Allison Inserro

January 01, 2020

With drug costs continuing to spiral and slower uptake in the United States compared to other parts of the world, it is perhaps natural for observers of biosimilars to ask questions, not only about well-known patent issues, but about deeper issues, such as the way biosimilars are developed, the meaning of interchangeability, and perhaps the very structure of the industry itself. Here’s a look at 5 hot topics from 2019.

December 31, 2019

Cases involving adalimumab featured in 2 of the 5 top legal stories in 2019 that dealt with various legal matters, including charges of patent thicketing.

December 30, 2019

During 2019, The Center for Biosimilars® provided interviews and discussions with key opinion leaders on our podcast to discuss various issues affecting biosimilars. From patent issues to the arrival of oncology biosimilars, here is a look at our top 5 podcast episodes from 2019.

December 24, 2019

Clinical developments, policy news, and pharmaceutical business updates ranked among our most popular conference stories of 2019.

December 23, 2019

AstraZeneca and Daiichi Sankyo said Monday they received FDA approval for their [fam-] trastuzumab deruxtecan-nxki, which will be marketed as Enhertu. [Fam-] trastuzumab deruxtecan is an antibody–drug conjugate (ADC) designed to delivery cytotoxic chemotherapy to cancer cells via a human epidermal receptor 2 (HER2) antibody attached to a novel topoisomerase I inhibitor payload and a tetrapeptide-based linker.

December 20, 2019

Amgen and Allergan submitted a Biologics License Application (BLA) to the FDA for ABP 798, a biosimilar rituximab referencing Rituxan.

December 19, 2019

A federal appeals court Wednesday struck down the individual mandate—the heart of the Affordable Care Act (ACA) that requires everyone to have health coverage—and sent the case back to the federal district court in Texas to determine whether other parts of the law are constitutional and can exist without the mandate.

December 18, 2019

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.

December 16, 2019

Looking at products that entered the marketplace between 2015 and 2017, an FDA report finds that greater competition among generic drug makers is associated with lower prices.

December 13, 2019

Alberta became the most recent Canadian provincial government to mandate a nonmedical switch to biosimilars for certain patients on taxpayer-funded drug plans.