EDITOR'S DESK

  • 3 Countries To Watch In The MENA Region
    3 Countries To Watch In The MENA Region

    Though there is a large handful of countries that, to date, don’t have biosimilar pathways established, a few countries have been slowly gearing up to be leaders in paving the way for biologics and biosimilars. In this article, I’ll discuss the potential of these three markets, as well as the business considerations Challand highlighted for companies considering entering the MENA region.

MENA: Biosimilar Market Challenges And Regulatory Considerations

Throughout her presentation, Challand gave us a good look at the current state of the biologics market in MENA and the ongoing educational and collaborative efforts that could help shape the markets in this region. She also shared several important considerations for regulators and biosimilar companies looking to expand their business to MENA.

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.

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GUEST CONTRIBUTORS

  • “Work Harder” — And Other Ways To Completely Miss The Mark On Quality
    “Work Harder” — And Other Ways To Completely Miss The Mark On Quality

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone else is exhibiting a form of the psychological bias known as the bandwagon effect, in which they go along with the rhetoric because everyone else is.

  • Mystery And Danger: Flammables And Oxidizers In Pharmaceutical Filling Operations
    Mystery And Danger: Flammables And Oxidizers In Pharmaceutical Filling Operations

    One of the most intriguing experiences we have had in our business in the last 20 years is being faced with a seemingly simple water-soluble topical or device component fill and then being told it is an organic peroxide! When we in our nice, safe water-based business (leave out liposomes) are faced with the compounding fire/electrical/OSHA compliances along with our GMP issues, it starts to read like a 1940s detective mystery.

  • The China Biosimilars Market: Rise Of A Potential Powerhouse
    The China Biosimilars Market: Rise Of A Potential Powerhouse

    Since the introduction of similar biological medicinal products in the EU in 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the United States. How does the rise of the China biosimilars market fit into this established picture?

  • Military Tool For Vulnerability Assessment: The CARVER + Shock Technique

    CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.

  • Techniques For Risk-Based Validation Using ASTM E2500

    ASTM standard E2500, Specification, Design, and Verification of Pharma and Biopharma Manufacturing Systems and Equipment, elevates risk-based validation as a critical aspect of GMP manufacturing. This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective

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Writing Effective 483 and Warning Letter Responses May 23 - 23, 2019
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Effective Batch Record Review – Getting It Right The First Time June 18 - 18, 2019
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