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.

  • Considering A Future In Biosimilars: The Small Biotech Perspective
    Considering A Future In Biosimilars: The Small Biotech Perspective

    A small biotech company faces specific challenges when navigating both the biosimilar and the innovative space. I wanted to get a better sense of how smaller companies originally defined as biosimilar pure-plays, like Pfenex, are ensuring longevity in the biosimilars space.

  • Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility
    Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility

    I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.

  • Cross-Sector Intelligence: The Prospects For Data Convergence In Biopharma
    Cross-Sector Intelligence: The Prospects For Data Convergence In Biopharma

    This two-part series of articles looks at how the application of new technologies around data analytics has proven beneficial for the biopharmaceutical industry and regulators alike. The first article explored how technological advancements such as use of real-time data, predictive modeling, and artificial intelligence are gaining regulators’ acceptance and enabling the more efficient development of effective drugs and treatment solutions. This article examines the current environment of collaboration in the industry, along with technologies that will open opportunities to utilize data across life science sectors, including cross sector intelligence (CSI), the convergence of information across multiple sectors, enabling intelligent data-driven decision making.

  • Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know
    Recent Supreme Court Decisions On Inter Partes Review — What Biosimilar Developers Need To Know

    The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.

  • Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities
    Amgen And Avalere Reports Reveal "Upside Down" Payer Biosimilar Realities

    While Amgen’s report shares payers’ broad considerations about biosimilars and the impact they’d have, Avalere’s report digs more deeply into the available data from payers to show just how biosimilars are stacking up. And, frankly speaking, I found some of the information quite concerning.

  • How To Win Over U.S. Payers On Biosimilars
    How To Win Over U.S. Payers On Biosimilars

    Payers are widely considered the gatekeepers to the U.S. market for biosimilars. If you can address their specific concerns related to price, contract terms, evidence, FDA designation, and other factors, they will eagerly grant you access to patient populations who are yet to reap the benefits of biosimilars. Easy, right?

  • How Social Media Can Support #Biosimilars
    How Social Media Can Support #Biosimilars

    In the countless moments I’ve spent scrolling through social media platforms, a few ways they’re being used by pharma companies, organizations, and patients have caught my eye. Though they aren’t all posts about biosimilars, I think they’re worth calling attention to as potential strategies for biosimilar companies.

  • How These Key Learnings Shaped Pfizer’s Biosimilar Business
    How These Key Learnings Shaped Pfizer’s Biosimilar Business

    It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars.  

  • The Impact Of Regulatory & Analytics Evolution On The Biopharma Industry
    The Impact Of Regulatory & Analytics Evolution On The Biopharma Industry

    This two-part article explores the use of various tools and the emergence of intelligent solutions in the industry.The first part provides an overview of how technological advancements and data analytics are critical in enabling regulators and the life sciences industry. 

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BIOSIMILAR INSIGHTS

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TRAINING COURSES

ACI’s 9th Annual Summit on BIOSIMILARS June 25 - 27, 2018
New York, NY)
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements June 26 - 26, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance June 27 - 27, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You July 11 - 11, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
21 CFR Part 11: Understanding the ERES Regulation for Compliance Success July 12 - 12, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
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!
13th Annual Global Forum on Manufacturing Execution Systems August 13 - 14, 2018
Philadelphia, PA)
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Anna Rose Welch article header

 EVENTS

ACI’s 9th Annual Summit on BIOSIMILARS June 25 - 27, 2018
New York, NY)
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements June 26 - 26, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance June 27 - 27, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You July 11 - 11, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!

LIFE SCIENCE EVENTS

ACI’s 9th Annual Summit on BIOSIMILARS June 25 - 27, 2018
New York, NY
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training
Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You July 11 - 11, 2018
1pm-2:30pm EDT, Online Training
More Events...

LIFE SCIENCE INDUSTRY EVENTS

ACI’s 9th Annual Summit on BIOSIMILARS June 25 - 27, 2018
New York, NY
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training
Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You July 11 - 11, 2018
1pm-2:30pm EDT, Online Training
More Industry Events

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