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.

  • 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.

  • How This Employer-Driven Initiative Could Revolutionize Biosimilar Use
    How This Employer-Driven Initiative Could Revolutionize Biosimilar Use

    Using what The Coalition’s President and CEO Troy Ross has termed “3D thinking” through the creation of data mapping, employers are gaining access to information they’ve never been privy to before that will enable them to identify savings opportunities and better design their benefits — which could mean increased traction for biosimilars.

  • How Will Medicare’s International Pricing Index Model Affect Biosimilars?
    How Will Medicare’s International Pricing Index Model Affect Biosimilars?

    CMS has announced a new payment model that seeks to reduce out-of-pocket costs for patients. This payment model arises out of the Trump administration’s American Patients First Blueprint that was released earlier this spring. CMS is providing this notice of its proposed payment model via an Advance Notice of Proposed Rulemaking (ANPRM), meaning a formal proposed rule will be introduced in the near future. Comments close on this ANPRM on Dec. 31, 2018.

  • What Biosimilar Metamorphoses Are In Store For 2019?
    What Biosimilar Metamorphoses Are In Store For 2019?

    In the second of this three-part "Ask the Board" series, Biosimilar Development's editorial board members discuss their predictions on how biosimilar development, market access, commercialization efforts, and regulatory and reimbursement policies will evolve in 2019.

  • Top Trends In The Biopharmaceutical Industry And Bioprocessing For 2019
    Top Trends In The Biopharmaceutical Industry And Bioprocessing For 2019

    This article presents trends and findings from a survey and study of 222 responsible individuals at biopharmaceutical manufacturers and CMOs in 22 countries, as well as over 130 direct suppliers of materials, services, and equipment to this industry.

  • How Can The U.S. FDA, CMS, And HHS Help Biosimilars In 2019?
    How Can The U.S. FDA, CMS, And HHS Help Biosimilars In 2019?

    In the second part of this two-part article, I unpack how the FDA could solve one particularly challenging market barrier and why we should expect to see (and call for) more from other government agencies in 2019.

  • 2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?
    2018 Biosimilar Triumphs And Tribulations: How Have Market Expectations Evolved?

    In the first part of a three-part “Ask The Board” series, members of the editorial board share what left them feeling the most heartened or concerned in 2018 and what must take center stage as we head into 2019.

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

  • Improved Process Economics Of HUMIRA Biosimilar Purification

    Biosimilar purification costs constitute more than half of the total development costs. A significant number of these costs are due to the expense of Protein A–based media. 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.

  • Services Marketing: You Can’t Build A Strong Marketing Strategy On A Weak Foundation

    Too often, marketers lack vital information to create an effective marketing strategy and your organization and department suffer due to constant disruption of marketing plans. 

  • Dancing In The Bioprocessing Ballroom: Voices Of Experience

    Single-use technology is well-established and made its way into commercial licensed facilities, but there is more innovation in this field which will enhance its versatility into new markets and technologies.

  • Staying Flexible In Biomanufacturing

    The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment. Using a combination of financial options analysis and decision analytics to quantify your options helps to embrace the uncertainty equation.  

  • Keys To Consistent Bioprocessing

    The development of a robust and consistent bioprocess requires a systematic and risk-based approach to identify the right process parameters and raw materials.

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TRAINING COURSES

14th Annual Biosimilars Summit January 22 - 23, 2019
Alexandria, VA
Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
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
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

14th Annual Biosimilars Summit January 22 - 23, 2019
Alexandria, VA
Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
PAP 2019 March 5 - 6, 2019
Baltimore, MD

LIFE SCIENCE EVENTS

14th Annual Biosimilars Summit January 22 - 23, 2019
Alexandria, VA
Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
PAP 2019 March 5 - 6, 2019
Baltimore, MD
More Events...

LIFE SCIENCE INDUSTRY EVENTS

14th Annual Biosimilars Summit January 22 - 23, 2019
Alexandria, VA
Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
6th Annual Reimbursement and Contracting January 23 - 24, 2019
Philadelphia, PA
Patients Registries & Real World Evidence Summit January 30 - 31, 2019
Miami, FL
PAP 2019 March 5 - 6, 2019
Baltimore, MD
More Industry Events

ABOUT BIOSIMILAR DEVELOPMENT

Biosimilar Development is dedicated to presenting technical information, thought leadership, and commentary for the biosimilar development and manufacturing community. On this site, users will find exclusive and actionable content on the industry trends and challenges affecting the emerging biosimilars market. Browse our articles, case studies, and white papers on topics related to biosimilar development, manufacturing, quality, distribution, FDA guidance, BPCIA, global markets, government regulations, and intellectual property.

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