Biosimilar Regulatory solution center

51. EMA Update: What Challenges Are Biosimilars Bringing To The Table? 11/8/2019

    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.

52. Will Authorized Biologics Disrupt The Market For Biosimilars? 11/5/2019

    The small molecule generic drug market and the current biologics/biosimilar market are ultimately not directly comparable. However, it's instructive to analyze how authorized generics impact the small molecule space to predict how authorized biologics may impact the biosimilar/interchangeable market in the future.

53. WHO Elaborates Upon Biosimilar Prequalification Progress 10/31/2019

    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.

54. Legislation To Watch: 9 Proposed Bills Impacting Biologics & Patent Disputes 10/29/2019

    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.

55. What Incentivized These Oncology Clinics To Embrace Biosimilars? 10/23/2019

    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.

56. Biologics Pricing: A Deep-Dive Into Dynamics And Behaviors Over Time 10/22/2019

    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.

57. Biosimilar Automatic Substitution In The EU5: Current State & Future Outlook 10/8/2019

    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.

58. FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics 9/30/2019

    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.

59. A Delicate Balance: Patent Exclusivity, Innovation, And Competition 9/27/2019

    Overall, arguments calling into question the value of biologics competition tie into what I think is an even more important question worth asking in this country: What global responsibility does the U.S., as the largest pharmaceutical market, have in terms of promoting greater access to medicines?

60. Do The Arguments For Pharmaceutical Price Increases Make Sense? 9/24/2019

    This article will share recent analysis of price increases within the healthcare sector in an effort to understand the growth of healthcare expenditures and pharmaceutical prices over time.