Anna Rose Welch

ARTICLES BY ANNA ROSE WELCH

• Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?

  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.

• The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 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. 

• The Top 5 Biosimilar Developments Of 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.

• Will These Big Biosimilar Questions Be Answered In 2021?

  Biosimilar Development is back with the highly anticipated second installment of its Editorial Board 2021 Outlook series! Here, the experts address the biggest questions they have going into 2021, as well as some of the events, policies, and corporate strategies they hope will help answer these questions.

• The Past, Present, & Future of Biosimilar Manufacturing

  A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.

• Biosimilar Industry Advancements To Watch In 2020

  Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.

• The Top 7 Biosimilar Developments of 2019

  I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.

• Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know

  Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

• FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

  While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

• A Second Reformation: Returning Biosimilar Regulations To Scientific Roots

  In light of BioApproval's Chris Webster’s recent publication and future presentation at the upcoming DIA Biosimilars conference, I spoke with him to learn more about the "Confirmation of Sufficient Likeness" approach and the scientific evidence that has informed this proposed biosimilar regulatory paradigm shift away from Totality of Evidence.