In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.
- 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
- Bioprocessing Year In Review: 11 Key Trends Accelerated By COVID-19
- Biosimilar Experts Reflect On 2020’s Greatest Biosimilar Achievements
- Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity
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.
Mapping The Development Of A Biosimilar Candidate: Analytical & Regulatory Decisions
This article, the first in a two-part series, details the biosimilar development path to identify and evaluate critical quality attributes for both the candidate biosimilar and the reference product, along the regulatory timeline.
Federal Circuit To Decide Limits On Functional Claiming Of Isolated Monoclonal Antibodies
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.
BIOSIMILAR WHITE PAPERS
Process Effects On Drug Product Quality In Pharmaceutical Manufacturing—A Validated Measurement Process
This whitepaper discusses the importance of understanding how critical process parameters can impact a product’s critical quality attributes, and how a systematic approach with validated SPR assays can help in this respect.
Using In-Line Sensors For Real-Time Control
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.
Single-Use Systems For Vaccine Manufacturing
Next-gen vaccines will leverage recombinant approaches and intensified single-use systems (SUS) to increase capacity at reduced costs, but SUS suppliers will need to overcome regulatory challenges.
Biosafety Considerations For Single-Use Bioreactors
Single-use bioreactors address some key challenges the industry faces by decreasing time-to-market, reducing validation efforts, increasing flexibility, reducing investment costs and optimizing cost of goods.
Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy
Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy.
More Efficient Bispecific Antibody Purification With Fewer Steps
A single-step downstream process using protein A chromatography to purify a bispecific antibody (BsAb) in early screening has been successfully developed to replace an existing-three step process.