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.

  • 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

    In my previous article, I argued that biosimilar companies must engage states as partners for successful U.S. market access. This article accepts that premise and also assumes interchangeability will occur at the federal level. My goal is to provide insights, along with several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial. This analysis is based on reading and assessing all 38 of the local statutes addressing biosimilars and my prior experience proposing statutes for local legislatures.

  • 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.

  • Why Biosimilar Companies Should Pay More Attention To U.S. State Governments
    Why Biosimilar Companies Should Pay More Attention To U.S. State Governments

    This article assumes interchangeability will inevitably happen in the United States at the federal level. This inference is based on the direct efforts of FDA Commissioner Scott Gottlieb to increase access for patients to biosimilars, along with other actions by the FDA, such as writing interchangeability guidelines to facilitate approval. 

  • Economics And The Clinic: What Biosimilar Manufacturers Must Consider
    Economics And The Clinic: What Biosimilar Manufacturers Must Consider

    In the second of this two-part article, McKesson Specialty Health's Omar Hafez and Pete Perron discuss how to approach the complex financial landscape in the clinic and help incentivize clinics to use biosimilars.

  • How Should Biosimilar Companies Approach Real-World Evidence?
    How Should Biosimilar Companies Approach Real-World Evidence?

    Real-world evidence (RWE) has become increasingly important for innovative manufacturers looking to convince reluctant payers that their new medicine has a place in patient care. Indeed, many claim the changing nature of the data landscape in healthcare will revolutionize the way we consider evidence, but does this apply to biosimilars? Is there a real need to look at data from actual clinical practice before or after market entry for these products?

  • The Importance Of Humanizing Biosimilars
    The Importance Of Humanizing Biosimilars

    Since I will be unable to attend the upcoming Biosimilar Medicines Conference this year, I welcomed the opportunity to speak with Mylan's and the Biosimilar Medicines Group's Erin Federman about which topics she hopes to see discussed and how certain conversations surrounding biosimilars could be reframed.

  • Pfizer Executives Elaborate On Payer Biosimilar Contracting Goals, Challenges
    Pfizer Executives Elaborate On Payer Biosimilar Contracting Goals, Challenges

    At a recent press conference, Pfizer executives shared a few key updates related to Inflectra’s uptake and the ongoing efforts to work with commercial payers. These updates not only shed more light on Inflectra’s market journey, but also reassured me that progress is being made — even though it’s not regularly broadcast in headlines.

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TRAINING COURSES

World Biosimilar Congress USA 2018 May 23 - 24, 2018
San Diego, CA, CA)
Designing GxP Onboarding Programs for the Life Sciences: Ensuring Employee Success May 24 - 24, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Cleanroom Microbiology – Building A Foundation For Compliance June 14 - 14, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
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!
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!
More Upcoming Courses
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 EVENTS

World Biosimilar Congress USA 2018 May 23 - 24, 2018
San Diego, CA, CA)
Designing GxP Onboarding Programs for the Life Sciences: Ensuring Employee Success May 24 - 24, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error May 29 - 29, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Understanding Cleanroom Microbiology – Building A Foundation For Compliance June 14 - 14, 2018
1pm-2:30pm EDT, Online Training)
Price:  $299 - Includes Bonus Handouts!

LIFE SCIENCE EVENTS

World Biosimilar Congress USA 2018 May 23 - 24, 2018
San Diego, CA, CA
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training
Understanding Cleanroom Microbiology – Building A Foundation For Compliance June 14 - 14, 2018
1pm-2:30pm EDT, Online Training
More Events...

LIFE SCIENCE INDUSTRY EVENTS

World Biosimilar Congress USA 2018 May 23 - 24, 2018
San Diego, CA, CA
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner May 30 - 30, 2018
1pm-2:30pm EDT, Online Training
Understanding Cleanroom Microbiology – Building A Foundation For Compliance June 14 - 14, 2018
1pm-2:30pm EDT, Online Training
More Industry Events

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