Biosimilar Regulatory solution center

  1. Medicare Negotiation And Competitive Licensing Act: An Ambitious Challenge To Biologic Patents

    In recent years there has been growing, bipartisan support to address the perceived high cost of biologic drugs. Indeed, recent estimates are that biologic drugs account for approximately 40 percent of all U.S. pharmaceutical sales and 70 percent of drug spending growth between 2010 and 2015.

  2. How Should We Really Feel About FDA’s Biosimilar Interchangeability Guidance?

    Reading through the two versions of the guidance, I had a few thoughts about some of these changes, which led me to reflect more broadly on their impact on the biosimilar regulatory and development sphere.

  3. 4 Takeaways From The FDA’s Insulin Hearing

    Overall, four talking points arose during the presentations that I felt were worthy of briefly singling out. Many of these points touch on the broader discussions happening in the biosimilar sphere, including tailored development, interchangeability, immunogenicity, device innovation, and overall patient and provider education.

  4. The China Biosimilars Market: Rise Of A Potential Powerhouse

    Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?

  5. Physicians And Biosimilar Uptake: How Do We Move Forward?

    Here, I’ll discuss some of the current physician knowledge gaps in the different therapeutic areas. Similarly, I’ll delve into the discussions surrounding what educational strategies and guidelines may be needed on the hospital or national level to improve physicians’ and patients’ relationships with biosimilars.

  6. 5 Intriguing U.S. Biosimilar Policy Questions

    Biosimilar Development recently hosted a webinar on U.S. biosimilar policies with Frier Levitt Government Affairs expert, Ron Lanton. Here are several questions that came up during the webinar about the impact proposed or current policies may have in the future.

  7. 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.

  8. 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.”

  9. 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.

  10. 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.