FDA Releases Q&A for Industry With Details About Insulin TransitionMarch 5th 2020
Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.
Reference-Based Drug Pricing Shifts Mix of Therapies, Lowers Prices Paid, Study FindsFebruary 5th 2020
Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to a new study published Wednesday.
FDA, FTC Pledge Close Cooperation to Create Biosimilar CompetitionFebruary 4th 2020
The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.
Novo Nordisk Launches Authorized Generic Insulins, Gets FDA Approval for Fast-Acting Insulin in Pediatric PopulationJanuary 7th 2020
Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.
5 of the Biggest Controversies in Biosimilars in the Year 2019January 1st 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.
The Most Listened-to Podcast Episodes of 2019December 30th 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.
AstraZeneca, Daiichi Sankyo Win FDA Approval for Trastuzumab Antibody ConjugateDecember 23rd 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.
Federal Appeals Court Strikes Down ACA Individual Mandate, Sends Law Back to Lower CourtDecember 19th 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.
Do Biosimilars Have a Role in US Plan to Allow Imports?December 18th 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.