There’s a lot of things packed (and that need to be unpacked to understand) into the latest version (as amended) of H.R. 5376, the 2100-plus page bill better known as the “Build Back Better Act.” The bill has gone through the House Committee on Rules …
About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar. On July 30, 2021, FDA approved Semglee (insulin glargine-yfgn), an insulin product that relies on Lantus (insulin glargine) as …
On Friday, President Biden issued a wide ranging Executive Order seeking to address overconcentration, monopolization, and unfair competition in the U.S. economy. Using an aptly named “whole-of-government” approach, the Order calls on the Department of Justice, the Federal Trade Commission, the Agriculture Department, the Treasury …
Biosimilars have been around for a bit over 10 years now, and there has been tremendous progress in licensing new biosimilar products. But there is no question that there are still significant holes that FDA must address to further facilitate biosimilar development under section 351(k) …
We’re a little late to the party on this one (let’s just blame it on social distancing), but, after 10 years in the making, Transition Day has finally come and gone for protein products. For the uninitiated, on March 23, 2020, all products approved as …
With the growth of biosimilar applications, courts have been faced with a litany of questions arising from the interplay between reference product intellectual property and the biosimilar application process. Though the BPCIA was designed to “learn” from FDA’s experience with the Hatch-Waxman Act, the procedural …
As more biosimilars are approved (we’re up to 26 now!), FDA has been rolling out guidance documents under the Biosimilars Action Plan (“BAP”). The most recent guidance has been long awaited. While the Hatch-Waxman Act explicitly provides that an applicant can seek approval for only …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sara Koblitz will be speaking in an upcoming Strafford live webinar, “Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation” scheduled for Thursday, February 13, 1:00pm-2:30pm EST. The panel will provide …
On February 3rd, FDA announced several new actions as part of its Biosimilars Action Plan (BAP). If you recall, back in July 2018 when FDA first unveiled the BAP, four key elements were identified: improving efficiency of biosimilar and interchangeable product development; maximizing scientific and …
As we move in to 2020, FDA is fastidiously preparing for the event 10 years in the making: the transition. For those of you unfamiliar with the “transition,” it refers to the “deemed to be a license” provision of the Biologics Price Competition and Innovation …
Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …
FDA recently finalized its guidance document intended to assist protein biosimilar manufacturers in demonstrating interchangeability, Considerations in Demonstrating Interchangeability With a Reference Product. Interchangeability, as of now, is nothing more than a pipe dream; no biosimilar has been declared interchangeable and therefore fully substitutable for …
As FDA continues to approve biosimilar drug products, and as sponsors participate – or rather choose not to participate – in the Biologics Price Competition and Innovation Act (“BPCIA”) version of the patent dance, more questions arise about the remedies reference product sponsors have when …
Ok, Tom, I think I can name that biosimilar in four letters! Added on to the suffix! And let’s make it interesting: it’s an interchangeable. As a follow-up to its 2017 Guidance for Industry: Nonproprietary Naming of Biological Products, FDA issued a new draft guidance filling …
At the end of a calendar year in DC, we expect to see a few flurries. Maybe some light snow, but definitely flurries of regulatory activity. December is often rich with FDA publications, specifically warning letters and guidance documents. And things have not changed this …
