Bringing important medicines to patients in need. Download now See Note 3 to the Condensed Consolidated . A biosimilar must show that it is has no clinically meaningful differences in safety, purity and potency compared with the reference biologic. Updated July 18, 2018. We prioritize our patients first through listening, learning and understanding their needs. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. We build upon our strong foundation of more than 60 medicines and other products across a range of areas including reproductive health, heart disease, dermatology, allergies and asthma. For institutions Organon will market Renflexis, an infliximab biosimilar, Ontruzant (trastuzumab), Aybintio (bevacizumab), and Hadlima (adalimumab). Any statements set forth on this website that are not historical facts are considered forward-looking statements within the meaning of the safe harbor provisions of the U.S. 1-844-820-5468 Although these statements are based on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and you should not place undue reliance on them. July 2018. ET. organon announced the launch and product availability of aybintio, a biosimilar of avastin, providing a new treatment option for adult canadian patients affected with certain aggressive forms of cancers, including metastatic colorectal cancer (mcrc), locally advanced, metastatic or recurrent non-small cell lung cancer (nsclc), Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. With over 20 years of commercial experience in bio-pharmaceutical organizations and digital therapeutics, Ms. Rivera will be responsible for leading Organon's 400-strong US Commercial Operations team, maximizing growth potential across the company's portfolio of women's health, biosimilars, and established brands treatment areas. We know women need more choices when it comes to their healthcare. jersey city, n.j.-- (business wire)-- organon (nyse: ogn), a global women's health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with shanghai henlius biotech, inc. (2696.hk), whereby organon will license commercialization rights for biosimilar candidates referencing perjeta 4 Biologics are the fastest-growing class . Our goal is to design our portfolio to help address her needs, our goal is to create a better and healthier every day, for every woman. In addition, the company will focus on its biosimilars portfolio in oncology and inflammatory diseases, whilst also maximising the value of its trusted dermatology, pain, respiratory . For the quarter, jersey city, n.j.-- ( business wire )--organon (nyse: ogn), a global women's health company with deep expertise in biosimilar commercialization, today announced that it has entered into an. We seek collaborations that add products and are synergistic with our infrastructure and capabilities. Key business development contacts Daniel Karp During the spinoff, Organon assumed Merck's biosimilars portfolio and women's health brand products, along with various other established brands. We are motivated by a womans evolving health needs throughout her lifetime. Accessed April 5, 2021. https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-biosimilar-product-labeling. Organon will sell these biosimilars in partnership with Samsung Bioepis of Republic of Korea. Doctors use biologic medicines to treat a range of serious conditions. "We continue to build. Biosimilars provide more options for patients across a range of therapeutic areas. Organon, a proposed spinoff of Merck's women's health, biosimilars and established brands businesses, intends to appoint a majority-female board of directors. US Food and Drug Administration. Careers Adopting biosimilars can be complicated. The company began life saddled with ~$9.4bn of debt versus annual revenue generation of ~$6.5bn.. The following biosimilar products are part of a development and commercialization agreement between Organon and Samsung Bioepis entered into in 2013. Before getting into biosimilars, it helps to know about biologics. Download now HCP clinical brochure A helpful guide that provides important considerations when choosing to utilize ONTRUZANT. Organon Biosimilars is a focused team at Organon, here to help provide information and resources to help you reach your biosimilar goals. In 2022, Viatris sold the company's only growing product portfolio for $3.335 billion to Biocon Biologics.. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the companys ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the companys patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. Regular hours of operation: Monday Friday 8:00 a.m. 7:00 p.m. Our mission is to deliver impactful medicines and solutions for a healthier every day. This news release of Organon (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. The contents of this site, including but not limited to Organon Canada product information and product monographs, are intended solely for residents of Canada. Our three pillarswomens health, biosimilars and established medicines are the foundation for how we strive to achieve our vision to create a better and healthier every day. Biosimilars action plan: balancing innovation and competition. "On June 3 rd , Organon will launch as a new company, with solid growth opportunities and the ability to make an impact in women's health," said Kevin Ali, Organon's chief executive officer. US Department of Health and Human Services (HHS) is taking steps to help address the challenges of access to and reimbursement of biosimilars, such as 10: Improving billing and payment code policies under Medicare Part B Revising Medicare Part C and D regulations to help increase access to biosimilars FDA's Biosimilars Action Plan 8 Thats why our intention is to take on some of the issues that matter most to her. By their nature, forward-looking statements involve risks and uncertainties because they depend on circumstances that may or may not occur in the future. References: 1. Although these statements are based on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and you should not place undue reliance on them. Organon biosimilar portfolio sales were $99 million in Q1 2022, up 22.2% from Q1 2021. JERSEY CITY, N.J., November 03, 2022 -- ( BUSINESS WIRE )--Organon (NYSE: OGN) (the "company"), today announced its results for the third quarter ended September 30, 2022. Aybintio was developed and manufactured by Organon's collaborator Samsung Bioepis which also developed and manufactured its other biosimilars portfolio including Hadlima , Brenzys and. Private Securities Litigation Reform Act of 1995. Adopting biosimilars can be complicated. Organon is based in Jersey City, New Jersey, and has a portfolio of more than 60 medicines and therapeutic products. The product websites presented here are intended for use in the United States, its territories and Puerto Rico only. By providing access to biosimilars as an important treatment option, we aim to bring more choices to more patients who need them. View all locations and contact information. As the biosimilar landscape changes, so do wewith an unwavering commitment to dedicated support. Led by the women's health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon's products produce strong cash flows that will support investments in innovation and future growth opportunities in women's health. Helpful information from the FDA explaining what a biosimilar is. ET. jersey city, n.j.- june 13, 2022 - organon (nyse: ogn), a global women's health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with shanghai henlius biotech, inc. (2696.hk), whereby organon will license commercialization rights for biosimilar candidates referencing perjeta Contact Organon Service Center Report an adverse event 844-674-3200 Service_Center@Organon.com You can call this number 24/7 for any product-related emergency. By their nature, forward-looking statements involve risks and uncertainties because they depend on circumstances that may or may not occur in the future. US Food and Drug Administration. We prioritize putting our patients first through listening, learning and understanding their needs. July 2018. A lot of medicines that you pick up at your local drug store are made of fairly simple molecules, whereas biologic medicines have extremely complex molecules. Organon will not be involved in the research side of drug development. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. On August 4th, 2022, Organon reported second quarter results for the period ending June 30th, 2022. The spinoff has resulted in 15% of revenue, 25% of manufacturing sites and 50% of products being transferred from Merck to Organon. With over 20 years of commercial experience in bio-pharmaceutical organizations and digital therapeutics, Ms. Rivera will be responsible for leading Organon's 400-strong US Commercial Operations team, maximizing growth potential across the company's portfolio of women's health, biosimilars, and established brands treatment areas. You can call this number 24/7 for any product-related emergency. Any statements set forth on this website that are not historical facts are considered forward-looking statements within the meaning of the safe harbor provisions of the U.S. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys other filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SECs Internet site (www.sec.gov). As with generics, biosimilars are designed to be similar to another medicine. If you are a resident of a country other than the United States, please see our worldwide locations to find information about our offices around the globe. Accessed April 5, 2021. https://www.fda.gov/media/114574/download, https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-biosimilar-product-labeling. The Biosimilars Forum includes Biogen, Boehringer Ingelheim, Coherus BioSciences, Pfizer, Samsung Bioepis, Sandoz, Teva, and Viatris. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys other filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SECs Internet site (www.sec.gov). Bringing medicines to patients in need Biosimilars were introduced with the goal of offering patients more treatment options and reducing healthcare costs related to biologics. Connect to medical information services anytime via AskOrganon, View all locations and contact information. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Merck is also handing its trastuzumab (Ontruzant) biosimilar franchise over to Organon. Biosimilar Resources Find videos and downloadable resources below that may be helpful to you, your colleagues, and your patients as you move toward using biosimilars in your institution All Assets Biosimilars Education FDAWhat Is a Biosimilar? https://bit.ly/3Ha2tl2 Jersey City, NJ, USAorganonbiosimilars.comJoined October 2020 23Following 345Followers Tweets Tweets & replies Media Likes Organon Biosimilars's Tweets The company assumes no duty to update the information to reflect subsequent developments. The new company formed, Organon, is positioning itself as "the only player of its size (USD 6.3 billion in revenues for 2021, 9,000 employees) focused on women's health at every stage of life." Our hope is to give people more choice throughout their lives. You are now leaving OrganonBiosimilars.com. At Organon, we are focused on her future. US Food and Drug Administration. Accessed April 5, 2021. https://www.fda.gov/media/114574/download 2. Any statements set forth on this website that are not historical facts are considered forward-looking statements within the meaning of the safe harbor provisions of the U.S. We share womens stories to amplify her voice and inspire change. As the biosimilar landscape changes, so do we with an unwavering commitment to providing more options for patients. Collaboration expands and underscores commitment to biosimilars portfolio and focus on women's health with biosimilar candidates for osteoporosis and breast cancer Organon (NYSE: OGN), a global women's health company with deep expertise in biosimilar commercialization, today announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will . As the healthcare landscape changes, so do we. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys other filings with the Securities and Exchange Commission (SEC), including its registration statement on Form 10, available at the SECs Internet site (www.sec.gov). ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. Because we know there is much more to be done, we will listen to her needs to drive our product development decisions. ET Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Bringing important medicines to patients in need. If you are a consumer or patient and have any questions regarding your therapy or require more detailed information about one of our products, we recommend you contact your physician, pharmacist, nurse or other qualified healthcare professional, as we cannot provide medical advice to patients. The company also has a small portfolio of biosimilars which are used in immunology and oncology. Sandra Levy Senior Editor We aim to empower women to make the right health choices for them with an ambition to help women achieve their family goals. Organon, a Merck spinoff that officially started life in June 2021, reported $140 million in biosimilars revenue for the just-ended quarter, up 41% from the comparable 2020 third quarter. Biosimilars By providing access to biosimilars as an important treatment option, we aim to bring more choices to more patients who need them. Regular hours of operation: Monday - Friday 8:00 a.m. - 7:00 p.m. Our portfolio of established medicines has a long history across a range of therapeutic areas. Highlights of the sales of Organon's products for the three and nine months ended September 30, . There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. US Food and Drug Administration. One-minute video for health care professionals that covers the rigorous biosimilar approval process. For information about or to provide feedback on Organon Canadas products and services, including the reporting of an Adverse Event or Product Quality Complaint with a specific Organon Canada product, please call our Medical Information Centre. Private Securities Litigation Reform Act of 1995. Trademarks appearing on this website are owned, licensed to, promoted or distributed by Organon, its subsidiaries or affiliates, except as noted. These statements are based upon the current beliefs and expectations of Organons management and are subject to significant risks and uncertainties. Our portfolio of established medicines has a long history and covers critical areas including cardiovascular, respiratory, dermatology and non-opioid pain management and more. We work to provide medicines and other products that help address a wide array of conditions and diseases that women and their loved ones face. Accessed April 5, 2021. Private Securities Litigation Reform Act of 1995. We envision a better and healthier every day for every woman. At launch, Organon's portfolio will consist of more than 60 medicines and products across its three core franchises: Women's Health, Biosimilars and Established Brands. And we bring these important therapies around the world, with an international footprint that serves people in more than 140 markets. jersey city, n.j., june 13, 2022 -- ( business wire )--organon (nyse: ogn), a global women's health company with deep expertise in biosimilar commercialization, today announced that it has. Through our portfolio of products specifically designed to address her needs, our goal is to create a better and healthier every day, for every woman. We know women need more choices when it comes to their healthcare. 2022 Organon group of companies. Organon's Products: Biosimilars AYBINTIO Product Monograph Consumer Information Aybintio was developed and manufactured by Organon's collaborator Samsung Bioepis which also developed and manufactured its other biosimilars portfolio including Hadlima , Brenzys and Renflexis . Other countries may have different regulatory requirements and review practices that may require referencing different information. Biosimilars are approved by the FDA as being highly similar to an already approved biologic medicine. 1-450-366-1750 medinfocanada@organon.comHours of operationMonday Friday 8:30 a.m. 4:30 p.m. That is why we prioritize our customers first through listening, learning, and understanding their needs. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Organon Biosimilars @organonbiosim Organon Biosimilars is a focused team at Organon, here to provide information and resources to help you reach your biosimilar goals. These statements are based upon the current beliefs and expectations of Organons management and are subject to significant risks and uncertainties. With over 20 years of commercial experience in bio-pharmaceutical organizations and digital therapeutics, Ms. Rivera will be responsible for leading Organon's 400-strong US Commercial Operations team, maximizing growth potential across the company's portfolio of women's health, biosimilars, and established brands treatment areas. From our perspective: biosimilar product labeling. Private Securities Litigation Reform Act of 1995. Visit Organon Biosimilars website The Organon Access Program info sheet A handy resource with quick-hit information to help your practice easily and efficiently utilize the tools of The Organon Access Program. US-NON-110228 01/22. We at Organon Biosimilars believe your experience matters. Biosimilars were introduced with the goal of offering patients more treatment options and reducing healthcare costs related to biologics. Established medicines Our portfolio of established medicines has a long history and covers critical areas including cardiovascular, respiratory, dermatology and non-opioid pain management and more. kirkland, qc, nov. 7, 2022 /cnw/ - organon (nyse: ogn), a global women's health company, is announcing the launch and product availability of aybintio , a biosimilar of avastin , providing a. Biosimilars were introduced with the goal of offering patients more treatment options and reducing healthcare costs related to biologics. Download these resources for help navigating considerations along the biosimilar adoption process at both the institutional and private practice level. In June 2021, as part of a broader restructuring, Merck (MSD globally) spun off its women's health, legacy products, and biosimilars businesses. Through the adoption of biosimilars, it is estimated that the health care system could save $104 billion from 2020 to 2024. They are made from living organisms, like bacteria or yeast. For United States, its territories, and Puerto Rico only. Organon, a Merck spinoff that officially started life in June 2021, reported $140 million in biosimilars revenue for the just-ended quarter, up 41% from the comparable 2020 third quarter. No Duty to Update Biosimilars action plan: balancing innovation and competition. Established brands Organon has a global footprint and broad portfolio of 49 established brands, including products in cardiovascular, respiratory, dermatology and non-opioid pain management. These statements are based upon the current beliefs and expectations of Organons management and are subject to significant risks and uncertainties. The company also plans to market the etanercept biosimilar Brenzys. Thus the name, biosimilar. For information about Organons products and services in the U.S., including the reporting of an Adverse Event or Product Quality Complaint with a specific Organon product, please call the Organon Service Center. Although these statements are based on assumptions that we believe are reasonable when made, we caution you that forward-looking statements are not guarantees of future performance and you should not place undue reliance on them. Organon's operations include a portfolio of products. Keep up to date on all things Organon by checking out our latest news. We believe that by listening to women, and focusing on research and innovations that address their unmet healthcare needs, we are working to help realize a future as unlimited as her imagination. View all locations and contact information. Our people a global community of thousands strong are united in our drive to better support the health of women within our company and around the globe. Download in English Download in Spanish Some people think a biosimilar is like a generic medicine. Biosimilars are a type of biologic medicine. All rights reserved. We invest in innovations to support the distinct healthcare needs of women today and provide value for our shareholders.

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