Biosimilar Regulatory solution center

  1. Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    2/11/2019

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

  2. What Is Skinny Labeling — And Will It Work For Biosimilars?
    2/5/2019

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

  3. 2019 CBI Biosimilars Summit: Sustainability Requires A Step-Wise Approach
    1/31/2019

    Just as the FDA emphasized that companies should take a “step-wise” approach to biosimilar development, I’d argue this same approach needs to be embraced in our commercialization and education efforts moving forward.

  4. The Evolving Landscape Of Medical Science Liaisons
    1/24/2019

    Though the report does not focus specifically on the role of MSLs in the biosimilar space, there were a few salient points to note for biosimilar companies as they consider the evolving roles and integration of these teams.

  5. How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    1/24/2019

     

    Sen. Bernie Sanders has introduced three bills aimed at reducing prescription drug prices, two of potential importance to biosimilar developers. This article discusses these cost-containment policies, as well as two other congressional initiatives to watch.

  6. Why This Biosimilar Initiative Is One To Watch In 2019
    1/16/2019

    When news came my way in early December that the Biosimilars Forum had established the Biosimilars Roundtable, which would be a working group comprising members of 40 different stakeholder organizations, I was thrilled.

  7. What RWE Questions, Trends Must Biosimilars Embrace In 2019?
    1/8/2019

    In this article, I share the (very) few examples of real-world evidence I found in 2018 that served as outliers compared to all the positive biosimilar data. I’ll also explore the ways RWE being released today is evolving beyond the single switching studies we’ve grown accustomed to in the past two years.

  8. Biosimilar “Fake Views” Roundup
    1/4/2019

    The end goal of this creative biosimilar-related work of fiction is to reflect upon and make light of the most prominent market hurdles we’ve faced thus far in the biosimilar industry.

  9. Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges
    1/3/2019

    As we enter 2019, editorial board experts share their thoughts on what challenges will be top-of-mind for biosimilar companies, trade groups, and payers, as we progress into the new year.

  10. Top 5 Biosimilar Developments Of 2018
    12/28/2018

    As the industry matures, I’m finding it harder and harder to single out one specific news headline as being the most influential. Rather, each of these Top 5 encompasses a series of events that, together, have further defined and carried this industry forward.