News

The study is an open-label extension of a phase 3 trial that included 68 weeks of treatment with the biosimilar adalimumab, Amjevita, followed by an assessment visit at week 70 and an end-of-study visit at week 72.

Intravenous golimumab and infliximab are both widely used in the treatment of rheumatoid arthritis (RA) in the United States, though these anti–tumor necrosis factor agents have markedly different dosing recommendations; patients who receive golimumab may receive 7 infusions during year 1, while patients who receive infliximab may receive between 8 and 14 infusions during year 1.

Biosana Pty Ltd, a subsidiary of BiosanaPharma BV, says it received permission from the Australian Bellberry Human Research Ethics Committee (HREC) to start a phase 1 trial for a biosimilar version of omalizumab.

The FDA this week finalized a 2016 draft guidance that explains when the agency deems a Risk Evaluation and Mitigation Strategy (REMS) program to be necessary for a given drug.

The Center for Biosimilars® recaps the top news for the week of April 1, 2019.

In December 2018, the FDA announced its guidance for industry on the interpretation of the “Deemed to be a License” provision in section 7002(e) of the Biologics Price Competition and Innovation Act. The bill introduced this week would codify those guidelines, as they pertain to insulin, into law to prevent any future administrations from revoking them.

Next week, researchers from around the globe will gather in Geneva, Switzerland, for the 2019 European Lung Cancer Congress. During the meeting, multiple research teams will discuss new findings from research into the use of bevacizumab—which now has approved biosimilars that promise cost savings and expanded patient access—in nonsquamous non–small-cell lung cancer (NSCLC).

Korean drug maker Celltrion announced that it has completed enrollment in its phase 3 clinical trial of CT-P17.

As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.

Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.

Sandoz announced today that it has resubmitted to the FDA its Biologics License Application (BLA) for its proposed biosimilar pegfilgrastim.

Stakeholders testified before a House of Representatives subcommittee about the impact of the rising costs of insulin, while the FDA announced it will hold a public hearing May 13 about its plan to transition follow-on insulins to a regulatory pathway for biosimilars.

A new consensus report calls the nocebo effect underrecognized in the area of biosimilars and says that more research is needed on this important topic.

Yet another class action lawsuit has been filed against AbbVie, maker of the brand-name adalimumab, Humira. The latest suit, brought by the mayor and city council of Baltimore, Maryland, on behalf of themselves and others similarly situated, alleges that, absent AbbVie’s conduct, biosimilar adalimumab could have been available in the United States as early as 2016. It also alleges that biosimilar developer Amgen was paid by AbbVie to delay its marketing of a biosimilar adalimumab.

While policymakers are grappling with ways to reduce to cost of expensive prescription drugs, one of the proposed solutions—targeting rebates negotiated by pharmacy benefit managers (PBMs)—will not on its own be enough to reduce overall pharmaceutical spending, according to a new brief from The Commonwealth Fund.

Approval of biosimilars in indications for which they were not studied directly in phase 3 clinical trials relies on the extrapolation of indications, a concept that is scientifically justified but, nevertheless, has generated some concerns among clinicians. In the case of biosimilar infliximab CT-P13 (Inflectra, Remsima), some gastroenterologists have voiced a lack of confidence in the biosimilar for the treatment of inflammatory bowel disease, including Crohn disease (CD) and ulcerative colitis. Now, head-to-head study, published in The Lancet, has produced data that may help allay those worries.

Daiichi Sankyo has announced that it is accelerating its Biologics License Application (BLA) for DS-8201, [fam-] trastuzumab deruxtecan for the treatment of patients who previously received ado-trastuzumab emtansine (Kadcyla), to the first half of 2019.

Pfizer’s biosimilar filgrastim, Nivestym, was approved by the FDA in July 2018 and launched in the United States in October 2018. Among the data on which the approval was based were 3 comparative clinical assessments of the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of the biosimilar versus the US-licensed reference filgrastim (Neupogen) in both male and female healthy volunteers. Results from these studies were reported in full last week.

March 2019 kicked off with a surprise, when FDA Commissioner Scott Gottlieb, MD, announced he was leaving the administration. In addition, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars; approved a Pfizer biosimilar; and more.

The Center for Biosimilars® recaps the top news for the week of March 25, 2019.

The presentation at the National Comprehensive Cancer Network reviewed regulatory requirements and updates in the 2019 guidelines that affected biosimilars.

March has been a rollercoaster month for the healthcare industry. From the sudden resignation of FDA Commissioner Scott Gottlieb, MD, to the announcement of the FDA’s current thinking on nonproprietary names of biological products, I have been hearing many questions from stakeholders on what, exactly, is happening with biosimilars. Let’s take a quick look at the FDA’s latest guidance on naming and at where the FDA is headed with new leadership.

The House Ways and Means Subcommittee on Trade heard testimony this week from labor leaders and others about a revised trade agreement that some say will hurt the biosimilar industry in the United States.

This week, a research letter published in JAMA gives some insight into how biosimilars of long-acting insulins could impact the cost of insulin therapy for patients with diabetes.

Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under the brand name Rolontis.

The Affordable Care Act was signed into law 9 years ago and created a biosimilars market in the United States, but what could happen if the Trump administration is successful in persuading the Fifth Circuit Court of Appeals to affirm a lower court ruling that the law is invalid?

Lupin and YL Biologics announced today that they have received approval to manufacture and sell YLB113, a biosimilar etanercept product, in Japan. The product will be Lupin’s first biosimilar to come to the Japanese market.

The FDA's updated guidance on the naming of biologics, biosimilars, and interchangeable products has caused deep concern among some proponents of biosimilars, and one stakeholder has now filed a citizen petition with the FDA in which he asks that the guidance be withdrawn.

Roche Holding AG has reached a confidential US patent settlement with Pfizer regarding its brand-name rituximab (Rituxan).

Recently, a study sought to determine whether dose reductions of anti–tumor necrosis factor (anti-TNF) therapies are possible for long-term treatment of spondyloarthritis, and found that a reduced dose is noninferior to a full dose in patients in sustained clinical remission.