GUEST COLUMNISTS

• Regulatory, Legislative Actions Set The Tone For Biosimilars In 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. 

• Changing Perceptions On Bioprocess Intensification, Continuous Processing

  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.

• The BPCIA And Declaratory Judgment: The Real Dance Partners?

  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. 

• The Opportunities & Challenges Of India’s Biologics Market

  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 Strategies To Address The Biggest Concerns Facing Generic Drug Makers

  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.

   

• 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.