EDITOR'S DESK

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

2018 Outlook: Biosimilar Trends To Watch

Last week, I published the first installment of a three-part roundtable discussion highlighting which 2017 trends/occurrences were most notable to the members of Biosimilar Development’s editorial advisory board. In addition to discussing 2017’s impact on the future of the industry, these experts also shared their thoughts on what to expect in 2018.

Top 5 Biosimilar Developments Of 2017

These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns.

Biosimilar Evolutions To Watch For In The New Year

Experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.

What U.S. Biosimilar “Traditions” Need To Be Broken In 2018?

You may feel “tradition” is not yet a realized concept in the biosimilar industry — and I would agree with you. But this didn’t stop me from asking several experts which areas they felt could stand more attention or redirection in the future. And they left no stone unturned.

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GUEST CONTRIBUTORS

  • An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations
    An Introduction To Analytical Instrument Qualification & Validation — Meeting FDA Expectations

    According to the FDA and other regulatory agencies, analytical instruments should be under the same strict control as manufacturing equipment. Analytical instruments provide critical scientific data about a manufactured product. This data ensures confidence that a quality product has been manufactured and is appropriate and safe for sale to the public. Therefore, as manufacturers, we are bound to ensuring all of our equipment is strictly controlled. Analytical instruments must be qualified, just as manufacturing equipment. We have to show consistency, reliability, and repeatability to ensure the quality of the drugs we produce. The FDA's findings of deficiencies concerning analytical instrument qualification indicate it expects definitive evidence that instrument qualification schedules satisfactorily control manufacturing processes as well as testing processes.

  • Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain
    Rapid Growth In Life Science Sector Constrains Capital Projects Supply Chain

    According to the latest PharmSource Trend Report, Bio/Pharma CapEx Trends 2016, biopharma companies have invested over $150 billion in new plants and equipment in the past five years. As this sector continues on an upward trend, it is placing significant pressure on the supply chain. Mother Nature in California, Texas, Puerto Rico, Mexico, and Southeast Asia and Amazon’s much-anticipated HQ2 serve as further reminders to plan for mitigating cost and schedule project impact.

  • How To Build A Value-Added GMP Supplier Management Program
    How To Build A Value-Added GMP Supplier Management Program

    Typically, supplier management programs use a supplier survey or an on-site audit to verify if a supplier is compliant with the requirements of a standard or regulation. However, for a supplier management program to provide added value to an organization, the supplier evaluation should look beyond the requirements of a standard or regulation. A value-added supplier management program should also consider items such as supplier capability, capacity, and contingency planning.

  • Reviewing FY2017 FDA 483s: Training Failures Or A Learning Paradigm?

    I find it interesting to evaluate the FDA 483 data, year after year, and see the same pattern of non-compliance. An interesting response can be observed at conferences when this data is presented: Everyone begins to frantically write down the numbers.

  • Why You Should Engage With Regulatory Early In Product Development

    The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.

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