REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 27, 2025 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a world biotech firm specializing within the improvement and manufacture of biosimilar medicines for sufferers worldwide, and Teva Prescription drugs, a U.S. affiliate of Teva Pharmaceutical Industries (NYSE:) Ltd. (NYSE and TASE: TEVA), at this time introduced that the U.S. Meals and Drug Administration (FDA) has accepted for evaluation Biologics License Functions (BLA) for AVT05, Alvotech’s proposed biosimilar to Simponi ® and Simponi Aria ® (golimumab), that are prescribed to deal with quite a lot of inflammatory situations. These are the primary U.S. BLA submitting acceptances introduced for a biosimilar candidate to golimumab. The FDA evaluation course of for these functions is anticipated to be accomplished within the fourth quarter of 2025.
“This is a significant step towards being able to offer U.S. patients access to biosimilar golimumab,” stated Joseph McClellan, Chief Scientific Officer of Alvotech. Our in-house functionality permitting us to match the cell line and course of used to fabricate the reference biologic, has given us an necessary head begin in growing a biosimilar candidate to Simponi ® and Simponi Aria ® for international markets.”
Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva, added, Biosimilars are ushering a brand new therapy paradigm and have turn into an integral staple within the healthcare ecosystem. Teva’s strategic partnership with Alvotech underscores our dedication to proceed to deliver cost-saving choices to extra sufferers and ship higher outcomes for these with inflammatory situations.
In April 2024, Alvotech introduced constructive top-line outcomes from a confirmatory medical examine evaluating efficacy, security, and immunogenicity between AVT05 and Simponi ® in sufferers with reasonable to extreme rheumatoid arthritis. Beforehand, in November 2023, Alvotech introduced constructive topline outcomes from a pharmacokinetic examine which assessed the pharmacokinetics, security, and tolerability of AVT05 in comparison with Simponi ® in wholesome grownup members.
In August 2020, Alvotech and Teva entered right into a strategic partnership for the unique commercialization of 5 of Alvotech’s biosimilar product candidates, together with AVT05. The partnership has since expanded and now features a whole of 9 merchandise. Alvotech handles improvement and manufacturing utilizing its purpose-built end-to-end platform, whereas Teva is answerable for commercialization within the U.S., which leverages Teva’s expertise and in depth gross sales and advertising infrastructure.
Since Alvotech and Teva entered into the strategic partnership, two biosimilars developed underneath the partnership have achieved FDA approval. In February 2024, the FDA permitted SIMLANDI ® (adalimumab-ryvk), the primary high-concentration, citrate-free interchangeable biosimilar to Humira ® (adalimumab). SIMLANDI was launched within the U.S. in Could 2024. In April 2024, the FDA permitted SELARSDI™ (ustekinumab-aekn) as a biosimilar to Stelara ® (ustekinumab). U.S. market entry date for SELARSDI™ is deliberate for February 2025.
About AVT05 AVT05 is a biosimilar candidate for Simponi ® and Simponi Aria ® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis issue alpha (TNF alpha). Elevated TNF alpha ranges have been implicated within the pathophysiology of a number of power inflammatory ailments comparable to rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.1 AVT05 is an investigational product and has not obtained regulatory approval in any nation. Biosimilarity has not been established by regulatory authorities and isn’t claimed.
About SIMLANDI ® (adalimumab-ryvk) SIMLANDI is a monoclonal antibody and has been permitted as a biosimilar to Humira ® (adalimumab) in over 50 international locations globally, together with the U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South Africa. The biosimilar is at present marketed within the U.S. as SIMLANDI and underneath personal label as adalimumab-ryvk, in Europe as HUKYNDRA ®, in Canada as SIMLANDI and in Australia as ADALACIP ®. Functions are additionally underneath evaluation in a number of international locations globally.
About SELARSDI™ (ustekinumab-aekn) SELARSDI is a monoclonal antibody and has been permitted as a biosimilar to Stelara ® (ustekinumab). Ustekinumab binds to 2 cytokines, IL-12 and IL-23, that are concerned in inflammatory and immune responses.2 This biosimilar was launched in Canada as JAMTEKI ®, in Europe as UZPRUVO ® and in Japan as USTEKINUMAB BS (F) ®. It has been permitted within the U.S. as SELARSDI. Functions are additionally underneath evaluation in a number of international locations globally.
Use of trademarksSimponi ®, Simponi Aria ® and Stelara ® are registered logos of Johnson & Johnson (NYSE:). Humira ® is a registered trademark of AbbVie Inc (NYSE:).
About AlvotechAlvotech is a biotech firm, based by Robert Wessman, targeted solely on the event and manufacture of biosimilar medicines for sufferers worldwide. Alvotech seeks to be a world chief within the biosimilar area by delivering prime quality, cost-effective merchandise, and providers, enabled by a totally built-in method and broad in-house capabilities. Two biosimilars to Humira ® (adalimumab) and Stelara ® (ustekinumab) are already permitted and marketed in a number of international markets. The present improvement pipeline consists of 9 disclosed biosimilar candidates geared toward treating autoimmune problems, eye problems, osteoporosis, respiratory illness, and most cancers. Alvotech has shaped a community of strategic industrial partnerships to offer international attain and leverage native experience in markets that embrace the USA, Europe, Japan, China, and different Asian international locations and enormous elements of South America, Africa and the Center East. Alvotech’s industrial companions embrace Teva Prescription drugs, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Professional (Australia, New Zealand, South Africa/Africa), JAMP Pharma Company (Canada), Yangtze River Pharmaceutical (TADAWUL:) (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Center East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd (NASDAQ:). (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Prescription drugs Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Every industrial partnership covers a singular set of product(s) and territories. Besides as particularly set forth therein, Alvotech disclaims accountability for the content material of periodic filings, disclosures and different studies made accessible by its companions. For extra info, please go to our investor portal or our web site. Not one of the info on the Alvotech web site shall be deemed a part of this press launch.
About TevaTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a world pharmaceutical chief, harnessing its generics experience and stepping up innovation to proceed the momentum behind the invention, supply, and expanded improvement of contemporary drugs. For over 120 years, Teva’s dedication to bettering well being has by no means wavered. At this time, the corporate’s international community of capabilities permits its ~37,000 workers throughout 57 markets to push the boundaries of scientific innovation and ship high quality medicines to assist enhance well being outcomes of tens of millions of sufferers day-after-day. To be taught extra about how Teva is all in for higher well being, go to www.tevapharm.com.
Alvotech Ahead Trying StatementsCertain statements on this communication could also be thought of forward-looking statements throughout the that means of the Non-public Securities Litigation Reform Act of 1995, as amended. Ahead-looking statements typically relate to future occasions or the longer term monetary working efficiency of Alvotech and will embrace, for instance, Alvotech’s expectations relating to its potential to finish the event and achieve advertising authorization for AVT05, Alvotech’s aggressive benefits, enterprise prospects and alternatives together with product launches, pipeline product improvement, income and diversification, future plans and intentions, outcomes, degree of actions, efficiency, objectives or achievements or different future occasions, regulatory submissions, evaluation and interactions, the potential approval and industrial launch of its product candidates, the timing of regulatory approval, and market launches. In some circumstances, you’ll be able to establish forward-looking statements by terminology comparable to could, ought to, anticipate, intend, will, estimate, anticipate, consider, predict, potential, intention or proceed, or the negatives of those phrases or variations of them or related terminology. Such forward-looking statements are topic to dangers, uncertainties, and different elements which may trigger precise outcomes to vary materially from these expressed or implied by such forward-looking statements. These forward-looking statements are based mostly upon estimates and assumptions that, whereas thought of affordable by Alvotech and its administration, are inherently unsure and are inherently topic to dangers, variability, and contingencies, a lot of that are past Alvotech’s management. Elements which will trigger precise outcomes to vary materially from present expectations embrace, however will not be restricted to: (1) the power to develop and manufacture biosimilar candidates in Alvotech’s present pipeline and manufacture permitted and marketed biosimilars; (2) the power to take care of inventory alternate itemizing requirements; (3) modifications in relevant legal guidelines or rules; (4) the chance that Alvotech could also be adversely affected by different financial, enterprise, and/or aggressive elements; (5) Alvotech’s estimates of income, bills and profitability; (6) Alvotech’s potential to develop, manufacture and commercialize the merchandise and product candidates in its pipeline; (7) the power of Alvotech or its companions to enroll and retain sufferers in medical research; (8) the power of Alvotech or its companions to achieve approval from regulators for deliberate medical research, examine plans or websites; (9) the power of Alvotech’s companions to conduct, supervise and monitor present and potential future medical research, which can impression improvement timelines and plans; (10) Alvotech’s potential to acquire and keep regulatory approval or authorizations of its merchandise, together with the timing or probability of growth into extra markets or geographies; (11) the success of Alvotech’s present and future collaborations, joint ventures, partnerships or licensing preparations; (12) Alvotech’s potential, and that of its industrial companions, to execute their commercialization technique for permitted merchandise; (13) Alvotech’s potential to fabricate adequate industrial provide of its permitted merchandise; (14) the end result of ongoing and future litigation relating to Alvotech’s merchandise and product candidates; (15) the impression of worsening macroeconomic situations, together with rising inflation and rates of interest and basic market situations, conflicts in Ukraine, the Center East and different international geopolitical pressure, on the Firm’s enterprise, monetary place, technique and anticipated milestones and (16) different dangers and uncertainties set forth within the sections entitled Danger Elements and Cautionary Be aware Relating to Ahead-Trying Statements in paperwork that Alvotech could infrequently file or furnish with the SEC. There could also be extra dangers that Alvotech doesn’t presently know or that Alvotech at present believes are immaterial that might additionally trigger precise outcomes to vary from these contained within the forward-looking statements. Nothing on this communication ought to be considered a illustration by any individual that the forward-looking statements set forth herein shall be achieved or that any of the contemplated outcomes of such forward-looking statements shall be achieved. You shouldn’t place undue reliance on forward-looking statements, which converse solely as of the date they’re made. Alvotech doesn’t undertake any responsibility to replace these forward-looking statements or to tell the recipient of any issues of which any of them turns into conscious of which can have an effect on any matter referred to on this communication. Alvotech disclaims any and all legal responsibility for any loss or harm (whether or not foreseeable or not) suffered or incurred by any individual or entity on account of something contained or omitted from this communication and such legal responsibility is expressly disclaimed. The recipient agrees that it shall not search to sue or in any other case maintain Alvotech or any of its administrators, officers, workers, associates, brokers, advisors, or representatives liable the least bit for the supply of this communication, the knowledge contained on this communication, or the omission of any info from this communication.
Teva Cautionary Be aware Relating to Ahead Trying StatementsThis press launch comprises forward-looking statements throughout the that means of the Non-public Securities Litigation Reform Act of 1995, that are based mostly on administration’s present beliefs and expectations and are topic to substantial dangers and uncertainties, each recognized and unknown, that might trigger our future outcomes, efficiency or achievements to vary considerably from that expressed or implied by such forward-looking statements. You’ll be able to establish these forward-looking statements by way of phrases comparable to ought to, anticipate, anticipate, estimate, goal, could, mission, steering, intend, plan, consider and different phrases and phrases of comparable that means and expression in reference to any dialogue of future working or monetary efficiency. Necessary elements that might trigger or contribute to such variations embrace dangers referring to: our potential to commercialize Alvotech’s biosimilar product candidate to Simponi ® and Simponi Aria ® (golimumab) underneath the strategic partnership with Alvotech, as soon as regulatory approval is obtained; our potential to efficiently compete within the market, together with our potential to develop and commercialize extra pharmaceutical merchandise; our potential to efficiently execute our Pivot to Development technique, together with to develop our progressive and biosimilar medicines pipeline and profitably commercialize the progressive medicines and biosimilar portfolio, whether or not organically or by means of enterprise improvement, and to maintain and focus our portfolio of generic medicines; and different elements mentioned in our Quarterly Report on Type 10-Q for the third quarter of 2024, and in our Annual Report on Type 10-Okay for the yr ended December 31, 2023, together with within the part captioned Danger Elements. Ahead-looking statements converse solely as of the date on which they’re made, and we assume no obligation to replace or revise any forward-looking statements or different info contained herein, whether or not on account of new info, future occasions or in any other case. You might be cautioned to not put undue reliance on these forward-looking statements.
Sources
Simponi ® (golimumab) FDA product label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125289s150lbl.pdf. Accessed on January 14, 2025.Selarsdi™ (ustekinumab-aekn) FDA product label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761343s000lbl.pdf. Accessed on January 14, 2025.
CONTACTS FOR THE MEDIA AND INVESTOR RELATIONS
Teva
Teva Media [email protected] Teva Investor Relations Inquires [email protected]
Enterprise
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