Guest Columns

1. The BPCIA And Declaratory Judgment: The Real Dance Partners? 2/17/2021

   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. 

2. The Opportunities & Challenges Of India’s Biologics Market 1/27/2021

   Biosimilar drugs, due to their affordability, can play an important role and allow the Indian government to have a better healthcare system. However, as issues remain on the regulatory and manufacturing sides, India needs to see strong improvements to compete and appear as an important hub nationally and internationally.

3. 3 Strategies To Address The Biggest Concerns Facing Generic Drug Makers 1/13/2021

   Without changes in the market for generics, profits will likely continue to erode in the sector as products become more commoditized. Generic drug makers do have some recourse to help improve margins. We’ve outlined three approaches that are not mutually exclusive for generic drug manufacturers’ future success. Each has its own set of investment requirements, risks, and growth potential.

    

4. The Second Wave Of Biosimilars: New Scenarios, New Rules 12/15/2020

   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.

5. Bioprocessing Year In Review: 11 Key Trends Accelerated By COVID-19 12/11/2020

   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.

6. Nephrology Sector Of The Immunology Market: A Major Biopharma Development Opportunity 12/8/2020

   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. 

7. Biologics Manufacturing In China: Competition Heats Up Among CMOs & Their Clients 12/1/2020

   Significant growth of outsourced commercial-scale manufacturing is projected for the near future in China, though certain bottlenecks remain.

8. Mammalian Biomanufacturing Industry Supply & Demand Trends 11/24/2020

   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.

9. Will Biosimilar Manufacturers Pursue Lower-Revenue Products? 11/10/2020

   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.

10. Interacting With FDA During Biosimilar Development: From Initial Advisory Meeting To BLA 11/3/2020

    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.