Biosimilar Regulatory solution center

1. Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise 5/5/2021

   With the crossing of President Biden's 100th day in office, the administration still hasn’t nominated an FDA commissioner candidate, a delay that daily weakens the FDA and undermines the agency’s ability to act boldly and decisively in order to face the challenges caused by the pandemic and its aftermath. This article makes the case for what traits we need to see in an FDA leader and who would fit the bill.

2. FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities 5/3/2021

   On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.

3. 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. 

4. 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.

5. Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business? 1/20/2021

   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.

6. The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 2021 1/6/2021

   As you’ll read in the following responses, increased competition in 2021 is on the minds of many. How that competition unfolds has yet to be determined. But if one thing is clear, it’s that the industry has many exciting tools at its disposal to bolster biosimilar competition in 2021. 

7. The Top 5 Biosimilar Developments Of 2020 12/30/2020

   Though 2020 felt like an endless descent into Dante’s Nine Circles of Hell, I wanted to end the year as I typically do: with a column highlighting the most important and positive biosimilar developments from the past 12 months.

8. 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.

9. Biosimilar Experts Reflect On 2020’s Greatest Biosimilar Achievements 12/9/2020

   As the amazing members of the Biosimilar Development Editorial Board emphasize here, there is a lot to be thankful for in the biosimilar world. Check out the first of what will be a four-part series showcasing the editorial board’s thoughts on the past year and the year(s) ahead.

10. Why Severability Should Be Every Biosimilar Makers’ Rallying Cry In 2021 11/25/2020

    In the upcoming months, the Supreme Court will (hopefully) be deciding whether Congress intended for the entire ACA to survive should individual provisions be found unconstitutional. So, for better or worse, the biosimilar industry has a few more months of pondering the (excruciating) “what ifs” around the future of the BPCIA.