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    • 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 As a follow-up to its 2017 Guidance for Industry: Nonproprietary Naming of Biological Products, FDA issued a new draft guidance filling …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 …

    • Is Fairness in the Eye of the Beholder? Pfizer Citizen Petition Looking for Fair and Level Playing Field Between Biologics and BiosimilarsAugust 29th, 2018

      An interesting Citizen Petition popped up earlier this week in which pharma giant Pfizer has requested FDA guidance on sponsor communications about biosimilar products.  This is not a new campaign for Pfizer, who has emphasized the need to address anticompetitive exclusionary practices, “misinformation,” and market …

    • House and Senate Bills Would Require Reporting of Biosimilar Agreements to the DoJ and FTCAugust 20th, 2018

      Last month, Representatives John Sarbanes (D-MD) and Bill Johnson (R-OH) introduced H.R. 6478, the “Biosimilars Competition Act of 2018.”  The bill would amend the Public Health Service Act (“PHS Act”) to require that certain agreements between biosimilar applicants and reference product sponsors be reported to …

    • FDA’s Exploration of Innovation vs. Access Continues with Public Hearing on the Biosimilar MarketplaceJuly 26th, 2018

      Just like last year when it held a public hearing and rolled out the Generic Drug Action Plan, FDA is following its recent announcement of the Biosimilar Action Plan with a Public Hearing on competition in the biologics market entitled Facilitating Competition and Innovation in …

    • Biosimilar Action Plan Introduced to Kick-Start the Biosimilar MarketJuly 20th, 2018

      Though the pace of biosimilar approval has quickened substantially over the last year (with 6 approvals since this time last year alone), the biosimilar market remains sparse and slow. Unsurprisingly, FDA has noticed.  This week, FDA unveiled a Biosimilars Action Plan (BAP) aimed at speeding …

    • Maine Law Aims to Increase Generic Drug Developers’ Access to Reference SamplesJuly 17th, 2018

      By Michelle L. Butler & Eliot Markman* – On July 4, 2018, 2017 ME S 432, titled “An Act To Require Drug Manufacturers To Comply with Federal Law” (the “Act”), became law without Maine Governor Paul LePage’s signature.  The Act amends 32 M.R.S.A. § 13702-A and …

    • Biosimilar Approval: Better, Stronger, FasterMay 21st, 2018

      We have the technology. It will definitely cost more than six million dollars, and there are questions about whether it will be better than it was before.  But Dr. Sarfaraz Niazi thinks he can rebuild the biosimilar approval process to make it more efficient. In an …

    • FDLI’s Introduction to U.S. Biologics and Biosimilars Law and RegulationSeptember 28th, 2017

      Hyman, Phelps & McNamara, P.C.’s Mark I. Schwartz will be presenting on the Regulation of Biological Manufacturing at the Food and Drug Law Institute's (“FDLI’s”) Introduction to U.S. Biologics and Biosimilars Law and Regulation course, which is scheduled to take place from October 4-5, 2017 in Washington, …

    • FDA’s Approach to Analytical Similarity for Proposed BiosimilarsSeptember 27th, 2017

      Earlier this week, FDA published another in its series of guidance documents devoted to implementing the Biologics Price Competition and Innovation Act (“BPCIA”). The objective of the new guidance, entitled Statistical Approaches to Evaluate Analytical Similarity Guidance for Industry, is to assist sponsors in demonstrating …