Guest Columns

1. Effectively Educating Clinicians And Patients On Biosimilars Across Europe: Getting The Right Message Across 3/31/2021

   Biosimilars are here to stay, so it is essential that the different stakeholder groups (healthcare providers, patients) receive trustworthy and clear information about the principles and the value proposition.

2. Assessing CT-P13 SC’s Impact Across Indications 3/24/2021

   This is the second article in a two-part series exploring the anticipated competitive dynamics for Celltrion’s subcutaneous (SC) infliximab bio-better, CT-P13 SC, in the U.S.The author explores how market dynamics across different autoimmune indications will drive distinct uptake of CT-P13 SC, highlighting the potential impact on TNF inhibitor competition.

3. Subcutaneous Infliximab In The U.S.: Defining CT-P13 SC’s Competitive Edge 3/17/2021

   TNF inhibiting biologics still reign supreme when treating immunological diseases. GlobalData believes that Celltrion’s CT-P13 SC will likely see better success than IV infliximab biosimilars in the U.S. In Part 1 of this two-part article series, we assess the factors that may give CT-P13 SC a competitive edge over Remicade and IV infliximab biosimilars.

4. Regulatory, Legislative Actions Set The Tone For Biosimilars In 2021 3/8/2021

   This article focuses on regulatory and legislative actions in 2020 that may impact the burgeoning biosimilars space in 2021 and beyond. In particular, the authors revisit the implications of the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. 

5. Changing Perceptions On Bioprocess Intensification, Continuous Processing 3/1/2021

   Process intensification and continuous bioprocessing are concepts with inconsistent definitions. What's included often varies greatly and, in some ways, has become more about aspirational goal-setting than actual innovation adoption. Here, BioPlan Associates assesses the changing perspectives of 122 bioprocess decision-makers.

6. 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. 

7. 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.

8. 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.

    

9. 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.

10. 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.