The 4 Most Notable Biosimilar Interchangeability Hurdles
The 4 Most Notable Biosimilar Interchangeability Hurdles

Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.

  • 5 Important Takeaways From The FDA's Revised Quality Metrics Guidance
    5 Important Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  • Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances
    Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  • Should Your Biosimilar Really Be A Biobetter?
    Should Your Biosimilar Really Be A Biobetter?

    A few months ago, Eagle Pharmaceuticals agreed to acquire Arsia Therapeutics.This move will help Eagle partner with biosimilar companies to turn biosimilar candidates into biobetters. As Eagle CEO Scott Tarriff describes, the company’s business model of reformulating and improving existing small molecules is well-suited to the biologics space — especially considering his expectations of how the biosimilar space will play out.

  • Brexit, Trump, What Next? 6 Rules To Succeed In An Era Of ‘Brutal Disruption’
    Brexit, Trump, What Next? 6 Rules To Succeed In An Era Of ‘Brutal Disruption’

    Heard the latest? Elvis is alive and kicking and planning a comeback.  Only kidding … but who knows? After the events of 2016, anything is possible.

  • PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes
    PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes

    The seamless delivery of high quality, effective, and safe medicines to patients is each drug company’s ultimate duty. However, providing medication to patients is by no means effortless, as evidenced by the drug product shortage listings on health authority websites. The availability of medicines is challenged by a variety of factors, one of which is global supply chain segmentation due to global regulatory hurdles imposed on product related post-approval changes (PACs).

  • FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)
    FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)

    In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

  • 2017: A Standstill Year For Biosimilars?
    2017: A Standstill Year For Biosimilars?

    Despite the many positive steps we’ve taken to establish the biosimilar industry today, it seems as though the success of the biosimilar market in the U.S. is still looking hazy. Every conference I’ve gone to has focused on the challenges facing the industry and concerns over the different regulations being established. But CBI’s 12th Biosimilars Summit felt particularly realistic in how it approached those issues.

  • Troubleshooting Bacterial Contamination In Bioreactors
    Troubleshooting Bacterial Contamination In Bioreactors

    One of the most dreaded problems in large scale biomanufacturing is contamination events. These events negatively impact an organization in many ways: lost batches and production time, cost of investigations, cost of decontamination, compliance issues (if there is concern that the process is no longer in control), decreased product quality and patient safety, and lost revenues, depending on the root cause. I was personally involved in defending a recurring contamination investigation before FDA, where any delay in the approval of this blockbuster would have had a negative impact of tens of millions of dollars.

  • Celltrion: Data Transparency Imperative For Biosimilar Success
    Celltrion: Data Transparency Imperative For Biosimilar Success

    Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”

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BIOSIMILAR INSIGHTS

  • Biosimilar Producer Relies On Flexible Development Platform To Speed Time To Market

    To help drive sales, producers of biosimilar medicines seek to gain as much pricing advantage as possible over their products’ reference biological medicines while maintaining as much profit margin as they can. That’s why they are always looking to minimize production costs, especially in raw materials and labor, their largest cost components. While the costs of the former depend on market prices and a buyer’s negotiating skills, the latter can be best reduced through automation and continuous processing.

  • Will Single-Use Standardization Take End User & Supplier Relationship To The Next Level?

    To continue the evolution of single-use technology (SUT) in biopharma, one area that must be secured is SUT supply chain reliability. Without this, a larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.

  • Seed Culture Expansion Process: Reduce Time And Maximize Utilization

    This application note describes how perfusion cell culturing can be used to reduce processing time, simplify operations, and maximize equipment utilization in seed culture expansion processes. For creation of high-density cell banks, Chinese hamster ovary (CHO) cells were expanded using a bioreactor system operated in perfusion mode.

  • Improving Single-Use Film To Achieve Optimal Performance In Biomanufacturing

    The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.

  • Single-Use Extractables and Leachables: Alignment with the BPOG Protocol

    Despite years of discussion and experience, E&L testing approaches for single-use equipment have not yet fully matured into a consensus industry practice. Copious amounts of data have been generated by the industry, but most of it is held under confidentiality. Trade organizations, such as the Bio-Process Systems Alliance (BPSA), of which GE is a member, and suppliers have derived their own approaches to testing. For end users who are adopting single-use (SU) equipment as a manufacturing strategy, this situation becomes unwieldy. The need for a standard approach both to the generation and to the reporting structure of extractables data becomes obvious.

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Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
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Communicating Beyond the Label: FDA's Latest Guidance & Updates March 9, 2017
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Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
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Drug Development 101 – How A Drug Is Made April 5, 2017
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Document Archive and Inspection – Challenges And Tips For Establishing Audit-Proof Processes April 25, 2017
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CellWorld April 25 - 26, 2017
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 EVENTS

Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Communicating Beyond the Label: FDA's Latest Guidance & Updates March 9, 2017
1pm-2:30pm EST, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD) – An Overview March 28, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
BioTech Pharma Summit 2017 March 29 - 31, 2017
Porto

LIFE SCIENCE EVENTS

Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
Communicating Beyond the Label: FDA's Latest Guidance & Updates March 9, 2017
1pm-2:30pm EST, Online Training
BioTech Pharma Summit 2017 March 29 - 31, 2017
Porto
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LIFE SCIENCE INDUSTRY EVENTS

Bioprocess Facility Design - Layout Rules and Configurations March 8, 2017
1pm-2:30pm EST, Online Training
Communicating Beyond the Label: FDA's Latest Guidance & Updates March 9, 2017
1pm-2:30pm EST, Online Training
BioTech Pharma Summit 2017 March 29 - 31, 2017
Porto
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