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.

  • 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. 

  • 6 Ways Biosimilar Companies Should Engage State Governments
    6 Ways Biosimilar Companies Should Engage State Governments

    This article provides insights and several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. 

  • Why Medicare Pass-Through Status Must Remain For Biosimilars
    Why Medicare Pass-Through Status Must Remain For Biosimilars

    A U.S. House-passed version of the Continuing Resolution (CR) threatened to remove an integral tool for biosimilar reimbursement under Medicare Part B. Though this tool (pass-through status) will remain for biosimilars, this ultimately raises questions about the importance of pass-through status and how eliminating it could impact the industry as a whole.

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Writing Effective 483 and Warning Letter Responses June 19 - 19, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Core Competencies of a World-Class Medical Affairs Team June 20 - 20, 2018
1pm-2:00pm EDT, Online Training)
Price:  $199 - Includes Bonus Handouts!
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!
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New York, NY
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Writing Effective 483 and Warning Letter Responses June 19 - 19, 2018
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ACI’s 9th Annual Summit on BIOSIMILARS June 25 - 27, 2018
New York, NY
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