Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them
Patentable Subject Matter Barriers For Biosimilars — And How To Overcome Them

Patents are the most important requirement for successful biologic commercialization, yet stakeholders often have little understanding of the unique obstacles encountered in this field, especially for biosimilars. Biologics may treat less than 2 percent of the U.S. population, but they account for 38 percent  of all U.S. prescribed drug spending.

  • Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs
    Samsung Bioepis: Applying The "Hunger" For Biosimilars To Novel Drugs

    Since last year's feature article celebrating Samsung Bioepis' fifth anniversary, the company has seen a number of approvals and launches and has established a novel biologics development partnership. As such, I jumped on the opportunity to learn more about the company's ongoing efforts to realize a lower COGS, speed production, and manage risk in biosimilar and biologics development.

  • Working With Patient Groups To Strengthen Biosimilar Understanding In The U.S.
    Working With Patient Groups To Strengthen Biosimilar Understanding In The U.S.

    When it comes to biosimilars, building confidence that these medicines can deliver the same experience as a branded medicine will ultimately require more than communicating successful clinical trial results. Here, we unpack several strategies patient advocacy groups have indicated to be essential for successfully reaching patients.

  • Can Real-World Evidence Improve Market Access For Biosimilars In The U.S.?
    Can Real-World Evidence Improve Market Access For Biosimilars In The U.S.?

    A look at the role real-world evidence (RWE) can play in increasing the uptake of biosimilars in the U.S. market and some of the challenges in leveraging the potential of RWE.

  • Why The Biosimilar Industry Should Celebrate The Latest FDA News
    Why The Biosimilar Industry Should Celebrate The Latest FDA News

    A number of articles already provide a synopsis of the FDA's reversal on the Statistical Approaches draft guidance. But I felt it was necessary to add one more article to this conversation, not only because this action is unprecedented thus far in the biosimilar industry, but it also suggests an important turning point in the FDA’s biosimilar oversight.

  • “Locally Brilliant": 3 Biosimilar Market Access Experiences
    “Locally Brilliant": 3 Biosimilar Market Access Experiences

    Mundipharma expert Richard Trollope shares his learnings from launching three different biosimilar molecules (Remsima, Truxima, and Herzuma) in the EU and discusses the questions that remain about the newly launched Herzuma, recently introduced in the U.K. and Germany.

  • 4 Conversations Integral To Building Biosimilar Partnerships
    4 Conversations Integral To Building Biosimilar Partnerships

    Thanks to Mundipharma's Richard Trollope, I not only got the inside scoop on what makes a biosimilar partnership specifically a biosimilar partnership, but also Mundipharma’s journey in launching Remsima, Truxima, and, most recently, Herzuma.

  • How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access
    How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access

    An in-depth discussion that explores the recent developments in the U.S. marketplace from both the regulatory and payer viewpoints, with an emphasis on how these may lead to opportunities for biosimilar manufacturers.

  • Critique Of Literature Review Highlights Areas For Future Study And Education
    Critique Of Literature Review Highlights Areas For Future Study And Education

    A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.

  • Market Access Impediments: Where Should Biosimilars Go From Here?
    Market Access Impediments: Where Should Biosimilars Go From Here?

    In this first article of a three-part roundtable industry experts share their insights on the status of the market for biosimilars and explore some of the reasons for the difference between the U.S. and Europe.

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TRAINING COURSES

The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to Comply July 17 - 17, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
CRO Oversight Post ICH GCP E6 (R2) Addendum July 18 - 18, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
13th Annual Global Forum on Manufacturing Execution Systems August 13 - 14, 2018
Philadelphia, PA)
4th Annual Data Integrity Validation August 15 - 16, 2018
Cambridge, MA)
How to Write SOPs That are GCP Compliant and Implementable August 16 - 16, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
4th Annual 340B Manufacturer Summit August 21 - 22, 2018
Arlington, VA)
Bio/Pharma Forum on the State of Medicare Reform August 21, 2018
Arlington, VA)
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 EVENTS

The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to Comply July 17 - 17, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
CRO Oversight Post ICH GCP E6 (R2) Addendum July 18 - 18, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!

LIFE SCIENCE EVENTS

CRO Oversight Post ICH GCP E6 (R2) Addendum July 18 - 18, 2018
1pm-2:30pm EDT, Online Training
Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training
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LIFE SCIENCE INDUSTRY EVENTS

CRO Oversight Post ICH GCP E6 (R2) Addendum July 18 - 18, 2018
1pm-2:30pm EDT, Online Training
Cleanroom Microbiology – A Foundational Introduction July 24 - 24, 2018
1pm-2:30pm EDT, Online Training
Writing Effective 483 and Warning Letter Responses August 2 - 2, 2018
1pm-2:30pm EDT, Online Training
Communicating Beyond the Label: FDA’s Finalized Guidances & Updates August 8 - 8, 2018
1pm-2:30pm EDT, Online Training
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