“We thank Sandra for her valuable contribution to Alvotech as she effectively led our quality team through the recent FDA facility inspection, which has now led to the approval of our high-strength interchangeable biosimilar to Humira in the US. “said Robert Wessman, president and CEO of Alvotech. “Christina will be able to hit the ground running, thanks to her extensive experience in GMP and regulatory compliance at our sister company, Alvogen. We are delighted to have her on board as we work hard to expand our manufacturing operations in preparation for several near-term product launches in global markets. “Continuous improvement, quality and compliance are at the heart of everything we do.
Christina Siniscalchi has 25 years of experience in the U. S. pharmaceutical industry. U. S. Prior to joining Norwich Pharmaceuticals, now Alvogen, he worked at Mallinckrodt Pharmaceuticals. He holds a Master of Science in Regulatory Affairs and Quality Assurance from Temple University and a Bachelor of Science in Applied Biology from the Georgia Institute of Technology.
About AlvotechAlvotech is a biotechnology company founded by Robert Wessman and focused solely on the development and production of biosimilar medicines for patients around the world. Alvotech seeks to become a global leader in biosimilars by offering high-quality, cost-effective products and services, made possible through fully incorporated technology and extensive in-house capabilities. Alvotech’s existing portfolio includes eight disclosed biosimilar applicants intended for the treatment of autoimmune diseases, eye disorders, osteoporosis, respiratory diseases and cancer. Alvotech has formed a network of strategic business partnerships to deliver global success and leverage local expertise in markets such as the United States, Europe, Japan, China and other Asian countries and major parts of South America, Africa and the Middle East. Alvotech’s commercial components are Teva Pharmaceuticals, a US subsidiary of Teva Pharmaceutical Industries Ltd. (USA), STADA Arzneimittel AG (EU), Fuji Pharma Co. , Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia). and New Zealand), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co. , Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co. , Ltd. (Thailand, Vietnam, Philippines and South Korea). Each business component covers a unique set of products and territories. Unless otherwise indicated, Alvotech disclaims all responsibility for the content of periodic documents, disclosures and other reports made through its components. For more information, visit www. alvotech. com. None of the data on Alvotech’s online page will be considered part of this press release.
Certain statements contained in this release may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements sometimes relate to long-term events or Alvotech’s long-term operational monetary functionality and could include, for example, Alvotech’s expectations related to its expected long-term activities, monetary functionality, use of proceeds from the user’s position and long-term monetary functions. use of Yorkville facilities. In some cases, you can identify forward-looking statements by terms such as “possibly”, “would”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”. “forward-looking”, “target” or “continue”, or the negative terminology of those terms or their diversifications or similar terminology. These forward-looking statements are subject to risks, uncertainties and other matters that may also cause actual effects to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based on estimates and assumptions that, while considered conservative by Alvotech and its management, are inherently doubtful and are inherently subject to hazards, variations and unforeseen events, many of which are beyond the control of Alvotech. They may also cause actual effects to differ materially from existing expectations including, but not limited to: (1) the ultimate results of any legal proceedings that would possibly be brought against Alvotech or others as a result of the business combination . corporations between Alvotech Holdings S. A. and Oaktree Acquisition Corp. II and Alvotech; (2) adjustments in applicable legislation or regulations; (3) the possibility that Alvotech may be harmed by other economic, commercial and/or competitive issues; (4) Alvotech’s earnings and expense estimates; (5) Alvotech’s ability to develop, manufacture and advertise its product pipeline and product candidates; (6) moves by regulatory authorities, which would likely include the initiation, timing and progress of clinical studies or regulatory approvals or long-term market positioning authorizations; (7) the ability of Alvotech or its partners to obtain regulatory approval for planned clinical studies, designs or examination sites; (8) the ability of Alvotech’s partners to conduct, supervise and monitor existing and future long-term clinical studies, which would potentially have an effect on timelines and progression plans; (9) Alvotech’s ability to discharge and maintain regulatory approval or clearances for its products, including the timing or likelihood of expansion into other market positions or geographies; (10) the good fortune of Alvotech’s existing and long-term collaborations, joint ventures, partnerships or licensing agreements; (11) the ability of Alvotech and its business partners to execute its market positioning strategy for approved products; (12) Alvotech’s ability to manufacture a sufficient advertising source for its approved products; (13) the final results of pending and long-term litigation relating to Alvotech’s products and product candidates; (14) the potential impact of the ongoing COVID-19 pandemic on FDA review schedules, including its ability to conduct timely inspections of production sites; (15) the effect of deteriorating macroeconomic conditions, adding inflation and emerging interest rates and general market position conditions, the war in Ukraine and global geopolitical tensions, as well as the COVID -19 pandemic in ongoing and evolving, in Alvotech’s activities, monetary position, strategy and planned milestones. ; (16) long-term liquidity and financing needs, which would likely have an effect on the intended use of the Yorkville Fund or other financing resources; and (17) other dangers and concerns set forth in the sections titled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may file with or provide from time to time to the SEC. There may be other dangers of which Alvotech is not aware or which Alvotech considers insignificant that may also cause actual effects to differ from those contained in the forward-looking statements. Nothing in this communication should be construed as a representation by any user that the forward-looking statements set forth herein will be achieved or that any of the intended effects of such forward-looking statements will be achieved. You deserve not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech undertakes no legal responsibility to update such forward-looking statements or to inform the recipient of any matter of which any of them become aware, which may also be any matter discussed in this communication. Alvotech assumes no liability for any loss or damage (whether foreseeable or otherwise) suffered or incurred by any user or entity as a result of anything contained in or overlooked in this communication and such liability is expressly disclaimed. Recipient agrees not to sue or hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors or representatives liable in any respect for the provision of this communication, the data contained in this communication or the omission of any data in this communication.
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