EDITOR'S DESK

  • Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway
    Regulatory Consistency: How To Fix The U.S. Biosimilar Pathway

    Though the FDA has taken great efforts in the past year to stand up for biosimilars and establish the BAP, one expert argues the agency can do more to confidently and simply underscore the quality of biosimilar products and to reconsider the need for the additional studies required of biosimilars, especially — but not just limited to — clinical studies.

Biosimilars, Biobetters, Or Both?: Report Highlights Manufacturing Considerations

I sat down with Kate Hammeke, VP of Industry Standard Research to discuss the biggest surprises or takeaways from this year’s report about the industry’s biologics and biosimilars manufacturing goals. But the conversation also evolved to some of the larger trends Hammeke expects to see impacting the biosimilar players in the future.

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.

New U.S And Canadian Facilities Boosting Biologics Capacity

Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

Why Biosimilars Won’t Be “A Stake In The Heart Of Innovation”

There has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline, "Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?"

More From Our Editors

GUEST CONTRIBUTORS

  • Cryogenic Transport For Gene Therapy Products — Exploring The Pros And Cons
    Cryogenic Transport For Gene Therapy Products — Exploring The Pros And Cons

    The ultimate success of gene and cell therapy products relies on the seamless delivery of a potent drug product to patients. The pharmaceutical supply chain is inherently complex; however, gene therapies face additional roadblocks such as ever-changing regulatory compliance, chain of custody due to the personalized nature of autologous therapies, patient demand, and scalability from clinical to commercial. Moreover, the complexity of the delivery process is exacerbated by the temperature- and time-sensitive nature of immunotherapy products.

  • Biosimilars And The BPCIA: Past, Present, And Future
    Biosimilars And The BPCIA: Past, Present, And Future

    While the biosimilar market in the U.S. has gotten off to a relatively slow start compared to Europe, where biosimilars have been available since 2006, it has recently gained momentum and will continue to grow in the coming years as more “blockbuster” biologics lose regulatory exclusivity and patent protection. Here we review our observations in the biosimilar space since the enactment of the 2009 Biologics Price Competition and Innovation Act (BPCIA) and our view of the future of biosimilars and related patent disputes.

  • FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say
    FDA Guidance On Premarket Pathways For Combo Products — What It Does (And Doesn’t) Say

    Last month, the FDA published the draft guidance “Principles of Premarket Pathways for Combination Products.”  The document describes what a combination product is and how to interact with the FDA when developing a combination product, and it identifies some of the principles the agency uses in determining what type of premarket submission should be made. 

  • Increasing Biosimilar Competition: Trends In Government Responses

    A variety of stakeholders including the FDA, Congress, hospitals, and consumers are in agreement — biosimilars have not penetrated the market as expected. By our count, 18 biosimilars have been approved by the FDA since the passage of the Biologics Price Competition and Innovation Act (BPCIA), but only seven have come to market. Over the past year, a number of governmental bodies have focused on this issue and how to remedy it.

  • FDA’s First DSCSA Warning Letter — A Closer Look

    The FDA issued the first warning letter citing failure to comply with requirements of the DSCSA amendments to the FD&C Act. This article takes a close look at this warning letter, but first it examines why McKesson may have received the first warning letter in this category, and explains why pharmaceutical manufacturers should care and what precautions they should take.

More From Guest Contributors

BIOPROCESSING WHITE PAPERS

More Bioprocessing White Papers

INDUSTRY INSIGHTS

  • Cost Savings And Speed: The Untapped Value Of A Single-Source Solution
    Cost Savings And Speed: The Untapped Value Of A Single-Source Solution

    Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success.

  • Selecting A CMO: Top Considerations
    Selecting A CMO: Top Considerations

    Choosing the right contract organization to handle the development and manufacturing of a drug product is of critical importance. You’re putting your supply chain, your brand’s reputation, and patient safety in a partner’s hands. Here are some tips to increase confidence in your decision and ensure a successful outcome.

  • Keeping Up With Viral Safety Trends In Bioprocessing
    Keeping Up With Viral Safety Trends In Bioprocessing

    Understand the new technologies and methodologies that are emerging for both producing and testing biopharmaceuticals as the industry is entering a new era of viral safety assurance.

  • BPOG Extractables Testing Protocols: Working With Multiple Single-Use Components
    BPOG Extractables Testing Protocols: Working With Multiple Single-Use Components

    Understand the analytical challenges faced when implementing the BPOG protocol for four SUS components.

  • The Pivotal Role Of Standardization In FFPE Tissue Block Collection
    The Pivotal Role Of Standardization In FFPE Tissue Block Collection

    The process of formalin-fixed paraffin-embedding (FFPE) emerged in the late 19th century as a valuable histological method for stabilizing and preserving the morphology and cellular details of tissue samples.  In 2017 the human tissues segment was estimated to account for the second largest share of the global biobanking market by sample type. This is attributable in large part to the expanded use of these tissues as molecular biomarkers of disease, primarily in oncology, using immunohistochemical and genetic-based assay systems. 

More Industry Insights

LIFE SCIENCE INDUSTRY EVENTS

Developing a Part 11 Compliance Plan in Clinical Research March 26 - 26, 2019
1:00 PM - 2:30 PM EDT
Complimentary Bioprocess Workshop March 27, 2019
North Carolina State - BTEC, NC
INTERPHEX April 2 - 4, 2019
New York, NY
More Industry Events