Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

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.

  • The Evolving Landscape Of Medical Science Liaisons
    The Evolving Landscape Of Medical Science Liaisons

    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.

  • How Would Proposed Congressional Price Control Policies Impact Biosimilars?
    How Would Proposed Congressional Price Control Policies Impact Biosimilars?

     

    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.

  • Why This Biosimilar Initiative Is One To Watch In 2019
    Why This Biosimilar Initiative Is One To Watch In 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.

  • FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health
    FDA Shutdown: Assessing The Potential Impact On Innovation And Public Health

    I am not an expert on immigration or building walls. I don’t pretend that I can totally understand the political strategy of either party at the high level of the government shutdown. But as someone very familiar with the FDA, I am growing increasingly concerned that the longer the government shutdown continues — dragging the FDA along with it — the greater the potential for harm to the public health.

  • What RWE Questions, Trends Must Biosimilars Embrace In 2019?
    What RWE Questions, Trends Must Biosimilars Embrace In 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.

  • Biosimilar “Fake Views” Roundup
    Biosimilar “Fake Views” Roundup

    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.

  • Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges
    Biosimilar Experts Pinpoint 2019’s Biggest Industry Challenges

    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.

  • Top 5 Biosimilar Developments Of 2018
    Top 5 Biosimilar Developments Of 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.

  • Why 2018 Was The Year Of Real-World Evidence
    Why 2018 Was The Year Of Real-World Evidence

    In the first of what will be two articles on this topic, I unpack some of the most impactful real-world evidence releases or efforts implemented over the past year, as well as which of the biggest biosimilar questions were answered over the past year.

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

  • Optimizing Process Efficiency In Upstream Manufacturing

    Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency - a key goal for biopharmaceutical production.

  • Chasing The Biopharma Market

    From new customer bases and vaccines to biosimilars and antibodies: what are the emerging trends and hot topics in biopharma, and how can companies take advantage of them in order to succeed?

  • Speed Biologics To Clinical Trials Faster

    If your business strategy doesn’t fully align with your organization’s capabilities in terms of expertise, capacity, and resources, it might be wise to consider outsourcing to a biologics CDMO for speed to market.

  • How Services Marketers Can Own Their Performance Measures

    Service marketers can take control of their marketing performance by implementing credible marketing effectiveness measures and creating their own narrative.

  • Improved Process Economics Of HUMIRA Biosimilar Purification

    This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.

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TRAINING COURSES

PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
3rd Annual Biosimilars and Biologics March 21 - 22, 2019
Porto
15th Annual Pharma Forum 2019 March 24 - 27, 2019
New York, NY
17th Biosimilar Medicines Conference March 28 - 29, 2019
Amsterdam
20th Annual Computer and IT Systems Validation April 23 - 25, 2019
San Diego, CA
6th Annual FMV Congress May 1 - 2, 2019
Philadelphia, PA
5th Annual Endpoint Adjucation May 1 - 2, 2019
Philadelphia, PA
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
3rd Annual Biosimilars and Biologics March 21 - 22, 2019
Porto

LIFE SCIENCE EVENTS

PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
3rd Annual Biosimilars and Biologics March 21 - 22, 2019
Porto
More Events...

LIFE SCIENCE INDUSTRY EVENTS

PAP 2019 March 5 - 6, 2019
Baltimore, MD
IVT's Statistics in Validation March 6 - 7, 2019
Philadelphia, PA
Medical Device Validation Week March 12 - 14, 2019
Minneapolis, MN
Life Sciences Accounting and Reporting Congress March 20 - 22, 2019
Philadelphia, PA
3rd Annual Biosimilars and Biologics March 21 - 22, 2019
Porto
More Industry Events

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