Morningstar

Alvotech Shares Rise After FDA Okays Simlandi Manufacturing Process

Provided by Dow Jones

By Chris Wack 




  Alvotech shares rose after the company said the Food and Drug Administration approved a new manufacturing process for Simlandi, its biosimilar to Humira. 



  The stock was 8% higher, at $5.41, in morning trade, and is 37% lower in the past 12 months. 



  The biotechnology company said the FDA approval allows it to introduce Process 2.0 for the manufacture of adalimumab drug substances in its manufacturing suite in Reykjavik, Iceland. The new process more than doubles drug substance output per batch without changing the upstream manufacturing scale. 



  Alvotech said the improvement was achieved through targeted process development, effective process transfer and successful process validation, with demonstrated comparability to the previously approved process, maintaining product quality, safety and efficacy. 





  Write to Chris Wack at chris.wack@wsj.com 





  (END) Dow Jones Newswires



  October 20, 2026 10:00 ET (14:00 GMT)


Copyright (c) 2026 Dow Jones & Company, Inc.
  

					The articles, information, and content displayed on this webpage may
					include materials prepared and provided by third parties. Such
					third-party content is offered for informational purposes only and
					is not endorsed, reviewed, or verified by Morningstar.
				
 

					Morningstar makes no representations or warranties regarding the
					accuracy, completeness, timeliness, or reliability of any third-party
					content displayed on this site. The views and opinions expressed in
					third-party content are those of the respective authors and do not
					necessarily reflect the views of Morningstar, its affiliates, or employees.
				
 

					Morningstar is not responsible for any errors, omissions, or delays
					in this content, nor for any actions taken in reliance thereon.
					Users are advised to exercise their own judgment and seek independent
					financial advice before making any decisions based on such content.
					The third-party providers of this content are not affiliated with
					Morningstar, and their inclusion on this site does not imply any
					form of partnership, agency, or endorsement.
				
 

				Popular
				
 
  
 
 
 
 
4 Stocks to Buy for the Long-Term While They’re Still Undervalued
 
Plus, a deep dive on SpaceX’s bid to challenge US telecoms. 
 
 
David Sekera, CFA and Sarah Hansen 
 
 
 
Are TIPS ETFs the Best Way to Fight Inflation?
 
Plus, four TIPS ETFs with top marks from Morningstar, and what you need to know before investing. 
 
 
Daniel Sotiroff and Ivanna Hampton 
 
 
 
6 ETFs To Diversify Away From AI
 
A difficult problem has an easy solution. 
 
 
Daniel Sotiroff 
 
 
 
What’s Ahead for Stocks This Quarter—and Where to Invest
 
Morningstar’s chief market strategist and economist share their outlooks for the fourth quarter of 2026. 
 
 
David Sekera, CFA, Preston Caldwell, and Susan Dziubinski 
 
 
 
10 Best Blue-Chip Stocks to Buy for the Long Term
 
The stocks of these high-quality companies look cheap today. 
 
 
Tori Brovet 
 
 
 
 

			Sponsor Center