Biosimilar Regulatory solution center

  1. How The Purple Book Continuity Act Could Challenge Biosimilars & The FDA

    On March 5, 2019, Representative Anna Eshoo (D-CA) introduced H.R. 1520, the “Purple Book Continuity Act of 2019.” The bill addresses the availability of information about approved biological products that may support the development of biosimilar products. It has five cosponsors in the House, drawn from both sides of the aisle, and was considered with five other bills by the House Energy and Commerce Committee on April 3, 2019. The Committee advanced the bill, along with five others, as a step toward addressing runaway drug pricing.

  2. HHS Safe Harbor Rebate Proposal: Biosimilars' New Hope?

    On Feb. 6, 2019 the Department of Health and Human Services (HHS) officially proposed the rebate rule known as the “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees.”

  3. 3 Tips To Advance Biosimilar Education For IBD Patients

    Whether it be pointing out specific unmet needs in IBD or suggesting meaningful educational materials for patients, one patient advocate delivered great examples of how manufacturers can support patient advocates and provide them with the information they need most today.

  4. How Advocacy Groups, Biosimilar Makers Can Improve Biologics Education For Physicians

    In this first of two articles, an advocate from the Crohn's and Colitis Foundation shares details about the Foundation’s ongoing initiatives in terms of educating physicians, as well as what can be done to better understand and improve physicians’ biologics and biosimilar prescribing practices.    

  5. Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End

    Within the last few years, the FDA has taken steps to approve more biosimilar products and has committed to providing for a competitive landscape. The three latest biosimilars to be approved by the FDA have all been biosimilars to Herceptin. Further, Pfizer’s Trazimera, the most recently approved trastuzumab biosimilar, has sparked intrigue. As a result, Genentech is bracing for Herceptin biosimilar commercial launches in 2019.

  6. How Will USPTO Guidance Revisions Impact Biosimilars?

    Since 2012, patent stakeholders in the U.S. have faced remarkable uncertainty in the evaluation of patent subject matter eligibility under 35 U.S.C. 101, particularly in the application of the Supreme Court’s Alice/Mayo1 test by the United States Patent and Trademark Office (USPTO). 

  7. Biosimilars Vs. Interchangeable Biologics: Which Is A Distraction?

    I found myself puzzled, to say the least, by a recent editorial intriguingly entitled “Biosimilars Are A Distraction.” What I ended up reading were several questionable economic and clinical claims I feel are worth dissecting. 

  8. 3 Crucial Discussions From The Biosimilar Medicines Conference

    After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.

  9. Biosimilars In The Hospital Market, Then And Now: Addressing The Challenges

    About 12 years ago, while working at a group purchasing organization (GPO), I had my first conversations with pharma/biotech companies about the possibility of developing and launching biosimilar drugs. Part of my role at the GPO was related to tracking and commenting on policies CMS and the FDA were developing.

  10. What’s In A Name? FDA Proposes Updates To Its Biosimilar Naming Policy

    The U.S. FDA issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update. This update is the FDA’s second attempt at a policy for nonproprietary name suffixes for biologic products.