Industry Insights

61. What Is Skinny Labeling — And Will It Work For Biosimilars? 2/5/2019

    “Skinny labeling” refers to the practice of follow-on drug manufacturers seeking approval for some but not all the indications for which the branded drug has been approved. In the small molecule drug world, it has been a successful strategy for generic drug makers to get around the brand’s follow-on “new use” patents that keep the brand from falling off the “patent cliff” long after the expiration of the original patents. This strategy is starting to be used in the biosimilar realm.

62. Expand Capacity In Buffer Management 2/1/2018

    Biomanufacturing requires large volumes of buffers, and preparation of these liquids can quickly become a bottleneck. Here, two options that can help intensify your large-scale buffer management are presented.

63. Pharma Industry Braces For A No-Deal Brexit 3/22/2019

    Chaos reigns supreme in London at the moment, as British Prime Minister Theresa May struggles to find a graceful way for the United Kingdom to exit from the European Union (EU). Meanwhile, pharmaceutical manufacturers must prepare for multiple potential outcomes, including a “no-deal” (or “hard”) Brexit.

64. Key Takeaways From The FDA’s New Continuous Manufacturing Guidance 3/15/2019

    The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.

65. FDA Guidelines Make More Work for CMOs, But Safer Products for Consumers 9/27/2017
66. "Validation" Or "Qualification" – What’s The Difference? 6/25/2019

    What is the difference between qualification and validation? This question comes up frequently with both internal and external clients. 

67. Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End 4/23/2019

    Within the last few years, the FDA has taken steps to approve more biosimilar products and has committed to providing for a competitive landscape. The three latest biosimilars to be approved by the FDA have all been biosimilars to Herceptin. Further, Pfizer’s Trazimera, the most recently approved trastuzumab biosimilar, has sparked intrigue. As a result, Genentech is bracing for Herceptin biosimilar commercial launches in 2019.

68. Providing Solutions At Fair Value: A Spray Drying Case Study 3/18/2020

    Pharmaceutical companies need CDMO partners that provide solutions at fair value. This CMO has a long history of investing in new technologies with innovators to help their customers achieve their goals, and one recent example is the construction of a new Hastelloy spray-drying unit.

69. PDA Position Paper: A Call For Reform In Global Post-Approval Change Processes 2/3/2017

    The availability of medicines is challenged by global supply chain segmentation due to global regulatory hurdles imposed on product related post-approval changes (PACs). Because of the many challenges posed by differing global regulatory requirements, many companies find it easier to postpone or refrain from planning advancements. As such, it is time for both industry and regulators to transform the current paradigm for PACs.

70. Commissioner Gottlieb, CAR T-Cells, & The Future Of Rare Disease Therapies 9/27/2017

    This article explores some of the policy changes happening now in the regulatory rare disease space as the FDA’s leadership team implements these changes at the agency.