Can a patent claim millions of different antibodies based on their function alone? Tens of thousands? Hundreds? What if the patent gives a plug-and-play road map to make and evaluate the antibodies through routine testing? Whatever the CAFC’s answer, one thing is sure: It will affect how biologic innovators use functional claiming and whether patentees or challengers are more likely to win future lawsuits in the biologics and biosimilar arena.
- Private Equity: A New Pillar For Biosimilar Development?
- Is Biopharma Suffering From Thalassophobia? FDA Regulator Says Yes
- Weighing The Potential Of Humira Biosimilars In The U.S. — Expected Winners And Losers
- The Intriguing FDA News You May Have Missed
- Weighing The Potential Of Humira Biosimilars In The U.S. — Competitive Dynamics Analysis
- Rituxan Biosimilars In The Real World: Market And Clinical Considerations
- Biosimilar News You May Have Missed During COVID-19
Weighing The Potential Of Humira Biosimilars In The U.S. — Expected Winners And Losers
This is the second article in a two-part series exploring the anticipated competitive landscape for Humira (adalimumab) biosimilars following their U.S. launch in 2023. In this part, we evaluate the potential for individual adalimumab biosimilar products, comparing and contrasting the agents based on a number of important factors, including order of market entry, company resources and reputation, and product characteristics.
Weighing The Potential Of Humira Biosimilars In The U.S. — Competitive Dynamics Analysis
This two-part article series explores the factors differentiating the Humira (adalimumab) biosimilar market from that of infliximab biosimilars, which could lead to stronger uptake of these products in the U.S. In Part 1, we focus on the unique competitive dynamics within the adalimumab biosimilar market.
FDA Releases Guidance On Normal GMP Operations During COVID-19
Most FDA guidance on COVID has been associated with tools to combat the pandemic. This new guidance should be read by all drug and biologic manufacturers, whether or not they produce COVID-related products.
Expectations Vs. Reality: The Financial Impact Of Market Delays On Biosimilars
Given originators' actions and the resulting commercialization risks, as well as the inherent technical risks of biosimilar drug development, how can one possibly expect a biosimilar to launch at a 90 percent discount to the brand? Let’s create a hypothetical example that closely mimics the reality biosimilar manufacturers are facing today and discuss how that impacts the discounts they can provide.
End Of The Enbrel Battle: How Amgen Beat Sandoz
This case serves as a reminder that sometimes it is impossible to fully evaluate the likelihood of success in biosimilar litigation before the challenge begins.
An Update On 2020 U.S. Biosimilars Regulation & Litigation
The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.
Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know
The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. This two-part article series explores some of the unanswered questions raised in these two cases. In Part 1, Genentech v. Amgen was discussed. Here, Part 2 delves into the remaining questions following Janssen v. Celltrion.
BIOSIMILAR WHITE PAPERS
Three Options To Viral Vector Manufacturing Capacity
A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.
Developing TIL Therapies: Sample Collection And Processing
While it has been advanced over many years, the process of developing TIL therapies still suffers from certain challenges. This article attempts to lay bare some of these challenges and discuss how novel technological solutions can help overcome them.
Robust Field Guide To qPCR
qPCR remains the gold standard for validation of microarray and next generation sequencing data and the method of choice for both clinical and basic research labs for a wide range of applications. However, there remains general concern about the production of data that truly reflects the tested experimental conditions. We have developed a comprehensive guide to performing the ultimate qPCR experiment. The following is a snapshot of the critical steps needed to achieve excellent results.
Counting DNA Molecule By Molecule
Digital PCR is an established nucleic acid (NA) quantification technology, which enhances the broad use of PCR across molecular biology laboratories globally through improved precision and accuracy. Organizations that impact the quality of nucleic acid measurement and testing, adopted digital PCR early on and have since been pioneering its use for improved accuracy and precision in NA measurement. Ultimately, this will positively impact the quality of NA measurements generally and, more specifically, clinical NA testing. Molecular counting of nucleic acid molecules is the next measurement paradigm.
Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up
In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.
Cell Therapy Scale-Up Strategies For Commercial Success
To achieve commercial success, a developed process must be scalable and suitable for a manufacturing environment. The scaling strategy depends on the type of cell therapy. This article discusses options for cell therapy process development and validation that minimize risks through quality control (QC), optimization, scaling, closing, automation, and assay development, all in order to prepare for successful commercial production.
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
The COVID-19 pandemic has thrown the entire pharmaceutical industry, as well as patients, providers, and sites of care for a loop. Though small molecule novel treatments and generics have seen much more pronounced impacts from market shut-downs and supply-chain disruptions, the biologics and biosimilars industry has also been striving to understand how the pandemic will alter availability and usage of biologic products. This collection of articles surveys a wide array of considerations facing biopharma and biosimilar companies, including the pandemic's impact on regulatory interactions, product supply and demand, materials sourcing, and market access and uptake.More Content Collections
LIFE SCIENCE EVENTS
China GCP 2020: Understanding and Implementing New Compliance Requirements
October 29 - 29, 2020
11am-12:30pm EDT, Online Training
Validation Challenges for Bioassays
November 3, 2020
Excel - Using Macros to Automate Repetitive Tasks and Processes
November 4, 2020
Design History Files (DHF), Device Master Records (DMR)
November 4, 2020
Microsoft Excel- Advanced Charting
November 5, 2020