Our diverse range of generic and complex generic medicines work in the same way and provide the same clinical benefits as their brand-name counterparts and help increase access for patients. PITTSBURGH, Nov. 7, 2022 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) today reported strong results for the third quarter of 2022 and reaffirmed its 2022 financial guidance. goal is our focus on biosimilar medicines. In February, Viatris announced it had agreed to sell its biosimilars business to Biocon Biologics for $3.3 billion. The aflibercept biosimilar candidate is on the cusp of FDA regulatory submission, and this is scheduled for the fourth quarter of 2021, according to Rajiv Malik, president of Viatris. The underappreciated stock has a deep pipeline. And they're all in different clinical trial stages at this time, from preclinical to phase 3. By 2028, at least $500 million in adjusted EBITDA. The new company brings together Mylan's diverse portfolio across many geographies and key therapeutic areas and its robust pipeline, high-quality manufacturing, and supply chain excellence with Upjohn's trusted brands and proven commercialization capabilities, including leadership positions in China and other emerging markets. Semglee is not the only [product] in our pipeline this quarter. MYLAN, INC. AND BIOSIMILARS WITHOUT BORDERS ARE NOT IN ANY WAY AFFILIATED WITH DOCTORS WITHOUT BORDERS OR MDECINS SANS FRONTIRES. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them. Bio-Thera Solutions, Ltd.: Sandoz entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for the proposed biosimilar bevacizumab (BAT1706).Bio-Thera Solutions, Ltd. will maintain responsibility for development and manufacturing, Sandoz will have the right to commercialize the medicine upon approval in the US, Europe, Canada and selected other countries. Viatris has provided an update on its biosimilar pipeline, covering assets including insulin glargine, insulin aspart, aflibercept and bevacizumab, as part of its second quarter strategic update. Viatris Tipped To Knock Out Crucial Eylea Dosing Patents In US As a trusted partner of choice, were dedicated to collaborating with you to address healthcare system complexities through a unique platform that helps ensure greater patient access to quality medicines worldwide. As a result, protecting patients and consumer health by ensuring the quality and safety of our products is at the heart of how we operate across our network. We consider it our duty to advocate for policies that advance knowledge and education, reduce barriers to treatment access to achieve better health for patients and unlock value for health systems. Some examples of our capabilities include: The information contained on this page is not for use in product detailing or promotion. The company announced last month that it would sell its biosimilars business - one. pittsburgh, nov. 7, 2022 /prnewswire/ -- viatris inc. (nasdaq: vtrs), a global healthcare company, today announced that it intends to create an ophthalmology franchise by acquiring oyster point. Notably, we have paid down approximately $2.1 billion in debt year-to-date in 2022 and approximately $4.2 billion since the beginning of 2021, putting us squarely on track for our target to pay . Viatris remains hopeful of obtaining FDA approval for its proposed biosimilar to Botox in partnership with Revance Therapeutics in 2026, . Biologic medicines have Humira (adalimumab) biosimilars pipeline Immunology To be determined AVT02 (Teva/Alvotech) *pending approval TBD* California Supply Chain Transparency, UK and Australia Modern Slavery Statement. Were committed to increasing patient access to quality, affordable medicines, regardless of geography or circumstance. Viatris has another insulin glargine product in preclinical development (referencing Toujeo; Sanofi), as well as an onabotulinumtoxin biosimilar (referencing Botox) in preclinical stage development. Finally, there are about 5 rapid-acting insulin biosimilars currently in the pipeline for manufacturers including Biocon, Viatris, Sandoz, and Sanofi. We offer one of the industrys largest and most diverse global biosimilars franchises focused on the areas of oncology, immunology, endocrinology, ophthalmology and dermatology. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology and other non-communicable diseases. Viatris is committed to helping patients address their evolving healthcare needs by increasing access to affordable, quality medicines. VIATRIS and the Viatris Logo are trademarks and GLOBAL HEALTHCARE GATEWAY, PARTNER OF CHOICE and the Global Healthcare Gateway logo are registered trademarks of Mylan Inc., a Viatris company. Discover how our diverse and differentiated portfolio across a broad range of therapeutic areas contributes to our mission of empowering people to live healthier at every stage of life. Links to Viatris affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. We deliver proven,best-in-class, medicines, including treatments for 9 out of 10 of the World Health Organizations leading causes of death. for many serious diseases. The companys etanercept product was launched in the European Union in 2020. Links to Viatris affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Viatris' products from Pfizer include the erectile dysfunction aid Viagra (sildenafil) and cholesterol management drug Lipitor (atorvastatin); and from Mylan, Viatris gains the epinephrine auto-injector EpiPen. Biocon Biologics to Acquire Viatris' Biosimilars Assets for up to USD 3.335 billion in Stock and Cash Details: BBL will have a comprehensive portfolio comprising its current range of commercialized insulins, oncology and immunology biosimilars as well as several other biosimilar assets currently under development. The terms see Biocon hand over $2bn in cash and $1bn . All our applications are subject to a robust regulatory review before a product can be brought to market. Semglee (insulin glargine) will be the first test of the FDA's interchangeability concept for biosimilars, but Viatris aims to grow its biosimilar revenues with multiple products. VIATRIS and the Viatris Logo are trademarks and GLOBAL HEALTHCARE GATEWAY, PARTNER OF CHOICE and the Global Healthcare Gateway logo are registered trademarks of Mylan Inc., a Viatris company. Viatris is a unique global healthcare company focused on a wide variety of therapeutic areas, empowering people worldwide by expanding their access to a broad range of trusted, quality medications, regardless of geography or circumstance. We produce medicines for patients across a broad range of major therapeutic areas, spanning both noncommunicable and infectious diseases. Leveraging our collective expertise to connect people to products and services. Our diverse and differentiated portfolio Brands Viatris estimated global revenues from the biosimilar business being transferred to Biocon is approximately $875 million, split among 5 biosimilars being actively marketed. Viatris is committed to improving the health and well-being of communities just like yours through strong partnerships dedicated to providing education, outreach, and better access to treatment. In the second quarter 2021 earnings conference, Viatris officials said they also have confidence in their aflibercept product candidate, which they hope to get through the FDA review process ahead of rival companies. Viatris is committed to increasing patient R&D: 1st Interchangeable biosimilar approved by FDA in U.S., Semglee (insulin glargine-yfgn)* 1st Adalimumab biosimilar approved Were the first ones to finish a [phase 3] clinical trial, Goettler said. Were leading right now. Biosimilar medicines are approved by regulatory authorities as highly similar to the originally approved brand version with no clinically meaningful differences in safety or efficacy. Significant changes also are subject to review by regulatory agencies. New Drug Information Fylnetra (pegfilgrastim-pbbk): The FDA approved Amneal's Fylnetra (pegfilgrastim-pbbk) a leukocyte . Links to Viatris affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Insulin aspart Novolog (Novo Nordisk) MYL-1601D Viatris/Biocon 2022; pending FDA approval SAR341402 Sanofi Phase III trials Insulin glargine Lantus (Sanofi) Semglee Viatris/Biocon November 2021 . To learn which products have been approved for use in a particular country, please visit that countrys page for a full listing of available drug products. In February 2021, Viatris launched Hulio in Canada and Japan. The page you are about to visit contains information about Viatris that is specific to. . You may also be interested in. Biosimilar versions are increasingly available as therapeutic alternatives for patients facing many serious diseases, including diabetes, autoimmune disorders and multiple cancers. Brands accounted for $2.48bn, or ~60% of revenues, Complex Gx and Biosimilars $355m, or ~9%, and generics accounted for. EPIPEN* (epinephrine injection, USP) Auto-Injector 0.3 mg. EPIPEN Jr* (epinephrine injection, USP) Auto-Injector 0.15 mg. EPTIFIBATIDE Injection. There are a number of competitors going through this. We are committed to improving access to high-quality medicines while working to ensure a reliable supply so patients can get the treatments they need, when and where they need them. That's in addition to the $3.335 billion Viatris (Nasdaq: VTRS) expects to receive in cash from the divesture of another formerly key piece of its business, biosimilars, in a deal with Biocon that . Manufacturing Expertise Contact Us Biologic medicines have become the standard of care for many serious diseases. We do this through a first-to-market emphasis and serving a key-pillar in our mission of expanding patient access. GLOBAL HEALTHCARE GATEWAY is a registered trademark of Mylan Inc., a Viatris Company. Our global portfolio, supported by our science, medical and manufacturing expertise, delivers global brands, biosimilars and generics - including complex and branded generics. Learn about our story, explore our products and browse career opportunities. marketing authorization approvals globally. Biologic medicines are used to treat many types of health conditions, such as cancer and rheumatoid arthritis. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and proven commercial capabilities to bring trusted, quality medicines to patients worldwide. We offer one of the industry's largest and most diverse global biosimilars franchises focused on the areas of oncology, immunology, endocrinology, ophthalmology and dermatology. Teva's Global R&D organization helps propel the company's mission to be a global leader in generics and biopharmaceuticals. Although the companies are not yet profitable; Viatris has the expertise, infrastructure and marketing to make these businesses EBITDA positive. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country. We also offer beyond the medicine solutions and services such as diagnostics, health literacy support and digital tools to help patients better manage their health. Viatris earned $17.8bn revenues in 2021, with EBITDA of $6bn. Our diverse and differentiated portfolio, supported by world-class commercial and regulatory expertise, delivers trusted, quality medicines that treat nine out of 10 of the World Health Organizations (WHO) leading causes of death and more than 200 of our medicines are on the WHO Essential Medicines List. PITTSBURGH and BENGALURU, India, Nov. 16, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. today announced the U.S. launch of interchangeable biosimilars SEMGLEE (insulin glargine-yfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with . This quarterly pipeline wrap-up provides a review of newly approved biosimilars, an update on the biosimilar pipeline and news of note on biosimilars in the approval process. The company is far less active in terms of biosimilar and complex generic sales in South and Central America, Africa, the Middle East, and Russia. Advancing sustainable operations and innovative solutions to improve patient health. *Not all of the products listed have been approved for use in all countries. One of the ways we're working to achieve this goal is our focus on biosimilar medicines. All rights reserved. Some examples of our capabilities include: Protecting patients and consumer health by ensuring the quality and safety of our products is at the heart of how we operate across our network. Our pipeline and research and development capabilities, which are focused on investments to continue moving the company up the value chain, include expertise in formulation, device development, toxicology, analytical, clinical, bioanalytical, medical affairs, product safety and risk management across a wide range of product types. We know that what we do directly impacts the health and well-being of patients. The Indian group is paying $3.3bn to take control of the partnership, allowing Viatris to pay down debt and focus on fewer, higher-margin areas. The biosimilars businesses owned by Viatris and Biocon have been intertwined for many years, and the partnership is heading for fuller consummation. become the standard of care About Viatris Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of . Collaborations. Viatris is a well-positioned manufacturer of legacy brand products, generics and biosimilars with a promising pipeline. of the ways were working to achieve this From product development to making or sourcing raw materials to producing finished dosage forms, every step of our development, manufacturing and monitoring processes is grounded in this commitment. Links to Viatris affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country. PITTSBURGH and BENGALURU, India, July 28, 2021 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS) and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn) injection as the first interchangeable biosimilar product under the 351(k) regulatory pathway. While its debt load appears frightening at first sight, the company is. We aim to develop more complex and novel products, providing greater opportunities to target gaps in patient care where others may not focus. We deliver a variety of over-the-counter products, including dietary supplements, homeopathics and cosmetics that help to empower people across the globe to live healthier lives. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country. From trusted prescription brands to quality, affordable generics, were dedicated to delivering increased access to the medicines you need, regardless of geography or circumstance. The overall sales decline in this combined category was attributed to generic drug competition. Viatris reported $333 million in combined biosimilar and complex generics sales for the quarter just ended, down 5% from $351 in the comparable 2020 quarter; however, biosimilar sales were up 40%. 2022 Viatris Inc. All Rights Reserved. 11 Aug 2021; In North America and the European Union, biosimilar sales for the quarter just ended were $309 million. Viatris global portfolio comprises more than 1,400 molecules across a broad range of major therapeutic areas, including best-in-class, iconic brand-name products, as well as global key brands, generics, including branded and complex generics, biosimilars and over-the-counter offerings. Our Pipeline Our pipeline and research and development capabilities, which are focused on investments to continue moving the company up the value chain, include expertise in formulation, device development, toxicology, analytical, clinical, bioanalytical, medical affairs, product safety and risk management across a wide range of product types. We offer one of the world's broadest portfolios of active pharmaceutical ingredients (API), which we provide to customers in more than 100 countries. 400+ Biosimilars can offer important, and often more affordable, treatment alternatives for patients and their physicians to tackle serious health issues, such as cancer, diabetes and autoimmune diseases. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country. By clicking continue below, you are leaving this site to arrive on a third-party site that is solely responsible for its content. Viatris empowers people worldwide to live healthier at every stage of life. EPINEPHRINE Injection, USP Auto-Injectors. Viatris has provided an update on its biosimilar pipeline, covering assets including insulin glargine, insulin aspart, aflibercept and bevacizumab, as part of its second quarter strategic update. Our high quality global manufacturing and supply chain excellence means we are uniquely positioned to improve access to medicine for your patients. Our biosimilars team is an integral member of our GLOBAL HEALTHCARE GATEWAY partnerships and helps make Viatris a true PARTNER OF CHOICE by extending our best-in-class in-house biosimilar expertise to your teams. This means actively looking into opportunities to build a critical mass of new drugs submitted through the 505(b)(2) regulatory pathway and New Chemical Entities (NCEs). ET, to review the Company's financial results for the third quarter ended September 30, 2022, and provide an update on . Viatris also reported complex generic and biosimilar sales by global region. In 2022, Viatris' biosimilars portfolio is anticipated to generate $875 million . Problems For Partner Revance's Lead Pipeline Candidate Has 'Direct Impact' . From product development to making or sourcing raw materials to producing finished dosage forms, every step of our development, manufacturing and monitoring processes is grounded in this commitment. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. We also invest in life-cycle management of certain key products in our current portfolio, with a focus on making improvements to existing products and expanding formulations to make them more widely available to those who may not have previously had access. biosimilars without borders Viatris is committed to increasing patient access to quality, affordable medicines. These vital products can help increase access for current and future patients while supporting the sustainability of healthcare systems. From early development to commercial launch of Active Pharmaceutical Ingredients (API), small molecules, novel biologics and biosimilars, our uniquely integrated "One . access to quality, affordable medicines. See separate articles for updates on traditional drugs, specialty drugs and cell/gene therapy. A generic version of Novo Nordisk's GLP-1 receptor agonist Wegovy (semaglutide) treatment for obesity is among seven complex generic injectables for which Viatris is claiming first-to-file status, as it looks to return to growth in 2024 and beyond. ERYGEL (Erythromycin) Topical Gel, USP. You are now leaving the Viatris page for a Viatris affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Our portfolio of numerous branded drugs, including iconic brands, helps patients to manage their health. California Supply Chain Transparency, UK and Australia Modern Slavery Statement. We monitor the performance of our products after approval and identify and implement any changes necessary to ensure quality. In Australia, Japan, and New Zealand, biosimilar and complex generic sales were $10 million, up 16%; and, so far, Viatris sales of biosimilars have not penetrated China. Links to Viatris affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. The approval of Viatris' generic Restasis will only provide a minor increase in sales. One Viatris has regulatory approvals for etanercept (Nepexto) and adalimumab (Hulio) biosimilars. Viatris' global biosimilars business with an estimated revenue of USD 875 million and EBITDA of USD 200 million for CY 2022 and estimated to exceed USD 1 billion in revenue next year Viatris' rights in all biosimilars assets including its in-licensed portfolio and an option to acquire Viatris' rights in bAflibercept Viatris' biosimilar portfolio and pipeline includes several products across multiple therapeutic areas, including oncology, immunology, diabetes and ophthalmology. But the company has several biosimilar drug candidates for . VIATRIS and the Viatris Logo are trademarks of Mylan Inc., a Viatris Company. The overall sales decline in this combined category was attributed to generic drug competition. 2022 Viatris Inc. All Rights Reserved. In 2020, Mylan and Pfizer's Upjohn combined to form VIATRIS. We're committed to increasing patient access to quality, affordable medicines. Viatris is currently seeking regulatory approval for bevacizumab and insulin aspart biosimilar candidates. We are committed to providing the tools, guidance, healthcare education and outreach necessary to connect your patients to trusted, quality medications. DOCTORS WITHOUT BORDERS AND MDECINS SANS FRONTIRES ARE REGISTERED TRADEMARKS OF MDECINS SANS FRONTIRES INTERNATIONAL. These vital products can help increase access for current and future patients while supporting the sustainability of healthcare systems. Viatris reported $333 million in combined biosimilar and complex generics sales for the quarter just ended, down 5% from $351 in the comparable 2020 quarter; however, biosimilar sales were up 40%. About Interchangeability An interchangeable biosimilar may be substituted for a reference product and may provide patients with greater access and drive conversion to biosimilars at the pharmacy counter. Lead Product (s): Glargine The Company also. Viatris is a global pharmaceutical company that believes in healthcare not as it is, but as it should be. Our pipeline and research and development capabilities, include expertise in formulation, device development, toxicology, analytical, clinical, bioanalytical, medical affairs, product safety and risk management across a wide range of therapeutic areas and product types. Impressive, but there is ~$22bn debt to pay off. Our pipeline Our pipeline and research and development capabilities, which are focused on investments to continue moving the company up the value chain, include expertise in formulation, device development, toxicology, analytical, clinical, bioanalytical, medical affairs, product safety and risk management across a wide range of product types. 2022 MJH Life Sciences and Center for Biosimilars.
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