News

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.

The standard way to conduct mobilization in hematopoietic stem cell donors relies on using 2 original granulocyte-colony stimulating factors (G-CSFs), filgrastim (Neupogen) and lenograstim (Granocyte).

September was a busy month for oncology biosimilars: the first anticancer biosimilar was approved in the US, new data showed promising momentum for additional therapies, and patent litigation yielded costly results for one biosimilar developer.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 25, 2017.

The California legislature has passed SB 17, a major effort to ensure transparency in drug pricing.

A study by Cristina Scavone, MS, and colleagues, published in Frontiers in Pharmacology, concludes that most biologic drugs used to treat cancer, rheumatoid arthritis, and psoriatic arthritis in real-world clinical settings demonstrate overall good tolerability

Drug maker Amgen announced today that it has reached a global settlement with AbbVie, developer of reference adalimumab (Humira), over Amgen’s biosimilar adalimumab, Amgevita.

The European Medicines Agency released results of an internal survey that asked staff to which proposed cities they would consider relocating. The lowest-ranking city was one to which only 6% of respondents were likely or very likely to relocate.

A study of Japanese patients with ulcerative colitis who were naïve to anti–tumor necrosis factor treatment found that patients preferred adalimumab to infliximab, but the researchers also reported no differences in the efficacy of the 2 treatments.

Republican efforts to repeal and replace the Affordable Care Act may have stalled once again with the failure of the Graham-Cassidy bill on Thursday, but advocacy groups intend to keep healthcare—and the high cost of prescription drugs—at the forefront of Congress’ agenda.

Amgen has filed a news Biologics Price Competition and Innovation Act (BPCIA) suit against rival drug maker Mylan.

Republicans have cancelled plans to vote on the latest legislative effort to repeal and replace the Affordable Care Act after 3 members of the party announced that they would vote “no” on the Graham-Cassidy bill.

Biosimilar developer Hospira has been ordered to pay Amgen $70 million after a jury found that the drug maker infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin.

A large Canadian study of patients with inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, reports that a high overall rate of adherence to subcutaneous anti-TNFs.

Healthcare company Fresenius Kabi has initiated a $250 million expansion of its Illinois manufacturing location and acquired Merck KGaA's biosimilars business.

The rituximab biosimilar CT-P10 (Celltrion and Teva’s Truxima), which is approved in the European Union and under review by the FDA in the United States, showed comparable effectiveness to reference rituximab (Genentech and Biogen’s innovator product, sold as Mabthera and Rituxan) in a network meta-analysis.

The FDA has issued a complete response letter (CRL) for Johnson and Johnson’s proposed rheumatoid arthritis (RA) drug, sirukumab. Janssen Biotech, a division of Johnson and Johnson, had filed a Biologics License Application (BLA) for the interleukin-6 (IL-6) inhibitor, including data from a global phase 3 clinical development program, in September 2016.

At the 26th Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, Sandoz announced positive data from a phase 3 confirmatory study to compare the efficacy and safety of Sandoz’s proposed biosimilar adalimumab, GP2017, with its reference.

The FDA has approved, to date, 7 biosimilar treatments.