SHANGHAI, China & JERSEY CITY, NJ – SEPTEMBER 19 , 2025 – Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for BILDYOS ® (denosumab) injection 60 mg/mL and BILPREVDA ® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. 1,2 “The EC approvals of BILDYOS and BILPREVDA mark a pivotal moment in expanding access to essential bone care treatments for millions of Europeans, particularly women, who are disproportionately affected by osteoporosis,” said Nico Van Hoecke, Head, International Commercial at Organon. 3,4 “These biosimilars may offer additional treatment options across several therapeutic areas associated with bone loss, including osteoporosis, and reflect Organon’s commitment to advancing women’s health through access to important medicines. 4 These approvals,
https://www.organon.com/news/european-commission-ec-approves-henlius-and-organons-bildyos-denosumab-and-bilprevda-denosumab-biosimilars-to-prolia-denosumab-and-xgeva-denosumab-respectively/
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS ® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA ® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. 1,2 “The FDA approvals of BILDYOS and BILPREVDA mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the US, including a growing aging population. 3,4,5 Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women,” said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon. 3,4 “This approval underscores Organon’s unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of
https://www.organon.com/news/us-food-and-drug-administration-fda-approves-henlius-and-organons-bildyos-denosumab-nxxp-and-bilprevda-denosumab-nxxp-biosimilars-to-prolia-denosumab-and-xgeva-denosumab/
Second quarter 2025 revenue of $1.594 billion Second quarter 2025 diluted earnings per share of $0.56 and non-GAAP Adjusted diluted earnings per share of $1.00; GAAP diluted earnings per share includes a $46 million gain, or $0.14 per share, for early extinguishment of debt Second quarter 2025 net income of $145 million and Adjusted EBITDA (non-GAAP) of $522 million, representing an Adjusted EBITDA margin of 32.7% The company repaid $345 million of long-term debt during the quarter; on track to achieve a net debt to Adjusted EBITDA ratio of less than 4.0x by year-end Revenue guidance range for full year 2025 raised to $6.275 billion to $6.375 billion based on the company’s current views of foreign exchange; guidance range for Adjusted EBITDA margin (non-GAAP) affirmed at 31.0% to 32.0% Organon (NYSE: OGN) today announced its results for the second quarter ended June 30, 2025. “During the quarter we paid down principal on our long-term debt and began implementing meaningful cost
https://www.organon.com/news/organon-reports-results-for-the-second-quarter-ended-june-30-2025/
The American Academy of Dermatology (AAD) provides a strong evidence-based recommendation for the use of VTAMA cream in adults with moderate to severe atopic dermatitis (AD), the most common form of eczema. Recommendation reflects VTAMA cream’s proven efficacy, safety, and tolerability as a steroid-free, topical aryl hydrocarbon receptor agonist. AD impacts 26 million people in the United States, 16.5 million of which are adults. Organon (NYSE: OGN), a global independent healthcare company with a focus on women’s health, today announced that VTAMA ® (tapinarof) cream, 1%, was granted a strong recommendation by the American Academy of Dermatology (AAD) in their 2025 focused guideline update for the management of adults with moderate to severe atopic dermatitis (AD). The recommendation underscores VTAMA cream as an effective, steroid-free option for daily disease management, with no label warnings or precautions, no contraindications, and no restrictions on duration of use or percentage
https://www.organon.com/news/organons-vtama-tapinarof-cream-1-granted-strong-recommendation-in-the-american-academy-of-dermatology-updated-2025-guidelines-for-adult-atopic-dermatitis/
HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab)1,2 The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis3 An interchangeable biosimilar product may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws4 Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira ® (adalimumab). 2 These interchangeability designations follow the interchangeability
https://www.organon.com/news/us-food-and-drug-administration-fda-grants-interchangeability-designation-to-samsung-bioepis-and-organon-hadlima-adalimumab-bwwd-injection/
Company affirms full year 2025 financial guidance, resets dividend payout to strengthen capital structure Guidance ranges for full year 2025 revenue and Adjusted EBITDA margin are affirmed; company expects to generate over $900 million of free cash flow before one-time costs in 2025 Vtama on track to achieve $150 million revenue target for full year 2025; double-digit growth in Nexplanon in the first quarter Company resets capital allocation priorities to accelerate progress towards deleveraging; new annual regular dividend rate of $0.08 per share First quarter 2025 revenue of $1.513 billion, down 7% as-reported and down 4% at constant currency, consistent with company’s expectations First quarter 2025 diluted earnings per share of $0.33 and non-GAAP Adjusted diluted earnings per share of $1.02 First quarter 2025 net income of $87 million and Adjusted EBITDA (non-GAAP) of $484 million, representing an Adjusted EBITDA margin of 32.0% Organon (NYSE: OGN) today announced its results for
https://www.organon.com/news/organon-reports-results-for-the-first-quarter-ended-march-31-2025/
From personal experiences to professional passion Rania Haggag’s journey into pharmacovigilance did not start in a classroom or office. It began at home, witnessing her mother’s struggle with rheumatoid arthritis (RA). Her journey, particularly with the various medicines to treat the condition, left a lasting impression on Rania. “My passion for this field was ignited […]
https://www.organon.com/stories/reshaping-healthcare-for-women-globally/
The acquisition expands Organon’s dermatology capabilities with a nonbiologic, non-steroidal topical treatment in the U.S. Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, today announced the successful completion of its acquisition of Dermavant Sciences Ltd. from Roivant (NASDAQ: ROIV). Dermavant is a company dedicated to developing and commercializing innovative therapeutic solutions in immuno-dermatology. Please see our prior announcement for a summary of the transaction terms . VTAMA ® (tapinarof) cream, 1%, is a novel nonbiologic, non-steroidal topical therapy approved by the U.S. Food and Drug Administration (FDA) for treatment of mild, moderate, and severe plaque psoriasis in adults with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental New Drug Application (sNDA) for VTAMA cream as a potential treatment
https://www.organon.com/news/organon-completes-acquisition-of-dermavant-including-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/
VTAMA cream is a novel, non-steroidal topical therapy approved for treatment of plaque psoriasis in adults and is under FDA review for an additional indication to treat atopic dermatitis Proposed acquisition extends Organon’s international dermatology capabilities to the U.S. JERSEY CITY, N.J., September 18, 2024 – Organon (NYSE: OGN), a global healthcare company with a mission to improve the health of women throughout their lives, and Dermavant Sciences Ltd. announced today that they have entered into a definitive agreement, under which Organon will acquire Dermavant, a Roivant (NASDAQ: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s novel product, VTAMA® (tapinarof) cream, 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the U.S. Food and Drug Administration (FDA) in May 2022. VTAMA cream is a once-daily, steroid-free, topical applied to affected areas with no
https://www.organon.com/news/organon-to-acquire-dermavant-including-its-innovative-dermatologic-therapy-vtama-tapinarof-cream-1/
We share her stories to amplify her voice and inspire our work
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