the the top 5 articles for the week of December 18, 2017.

The US Government Accountability Office (GAO) reports that retail drug spending accounted for about 12% of total personal healthcare service spending in the United States in 2015, up from about 7% through the 1990s.

Developments at the FDA and greater physician acceptance of biosimilars made 2017 a banner year for emerging therapies, according to James Stevenson, PharmD, FASHP, professor of clinical pharmacy at the University of Michigan College of Pharmacy.