With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.
- No, Biologics Are Not Natural Monopolies
- Making Sense Of Antibody Epitope Claims
- Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across
- Assessing CT-P13 SC’s Impact Across Indications
- Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge
- Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
- Changing Perceptions On Bioprocess Intensification, Continuous Processing
No, Biologics Are Not Natural Monopolies
Biologics are not natural monopolies, as certain individuals continually assert. This assertion threatens future innovations, greater healthcare affordability, and patient access. This article, backed up with data, debunks the myth that biologics are natural monopolies.
Making Sense Of Antibody Epitope Claims
Obtaining certain types of patent rights to antibodies has become increasingly challenging in the U.S. To comprehend this evolution, we must first take a careful look at what antibodies are, and then understand how they are claimed in a patent.
Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across
Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.
Assessing CT-P13 SC’s Impact Across Indications
This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.
Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge
TNF inhibiting biologics still reign supreme when treating immunological diseases. GlobalData believes that Celltrion’s CT-P13 SC will likely see better success than IV infliximab biosimilars in the U.S. In Part 1 of this two-part article series, we assess the factors that may give CT-P13 SC a competitive edge over Remicade and IV infliximab biosimilars.
Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021
This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic.
Changing Perceptions On Bioprocess Intensification, Continuous Processing
Process intensification and continuous bioprocessing are concepts with inconsistent definitions. What's included often varies greatly and, in some ways, has become more about aspirational goal-setting than actual innovation adoption. Here, BioPlan Associates assesses the changing perspectives of 122 bioprocess decision-makers.
BIOSIMILAR WHITE PAPERS
User Experience For Manual Injection Of 2 mL Viscous Solutions Is Enhanced By A New Prefillable Syringe
Although subcutaneous administration improves patient compliance and quality of life by enabling at-home injections, as compared to intravenous or intramuscular route, the associated anxiety, pain, discomfort, and the frequency of injections can play a significant role in patient non-adherence with chronic subcutaneous treatments. In order to address these challenges, through reducing the required frequency of subcutaneous injections and increasing injection comfort for novel biotherapeutics, drug delivery systems are needed to enable the administration of large-volume injections and/or high-viscosity drugs. We developed a pre-fillable glass syringe featuring a stacked 8 mm needle with an ultra-thin wall (UTW) cannula technology as a solution.
Considerations for improving outcome in biopharmaceutical process development8/12/2020
In this article, we take a look at how the biopharmaceutical process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.
Using In-Line Sensors For Real-Time Control9/28/2020
There's a biopharma production shift from manual processes to automated intervention. This paper exemplifies the use of sensors for in-process control of upstream and downstream process parameters.
Early Product Characterization De-Risks Biologics Development6/12/2019
The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to making informed decisions, accelerating development, and reducing risk.
Single-Use Platforms Accelerate Viral Vaccine Development, Manufacturing10/31/2019
Analysts predict the vaccine market could grow at as much as 10.3 percent through 2024 (CAGR). Single-use platforms might be pivotal to meeting that demand.
Business Continuity Program: Maintain Operations During Crises5/5/2020
Get insights into implementing a robust business continuity management program that can help secure supply, reduce risks, and maintain quality in manufacturing operations, through a crisis situation.