News

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.

Scott Gottlieb, MD, Commissioner of the FDA, has signaled that while biosimilars are on the rise, they need a boost from stakeholders if development of these therapies will continue to grow.

Ahead of next week’s proposed vote on Graham-Cassidy-Heller-Johnson, a Senate reconciliation bill that proposes to replace the Affordable Care Act with a system of state block grants given annually to help individuals pay for healthcare, insurers and providers groups are calling on Congress to reject the bill.

Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill 539.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 18, 2017.

In real-world community oncology settings, bevacizumab-containing regimens were associated with longer progression-free survival and overall survival compared with non-bevacizumab regimens.

Trends in data concerning publicly and privately insured patients with rheumatoid arthritis show that the use of bioloigic disease-modifying antirheumatic drugs (DMARDs) is on the rise.

The FDA has published its Biosimilar User Fee Act (BsUFA) rates for 2018. The Biosimilar User Fee Amendments of 2017 (BsUFA II) authorize the agency to assess and collect fees from applicants for biosimilar products from October 2017 to September 2022.

A recent study found that enrollment in patient support programs was associated with greater adherence, improved persistence, and reduced medical and total healthcare costs for patients who were receiving adalimumab therapy.

When a patient fails to respond or no longer responds to one biologic disease-modifying antirheumatic drug due to a lack of efficacy or poor tolerability, switching to another bDMARD can be a safe and effective treatment strategy.

Drug maker Pfizer announced today that it has filed a district court lawsuit in the Eastern District of Pennsylvania against Johnson and Johnson.

Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

In recent years, a wrench has been thrown into the patient care equation.

This Rheumatic Disease Awareness Month, Stanley Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at the University of Texas Southwestern Medical School, has a message for patients: biosimilar treatments are just as safe and effective as originator biologics in treating rheumatic diseases.

A retrospective case series suggests that low-level anti-tumor necrosis factor anti-drug antibodies in patients with inflammatory bowel disease may be overcome by dose escalation and/or addition of an immunomodulator, which can allow for clinical improvement in disease status.

Last week, CMS closed its comment period on the 2018 Revisions to Payment Policies under the Physician Fee Schedule. Multiple stakeholder groups within the biosimilars industry submitted comments to CMS with respect to its policy on biosimilar reimbursement.

Last week, England’s National Health Service released a commissioning framework for biological medicines, including biosimilars.

This month, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), trade groups representing the biopharmaceutical and biotechnology industries, announced that they are challenging Nevada’s Senate Bill (SB) 539 in district court litigation.