View all locations and contact information. Private Securities Litigation Reform Act of 1995. Biosimilars were introduced with the goal of offering patients more treatment options and reducing healthcare costs related to biologics. Other countries may have different regulatory requirements and review practices that may require referencing different information. Doctors use biologic medicines to treat a range of serious conditions. As with generics, biosimilars are designed to be similar to another medicine. On August 4th, 2022, Organon reported second quarter results for the period ending June 30th, 2022. View all locations and contact information. Highlights of the sales of Organon's products for the three and nine months ended September 30, . Merck is also handing its trastuzumab (Ontruzant) biosimilar franchise over to Organon. 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. Thats why our intention is to take on some of the issues that matter most to her. 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. The company began life saddled with ~$9.4bn of debt versus annual revenue generation of ~$6.5bn.. For the quarter, Our mission is to deliver impactful medicines and solutions for a healthier every day. Organon's Products: Biosimilars AYBINTIO Product Monograph Consumer Information The spinoff has resulted in 15% of revenue, 25% of manufacturing sites and 50% of products being transferred from Merck to Organon. They are made from living organisms, like bacteria or yeast. Private Securities Litigation Reform Act of 1995. And we bring these important therapies around the world, with an international footprint that serves people in more than 140 markets. 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 . Accessed April 5, 2021. 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. 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). The company also has a small portfolio of biosimilars which are used in immunology and oncology. Helpful information from the FDA explaining what a biosimilar is. 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). No Duty to Update By their nature, forward-looking statements involve risks and uncertainties because they depend on circumstances that may or may not occur in the future. Careers US Food and Drug Administration. "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. Organon will market Renflexis, an infliximab biosimilar, Ontruzant (trastuzumab), Aybintio (bevacizumab), and Hadlima (adalimumab). 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). Your healthcare professional is the best source of information regarding your health. About Us Our approach We at Organon Biosimilars believe your experience matters. Private Securities Litigation Reform Act of 1995. Biosimilars action plan: balancing innovation and competition. Download in English Download in Spanish 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. 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. We prioritize putting our patients first through listening, learning and understanding their needs. Connect to medical information services anytime via AskOrganon, View all locations and contact information. One-minute video for health care professionals that covers the rigorous biosimilar approval process. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon is based in Jersey City, New Jersey, and has a portfolio of more than 60 medicines and therapeutic products. Our portfolio of established medicines has a long history and covers critical areas including cardiovascular, respiratory, dermatology and non-opioid pain management and more. These statements are based upon the current beliefs and expectations of Organons management and are subject to significant risks and uncertainties. Bringing important medicines to patients in need. We aim to empower women to make the right health choices for them with an ambition to help women achieve their family goals. We share womens stories to amplify her voice and inspire change. References: 1. Through the adoption of biosimilars, it is estimated that the health care system could save $104 billion from 2020 to 2024. You can call this number 24/7 for any product-related emergency. 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), Our portfolio of established medicines has a long history across a range of therapeutic areas. ET. Biosimilars are a type of biologic medicine. "We continue to build. By their nature, forward-looking statements involve risks and uncertainties because they depend on circumstances that may or may not occur in the future. From our perspective: biosimilar product labeling. Aybintio was developed and manufactured by Organon's collaborator Samsung Bioepis which also developed and manufactured its other biosimilars portfolio including Hadlima , Brenzys and. Adopting biosimilars can be complicated. As the biosimilar landscape changes, so do we with an unwavering commitment to providing more options for patients. One of the goals in introducing biosimilars was reducing health care costs related to biologics.1,2 Learn more about what biosimilars may offer the health care system. US Food and Drug Administration. 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. As the healthcare landscape changes, so do we. If you are a resident of a country other than Canada, please see our worldwide locations to find information about our offices around the globe. 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." We invest in innovations to support the distinct healthcare needs of women today and provide value for our shareholders. 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. Deciding, implementing, and monitoring the adoption of a biosimilar can seem daunting, but Organon Biosimilars is here to help you identify the various steps involved. 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 By providing access to biosimilars as an important treatment option, we aim to bring more choices to more patients who need them. 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? The company will start life with an estimated $6.5 billion in annual revenue, 80% of that derived from sales outside the United States. 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. 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. This news release of Organon (the company) includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Organon Biosimilars is a focused team at Organon, here to help provide information and resources to help you reach your biosimilar goals. Biosimilars action plan: balancing innovation and competition. 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. What is a biosimilar? Bringing important medicines to patients in need. All rights reserved. Organon's portfolio will be led by the Nexplanon/Implanon contraceptive implant, which saw sales decline by 14% in 2020 to $680 million, mainly due to women delaying or canceling elective. 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. Download these resources for help navigating considerations along the biosimilar adoption process at both the institutional and private practice level. Organon will sell these biosimilars in partnership with Samsung Bioepis of Republic of Korea. Through the adoption of biosimilars, it is estimated that the health care system could save $104 billion from 2020 to 2024. 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. 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. These statements are based upon the current beliefs and expectations of Organons management and are subject to significant risks and uncertainties. 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. https://bit.ly/3Ha2tl2 Jersey City, NJ, USAorganonbiosimilars.comJoined October 2020 23Following 345Followers Tweets Tweets & replies Media Likes Organon Biosimilars's Tweets You are now leaving OrganonBiosimilars.com. Some people think a biosimilar is like a generic medicine. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. We prioritize our patients first through listening, learning and understanding their needs. Sandra Levy Senior Editor 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 . Our established brands include well-known products across a range of therapeutic areas like respiratory, cardiovascular, dermatology, non-opioid pain and more. We envision a better and healthier every day for every woman. Regular hours of operation: Monday - Friday 8:00 a.m. - 7:00 p.m. Biosimilars provide more options for patients across a range of therapeutic areas. Download now HCP clinical brochure A helpful guide that provides important considerations when choosing to utilize ONTRUZANT. Our hope is to give people more choice throughout their lives. A biosimilar is a biologic product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Trademarks appearing on this website are owned, licensed to, promoted or distributed by Organon, its subsidiaries or affiliates, except as noted. As the biosimilar landscape changes, so do wewith an unwavering commitment to dedicated support. The product websites presented here are intended for use in the United States, its territories and Puerto Rico only. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the companys 2020 Annual Report on Form 10-K and the companys other filings with the Securities and Exchange Commission (SEC) available at the SECs Internet site (www.sec.gov). US Food and Drug Administration. In June 2021, as part of a broader restructuring, Merck (MSD globally) spun off its women's health, legacy products, and biosimilars businesses. Key business development contacts Daniel Karp For United States, its territories, and Puerto Rico only. The Biosimilars Forum includes Biogen, Boehringer Ingelheim, Coherus BioSciences, Pfizer, Samsung Bioepis, Sandoz, Teva, and Viatris. At Organon, we are focused on her future. For institutions Regular hours of operation: Monday Friday 8:00 a.m. 7:00 p.m. 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. Biosimilars provide more options for patients across a range of therapeutic areas. By their nature, forward-looking statements involve risks and uncertainties because they depend on circumstances that may or may not occur in the future. Biosimilars By providing access to biosimilars as an important treatment option, we aim to bring more choices to more patients who need them. 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. Because we know there is much more to be done, we will listen to her needs to drive our product development decisions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. 1-450-366-1750 medinfocanada@organon.comHours of operationMonday Friday 8:30 a.m. 4:30 p.m. Organon Biosimilars is a focused team at Organon, here to help provide information and resources to help you reach your biosimilar goals. 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 See Note 3 to the Condensed Consolidated . Adopting biosimilars can be complicated. Updated July 18, 2018. 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. Helpful information from the FDA explaining what a biosimilar is. Thus the name, biosimilar. 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. From our perspective: biosimilar product labeling. A biosimilar must show that it is has no clinically meaningful differences in safety, purity and potency compared with the reference biologic. View all locations and contact information. Accessed April 5, 2021. https://www.fda.gov/drugs/news-events-human-drugs/our-perspective-biosimilar-product-labeling. These statements are based upon the current beliefs and expectations of the companys management and are subject to significant risks and uncertainties. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. 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