Regulatory

Baltimore, Maryland, Sues Both AbbVie and Amgen Over Humira

April 2nd 2019

By Kelly Davio

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.

Daiichi Sankyo to Accelerate BLA Submission for DS-8201

April 1st 2019

By Kelly Davio

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.

Biosimilar Regulatory Roundup: March 2019

March 29th 2019

By Allison Inserro

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 In addition, the FDA released updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars; approved a Pfizer biosimilar; and more.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 Top 5 Biosimilars Articles for the Week of March 25

March 29th 2019

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

Fostering Biosimilar Policies for a Sustainable Future

March 28th 2019

By Kelly Davio

While Europe may be one regulatory jurisdiction, covered by the European Medicines Agency, each European nation must forge its own path in encouraging biosimilar adoption and competition. During the opening day of the Medicines for Europe 17th Biosimilar Medicines Conference, held March 28-29 in Amsterdam, the Netherlands, a variety of stakeholders addressed how their respective countries are addressing the need for policies to encourage biosimilars.

Experience With Basaglar Shows How Biosimilars Can Save on Insulin Costs, Research Letter Says

March 27th 2019

By Kelly Davio

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.

Eye on Pharma: Withdrawn BLA for Novel G-CSF Expected to Compete With Pegfilgrastim

March 27th 2019

By The Center for Biosimilars Staff

Spectrum Pharmaceuticals has withdrawn its Biologics License Application (BLA) for eflapegrastim, a granulocyte colony-stimulating factor (G-CSF) therapy that the company had hoped to sell under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

Lupin and YL Biologics Receive Japanese Approval for Etanercept Biosimilar

March 26th 2019

By The Center for Biosimilars Staff

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.

Citizen Petition Asks FDA to Withdraw Contentious Biologic Naming Guidance

March 26th 2019

By Kelly Davio

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.

"Not So Different:" Addressing Misinformation on Biosimilars

March 24th 2019

Last year, biosimilar developer Pfizer submitted a citizen petition to the FDA in which it called on the agency to issue guidance clarifying how drug sponsors can communicate about biosimilars. After the petition was filed, The Center for Biosimilars® invited an expert group of stakeholders to discuss misinformation about biosimilars as well as what steps are necessary to root out and address the misinformation.