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  • Biosimilars

    • The Code is Cracked: Interchangeable Biologics are HereAugust 13th, 2021

      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 …

    • Biden “Promoting Competition” Executive Order Falls In Behind Drug ImportationJuly 12th, 2021

      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 …

    • The More You Know: FDA Provides Additional Guidance on BiosimilarsDecember 16th, 2020

      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) …

    • Not So Smooth of a “Transition”: FDA Sued Over Deemed BLA Transitions – or Lack ThereofApril 28th, 2020

      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 …

    • Makin’ It: How Does the Safe Harbor Apply to Biosimilar Manufacturing?March 18th, 2020

      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 …

    • Knives Out: Carving Up an aBLAFebruary 12th, 2020

      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 …

    • HP&M’s Sara Koblitz to Present on FDA Updates on Biologics and BiosimilarsFebruary 7th, 2020

      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 …

    • FDA and FTC Announce New Steps Under the Biosimilars Action Plan, Which Include Targeting False and Misleading Statements About BiosimilarsFebruary 5th, 2020

      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 …

    • Hot Sticky Sweet: FDA Provides Advice on Biosimilar Applications for InsulinDecember 5th, 2019

      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 …

    • FDA Law Alert: Issue #2August 7th, 2019

      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 …

    • Anything You Can Do I Can Do (Better?): Demonstrating Biosimilar InterchangeabilityMay 16th, 2019

      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 …

    • And if They Don’t Dance, Well They’re No Friends of Mine – And They’ll Probably Get SuedMay 8th, 2019

      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 …

    • Let’s Play Name That Biosimilar!March 12th, 2019

      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 …

    • Avalanche or Roadblock: FDA Publishes Flurries of Biologic and Biosimilar MaterialsJanuary 3rd, 2019

      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 …

    • FDA and the FTC Won’t Get Fooled AgainOctober 24th, 2018

      Last week, the President signed into law a bill that gives the FTC greater authority to police agreements between biologic license holders and biosimilar applicants – so-called “pay-for-delay” settlements.  The FTC has been focused on these settlements in the pharmaceutical space for years, but until now …