When The Goal Is To Be (Bio)similar, What Does Differentiation Mean?
When The Goal Is To Be (Bio)similar, What Does Differentiation Mean?

As concerns about the cost of medicines reach a fever pitch, innovators are looking to leverage a promising advancement to help address the fundamental need for sustainable healthcare in the U.S. — biosimilars.

  • How Interested Is The FDA In Real-World Evidence?
    How Interested Is The FDA In Real-World Evidence?

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry.

  • Why Pharma Needs A New Approach To Patient Engagement In Drug Development
    Why Pharma Needs A New Approach To Patient Engagement In Drug Development

    Pharmaceutical companies face many challenges: developing life-changing products that meet the needs of patients, physicians, and payers; adhering to regulatory standards; and managing health technology and payer scrutiny, all while trying to satisfy investors. As drug prices seem to be continually rising, many health plans are shifting more of the cost-sharing burden to patients.  As a result, the patient is becoming more of a “consumer” in the traditional sense.

  • Beyond IP Protection: New Tactics Blocking Generic/Biosimilar Market Access
    Beyond IP Protection: New Tactics Blocking Generic/Biosimilar Market Access

    There is perpetual tension between competition and exclusivity.  Competition supports multisource supply.  Exclusivity requires protection for a single source.  Both have bearing on access to medicines.  

  • What These Two Mottos Must Mean For The Biosimilar Industry
    What These Two Mottos Must Mean For The Biosimilar Industry

    I recently attended the Association for Accessible Medicines (AAM) Biosimilars Council’s Leading on Biosimilars conference.In addition to the many tidbits of knowledge I took away from this event, two terms kept resurfacing throughout the conference I feel are worth delving into more deeply.

  • Integrated Delivery Networks & The Future Of Drug Development
    Integrated Delivery Networks & The Future Of Drug Development

    IDN characteristics can include shared clinical guidelines, a common technology platform, and the ability to jointly negotiate with payers on contracts that may involve financial risk for quality and patient outcomes. Simply put, IDNs are healthcare ecosystems unto themselves. 

  • Real-World Evidence & The 21st Century Cures Act — What You Need To Know
    Real-World Evidence & The 21st Century Cures Act — What You Need To Know

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market  — in other words, to “the real world.”

  • Why You Should Care About Real-World Evidence (A Lot)
    Why You Should Care About Real-World Evidence (A Lot)

    When the Clinical Leader team attended the 2017 DIA Annual Meeting in June, the topic we heard discussed more than any other was real-world evidence (RWE) — that is, information about a drug that is collected outside of clinical trials. RWE is not a new concept, but there are good reasons for all the current attention being paid to it in the pharma industry. For one, the 21st Century Cures Act, enacted into law in December 2016, seeks to speed the FDA drug and medical device approval processes by shifting some of the evidentiary requirements, in certain instances, from clinical trials to post-market  — in other words, to “the real world.”

  • Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future
    Pfenex’s New CEO Sizes Up Biosimilar Industry’s Future

    Newly-appointed Pfenex CEO, Eef Schimmelpennink, faces the challenge of determining how to adapt Pfenex to a constantly changing future. Though it's still very early in his tenure, Schimmelpennink highlights some areas he will keep in mind as he steers Pfenex's future biosimilars onto the market.  

  • Can New York City Lead In Life Sciences?
    Can New York City Lead In Life Sciences?

    New York City has long aspired to become a life sciences hub, but while the city seems to have all the elements necessary to foster such industry growth, it has continually fallen short of this goal. 

More Biosimilar editorial...

BIOSIMILAR INSIGHTS

  • Extractables Studies For Single Use Systems Used In ADC Manufacturing

    Studies performed on disposable chromatography column housings and disposable flow paths address the concerns of potential leachables from the plastic and elastomeric materials of single-use components.

  • Cross Flow Filtration Method Handbook

    This handbook gives a general introduction to the principles and applications of cross flow filtration using systems and filters from GE.

  • Optimizing the Flexural Strength of Bioprocess Film

    This poster focuses on how the resin selection and architecture of a bioprocess film can be optimized to maintain critical performance attributes, such as container integrity and gas barrier properties, under the significant forces during bulk liquid transportation and WAVE Bioreactor™ system applications.

  • The Extreme Costs Of A Bioburden Incident - Infographic

    Apart from the potentially tragic impact on patients, the economic consequences of a batch failure are enormous. For the mAb blockbusters, a month production stop can result in lost revenues of up to 1 billion dollars and a typical QA investigation could cost $20,000.  Thankfully, there are solutions for decreasing the risks.  Download this Infographic on the financial impact of a bioburden incident and ways to reduce said impact.

  • Insights And Tips When Addressing Bioburden Challenges

    This white paper addresses the challenges associated with the bioburden control process involved in making mAbs or other biologicals, as well as the single-use solutions and improved ways of working that manufacturers can use to avoid microbial contamination.

More From Biosimilar...

TRAINING COURSES

Best Practices in CMC Dossier Preparation – Facing Tough Challenges October 19, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Biosimilars Conference October 24 - 25, 2017
Bethesda,, MD
CRO Oversight Post ICH GCP E6 (R2) Addendum October 25, 2017
Live Date TBD
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Diogo Ribeiro October 26 - 27, 2017
Porto
Pharma Water Systems – Commissioning and Qualification to Ensure Compliance November 2, 2017
1:00 PM - 2:30 PM EDT
Duration:  90 Minutes
Price:  $299 – Includes Bonus handouts
Data Integrity: Why Not Identifying Repeat Defects In Your Data Is Killing Your Performance November 6, 2017
1:00 PM - 2:00 PM EDT
Duration:  60 Minutes
Price:  $299 – Includes Bonus handouts
Laboratory Data Integrity: Current Expectations for OOS Result Investigations November 15, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
4th Annual Biosimilars North America November 15 - 16, 2017
Iselin, NJ
Price:  $300 Early Bird ending on June 30, 2017
13th Biosimilars Summit January 23 - 24, 2018
Alexandria, VA
More Upcoming Courses
Anna Rose Welch article header

 EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges October 19, 2017
1pm-2:30pm EDT, Online Training
Price:  $299 - Includes Bonus Handouts!
Biosimilars Conference October 24 - 25, 2017
Bethesda,, MD
CRO Oversight Post ICH GCP E6 (R2) Addendum October 25, 2017
Live Date TBD
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Diogo Ribeiro October 26 - 27, 2017
Porto

LIFE SCIENCE EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges October 19, 2017
1pm-2:30pm EDT, Online Training
Biosimilars Conference October 24 - 25, 2017
Bethesda,, MD
CRO Oversight Post ICH GCP E6 (R2) Addendum October 25, 2017
Live Date TBD
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Diogo Ribeiro October 26 - 27, 2017
Porto
More Events...

LIFE SCIENCE INDUSTRY EVENTS

Best Practices in CMC Dossier Preparation – Facing Tough Challenges October 19, 2017
1pm-2:30pm EDT, Online Training
Biosimilars Conference October 24 - 25, 2017
Bethesda,, MD
CRO Oversight Post ICH GCP E6 (R2) Addendum October 25, 2017
Live Date TBD
The Investigational New Drug (IND) Submission - Tips to Win the First Time October 26, 2017
1pm-2:30pm EST, Online Training
Diogo Ribeiro October 26 - 27, 2017
Porto
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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