• Patent Transparency For Biologics & Biosimilars: The Revamped Purple Book

    The FDA recently updated the “Purple Book” — a database containing information about all licensed biological products — to include, for the first time, patent information relating to biologics as well as FDA regulatory exclusivity information.

  • How To Enhance “Operational Learning” In Biopharma

    According to conventional wisdom in biopharma, operational learning is derived from existing practices, including inspections, audits, deviation investigations, and gemba walks. What is often missing is the necessary understanding of the “how.” This article provides advice, as well as lessons learned from Takeda and Biogen.

  • Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances

    In the U.S., you're grappling with how to set up a fully interoperable electronic system for securing and tracing products across industry sectors per the Drug Supply Chain Security Act (DSCSA) by Nov. 2023. Here's how to navigate the key requirements, as well as the FDA's four new guidances on the subject released in June.

  • 5 Foundations Of Lean Leadership For Pharmaceutical & Medical Device Professionals

    Every life sciences company, now more than ever before, is on a journey to provide greater returns to stakeholders by manufacturing products at better quality and lower cost, which is the aim of lean manufacturing. However, many people forget about the cultural and leadership aspects of lean, which at its foundation are responsible for the success or failure of a lean transformation. 

  • Emerging Technologies In The Delivery Of Proteins & Peptides

    The limited ability to selectively deliver new drug molecules in the forms of peptides and proteins remains a significant challenge. Therefore, new materials and manufacturing techniques are emerging to meet the challenges associated with the formulation and delivery of biopharmaceuticals and pharmaceuticals.

  • New US Legislation Creates Momentum For Biosimilars

    Most biosimilars (follow-on biologic products) still only have shares below 50% in the U.S., which is far different than market shares in Europe. One major reason is a mistrust around biosimilars’ safety and efficacy. Congress has stepped in to address that issue through the Advancing Education on Biosimilars Act of 2021, with the goal of encouraging rapid uptake soon after biosimilars become commercially available.

  • Data Integrity In Supply Chain Risk Management During Zero Trust

    Due to the pandemic, we have had to reconsider our approaches to supply chain risk management and to develop new and creative risk management strategies and tactics in response. This article examines how data integrity principles mitigate ALCOA concerns during this period of zero trust.


  • QRM For Filter Integrity Testing: Complying With EMA's Future Annex 1

    Quality Risk Management (QRM) is a systematic process for dealing with risks to the quality of a pharmaceutical product throughout its lifecycle. Although QRM is not new, the regulatory focus on QRM will increase with the arrival of Annex 1 of the EMA. Integrity testing of sterile filters is a key focus of QRM as it is a fundamental element of sterility assurance. This article points out the insufficiency of traditional QRM for filter integrity testing and advocates a comprehensive approach that allows the identification and avoidance of possible errors.





The debate over whether the biosimilar regulatory paradigm can shift away from comparative efficacy trials has intensified over the past few years. This collection of articles serves as a snapshot of the many different components of this ongoing discussion.

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