News

Navigator programs, which provide outreach, education, and enrollment assistance to consumers eligible for health coverage through the Affordable Care Act marketplace and Medicaid, learned on August 31, 2017, about a 40% CMS spending cut on the program, with a wide disparity in funding cuts per state.

Judge William C. Bryson has ordered Allergan to file a brief for a federal patent infringement case by Friday, October 13, after questioning whether the drug maker’s recent transfer of drug patents to a sovereign tribe was a “sham.”

The European Union, considered the most seasoned user of biosimilars, has approved the highest number of biosimilars worldwide.

Insurance companies and pharmacy benefit managers use step-therapy policies to require doctors to prescribe older, less expensive drugs first, which patients must fail to respond to adequately before they become eligible for newer, more expensive treatments.

Last week, Amgen filed a new lawsuit against Genentech in a California district court. The suit seeks a judgment that Amgen’s newly FDA-approved bevacizumab biosimilar, bevacizumab-awwb (Mvasi) has not infringed and will not infringe on 27 patents for Genentech’s reference bevacizumab treatment, Avastin.

The FDA has issued a Complete Response Letter for Mylan and Biocon’s pegfilgrastim biosimilar, MYL-1401H, referenced on Neulasta.

UK trade group The Association of British Pharmaceutical Industry announced last week that the Administrative Court has denied its application for judicial review of a new National Health Service drug pricing policy.

Amazon may be in the final phase of its decision to enter the online prescription drug sales market, according to analysts. Although Amazon has declined to comment, experts believe the company will decide before Thanksgiving whether it will enter the marketplace.

A study newly published in Archives of Disease in Childhood sought to develop much-needed data specific to the treatment of pediatric inflammatory bowel disease with biosimilar infliximab, with a focus on safety and effectiveness.

The verdict against Hospira—who had not even sold its product in the United States, but was preparing to do so upon the 2015 and 2016 expiration of Amgen’s patents—is the most recent test of the “safe harbor” provision of the Patent Act that protects uses related to FDA approval.

An international panel of healthcare stakeholders recently released consensus recommendations for the use of biosimilars to treat rheumatologic diseases. Learn more about what the panel had to say.

After having warned that it could lose up to 94% of its staff in a relocation from its current home in London, United Kingdom, The European Medicines Agency (EMA) this week revealed its top location choices for the agency’s upcoming move.

A European study published this week finds that, at a minimum of 3.3 years after market entry, there was no conclusive evidence that many oncology drugs approved by the European Medicines Agency between 2009 and 2013 either extended or improved life in most oncology indications.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of October 2.

The Federal Trade Commission (FTC) has announced a November 8 workshop that will focus on competition issues related to prescription drug marketing.

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

Indication-based pricing is a method used to reimburse drug makers according to a drug’s indication-specific value when the drug has multiple indications. A number of healthcare payers have already implemented or are planning to implement IBP, including Express Scripts, the largest US pharmacy benefit manager.

A phase 3 study comparing Samsung Bioepis’ etanercept biosimilar, SB4, to its reference found that SB4 had comparable efficacy—including radiographic progression—to week 52 of treatment in patients with rheumatoid arthritis.

In addition to addressing the humanitarian toll that Hurricane Maria has taken on the residents of Puerto Rico, an additional, long-term challenge in coping with the storm’s aftermath is the potential for drug shortages.

A new study comparing the clinical effectiveness of anti–tumor necrosis factor agents and the interleukin-6 inhibitor tocilizumab (Acterma) in patients with rheumatoid arthritis found that tocilizumab outperformed anti-TNFs in terms of effectiveness and drug survival.

The number of people who had annual prescription medication costs of $50,000 or more in 2016 was 35% higher than it was in 2014, according to pharmacy benefit manager Express Scripts.

In the first week of October, FDA Commissioner Scott Gottlieb, MD, announced 2 new initiatives intended to make drugs more widely available: the first is designed to help developers of complex generics better navigate the approvals process, and the second aims to streamline access to investigational treatments for compassionate use.

The FDA’s Adverse Event Reporting System Public Dashboard, a new, user-friendly tool available to search the FDA’s adverse event database for drugs and biologics, has been launched.

Drug maker Shire has filed suit in a federal court in Newark, New Jersey, alleging that rival Allergan has violated antitrust laws in trying to preserve market share of its cyclosporine ophthalmic emulsion (Restasis) by blocking competition from Shire’s dry-eye drug, lifitegrast (Xiidra), on the Medicare Part D formulary.

While tumor necrosis factor (TNF) deficiency is associated with a higher incidence of tuberculosis, excessive production of TNF is associated with an exaggerated inflammatory response that can result in mycobacterial immune reconstitution inflammatory syndrome (IRIS).

A Brazilian study reports that adverse events occurred in approximately two thirds of patients with Crohn’s disease who were taking the anti-tumor necrosis factor medications infliximab and adalimumab.

If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.

Medicines for Europe says that the sustainability of healthcare budgets in European nations has been “intensely pressured” in recent years by factors including an aging population and the introduction of high-cost drugs, and that governments aiming to address those challenges have resorted to austerity measures that have “driven the prices of some off-patent medicines to unsustainably low levels."

Where does the market for infliximab stand in the United States? Our infographic provides a brief history of Remicade and its biosimilars.

Drug maker Amgen has announced a deal to partner with Simcere Pharmaceutical Group to co-develop and commercialize 4 biosimilar treatments in China.