GUEST COLUMNISTS

• 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.