In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned.
- Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?
- 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers
- The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021
- The Top 5 Biosimilar Developments Of 2020
- Will These Big Biosimilar Questions Be Answered In 2021?
- From “Musty Towel” To “Golden Age:” Biosimilars In 2021 And Beyond
- The Second Wave Of Biosimilars: New Scenarios, New Rules
The Second Wave Of Biosimilars: New Scenarios, New Rules
The arrival of what we could call the first “bio patent cliff” has revealed important lessons that should be taken into consideration when selecting new candidates for the second and third waves.
Bioprocessing Year In Review: 11 Key Trends Accelerated By COVID-19
Despite the morbidity, deaths, and terrible societal disruptions associated with the COVID-19 pandemic, 2020 will have created something of a positive outcome for the bioprocessing sector.
Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity
Most of the development in immunology to date has happened in rheumatologic, dermatologic, and respiratory indications. Nephrology, on the other hand, the medical branch that focuses on kidney diseases, has few approved treatment options outside of those that are expensive and higher risk, such as dialysis and transplants.
Biologics Manufacturing In China: Competition Heats Up Among CMOs & Their Clients
Significant growth of outsourced commercial-scale manufacturing is projected for the near future in China, though certain bottlenecks remain.
Mammalian Biomanufacturing Industry Supply & Demand Trends
While capacity will increase over the next five years, demand for capacity—pandemic aside—will increase at a slightly faster rate. This increase will allow for some short-term loosening of capacity constraints, but after 2024, capacity tightening may occur.
Will Biosimilar Manufacturers Pursue Lower-Revenue Products?
Will biosimilar makers have any motivation to develop biosimilar competitors for biologics earning considerably less in U.S. sales than previous generations? Biosimilar Development decided to do a deeper dive into one of these products, which may represent a broader base of biologic agents beyond autoimmune and oncology agents.
Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA
In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product and when is it appropriate and at what level of detail it should be for each stage of interaction with the FDA.
BIOSIMILAR WHITE PAPERS
Ensuring Strength And Flexibility Of Single-Use Bags In All Applications
The costs are high when leakage occurs during steps that are critical to patient safety. Read how the robustness of Sartorius films makes them safe and easy to use for all process steps and applications.
Strategies To Address The Viral Vector Manufacturing Shortage
Accelerating the production of your viral-vector based therapy requires understanding the strategies and cost-efficiencies available to address the viral vector manufacturing shortage.
Getting Your Investigational Drug Regulatory Ready
Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.
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.
Can mRNA Disrupt The Biopharma Industry?
mRNA has the potential to revolutionize the field of vaccine development. However, it is critical we understand any factors that could impact its successful entry into today’s market.
Scaling A mAb Production Process To A Single-Use Platform
The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.