Biosimilar Regulatory solution center

  1. Can The FDA Salvage Interchangeable Follow-On Biologics?

    The Biologics Price Competition and Innovation Act (BPCIA) enacted in 2010 provides two abbreviated approval pathways for biological products (follow-on biologics). Developers of biologics can seek designation of their follow-on product as biosimilar to, or interchangeable with, a reference biological product approved by the Food and Drug Administration (FDA).

  2. EU5 Biosimilar Adoption: What Can The Past Tell Us About The Future?

    More than 13 years ago, Omnitrope (somatropin) received its approval in Europe on April 14, 2006. Since then, as of June 2019, 57 biosimilars from 15 different molecules have received greenlights, 27 of them in the last five years and 16 in the last year and a half. This acceleration is driven by the increasing need to generate savings that help keep pharmaceutical budgets under control. According to data from the consulting firm Fiercepharma, drugs approved in 2019 will generate sales of more than $20 billion in 2024.

  3. EMA Update: What Challenges Are Biosimilars Bringing To The Table?

    One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale, or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.

  4. Will Authorized Biologics Disrupt The Market For Biosimilars?

    Many of the doomsday scenario predictions for biosimilar competition if authorized biologics were to enter the space prematurely assume mainstream development and adoption of authorized biologics by innovator companies in the current market and do not take into consideration the outcomes seen over the past 18 years with authorized small molecule generics.

  5. WHO Elaborates Upon Biosimilar Prequalification Progress

    One technical expert from the WHO outlined the current requirements for the two pathways for biosimilar prequalification and the progresses and pitfalls for companies seeking a spot on the WHO’s list of prequalified medicines.

  6. Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes

    Once again, Congress has its eyes on the pharmaceutical industry. Legislators from both parties have been active in proposing new legislation that could impact biologics and the market for biosimilars in the United States. Although these proposed bills have taken a variety of approaches, they are principally focused on market access and pricing of biologic drugs.

  7. What Incentivized These Oncology Clinics To Embrace Biosimilars?

    I reached out to Dr. Jeffrey Patton, the CEO of Tennessee Oncology and president of physician services and board member at OneOncology to better understand the overall decision to implement Amgen's Kanjinti and Mvasi biosimilars, as well as which mechanisms he believes will help improve biosimilar usage in oncology in the months and years ahead.

  8. Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time

    In this second part of a two-part series, we’ll dive into some of the details and datasets behind pharmaceutical pricing, trends, and behaviors in an effort to move toward effective cost management, economic sustainability, and continued U.S. pharmaceutical innovation.

  9. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook

    At present, automatic substitution of biosimilars at a pharmacy level is not practiced in the EU5. Recent and future changes in the EU5 market access environment and regulatory landscape may favor automatic substitution, but implications on the biosimilar market are yet to be determined.

  10. FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

    While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.