Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced the U.S. Food and Drug Administration (FDA) has approved the citrate-free, high-concentration (100 mg/mL) formulation of HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab). HADLIMA will be available in pre-filled syringe and autoinjector options, and the autoinjector was specifically designed with the patient in mind. HADLIMA was previously approved by the FDA as a low-concentration (50 mg/mL) formulation in July 2019 and outside the US that formulation has been available in various markets globally under different brand names, with over 5 million doses sold since 2018.1,2
Samsung Bioepis and Organon Announce FDA Approval of Citrate-Free High-Concentration HUMIRA® Biosimilar HADLIMA™ (adalimumab-bwwd)
Aug 17, 2022
Research Tools
All-In-One Screener
Stock Ideas
Stock List
Guru List
Guru Real-Time Picks
Insider List
Insider Trades
Economic Indicators
Sector & Industry Performance
DCF Calculator
Discussion Board
Product
Pricing Plans
Excel Add-In
Google Sheets Add-on
Data API
Stock Comparison Table
Manual of Stocks
Mobile App
中文
Education
Financial Glossary
Tutorials
FAQ
Schedule Free Session
Buffett Indicator
Shiller P/E
Yield Curve Today
U.S. Inflation Rate
Global Market Valuation
Fed Net Liquidity
Buffett Assets Allocation
Company
About GuruFocus
Career
Contact Us
ETF
Advertise
Site Map
Term of Use
Privacy Policy
Referral Program
Partner Program
Survey
We'd love to learn more about your experiences on GuruFocus.com and how we can improve!
Take Survey
Follow Us
Disclaimers
GuruFocus.com is not operated by a broker or a dealer. It has an affiliated registered investment adviser, which serves as the subadviser to an exchange traded fund. This investment adviser does not provide advice to individual investors. Under no circumstances does any information posted on GuruFocus.com represent a recommendation to buy or sell a security. The information on this site, and in its related newsletters, is not intended to be, nor does it constitute investment advice or recommendations. The individuals or entities selected as "gurus" may buy and sell securities before and after any particular article and report and information herein is published, with respect to the securities discussed in any article and report posted herein. Gurus may be added or dropped from the GuruFocus site at any time. In no event shall GuruFocus.com be liable to any member, guest or third party for any damages of any kind arising out of the use of any content or other material published or available on GuruFocus.com, or relating to the use of, or inability to use, GuruFocus.com or any content, including, without limitation, any investment losses, lost profits, lost opportunity, special, incidental, indirect, consequential or punitive damages. Past performance is a poor indicator of future performance. The information on this site, and in its related newsletters, is not intended to be, nor does it constitute investment advice or recommendations. The information on this site is in no way guaranteed for completeness, accuracy or in any other way. The gurus listed in this website are not affiliated with GuruFocus.com, LLC. Stock quotes are provided by QuoteMedia, Inc. (CSI). Company fundamental data is provided by Morningstar. Analyst estimates data is sourced from both Refinitiv and Morningstar, with priority given to Refinitiv data. Data is updated daily.
© 2004-2024 GuruFocus.com, LLC. All Rights Reserved.