Alvotech Announces Australian Marketing Authorization for


  • Will increase availability of cost-effective high-concentration low-volume adalimumab in Australia
  • First accredited biosimilar from the partnership with Cipla, which additionally consists of 4 different biosimilar candidates

REYKJAVIK, Iceland and MUMBAI, India, Nov. 14, 2022 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO), a worldwide biotech firm specializing within the improvement and manufacture of biosimilar medicines for sufferers worldwide introduced in the present day that the Therapeutic Items Administration of Australia has granted advertising and marketing authorization to Cipla Australia Pty Ltd (“Cipla”) for Alvotech’s AVT02, a high-concentration low-volume biosimilar to Humira® (adalimumab).

Alvotech’s biosimilar to Humira® (adalimumab) is accredited in Australia for advertising and marketing as a 40 mg/0.4 mL and 80 mg/0.8 mL resolution in a pre-filled syringe and 40 mg/0.4 mL resolution in a pre-filled pen, designed with the convenience of sufferers in thoughts. In Australia, the biosimilar can be marketed as Ciptunec™ and Ardalicip™.

“We’re more than happy in regards to the advertising and marketing authorization in Australia, following approval and profitable launches of Alvotech’s excessive focus biosimilar to Humira® in a number of markets in Europe and Canada. As we’re devoted to bettering world entry to inexpensive biologics, we welcome this step in our journey,” mentioned Mark Levick, CEO of Alvotech.

“The primary accredited biosimilar in Cipla’s partnership with Alvotech marks an necessary milestone. We look ahead to extending our footprint within the biosimilars market by growing the provision of cost-effective high-concentration low-volume adalimumab for Australian sufferers,” mentioned Nishant Saxena, CEO, Worldwide Enterprise (Europe & Rising Markets), of Cipla.

That is the primary accredited biosimilar from an unique commercialization partnership between Alvotech and Cipla, announced in July 2019. In November 2020, the companions prolonged their partnership to South Africa and in January 2021, the companions entered into an extra license and provide settlement for Australia and New Zealand for 4 biosimilar different candidates beneath improvement by Alvotech concentrating on immunology, ophthalmology, oncology, and bone illness.

About AVT02 / Ciptunec™ / Ardalicip™ (adalimumab)

AVT02, marketed as Ciptunec / Ardalicip in Australia, is a monoclonal antibody and accredited biosimilar to Humira® (adalimumab), which inhibits tumor necrosis issue. Permitted indications for Ciptunec / Ardalicip in Australia embrace rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s illness in adults and youngsters (≥ 6 years; weighing ≥ 40 kg), ulcerative colitis, psoriasis in adults and youngsters, hidradenitis suppurativa in adults and adolescents (from 12 years of age) and uveitis. The identical biosimilar has been accredited within the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland as Hukyndra®; and in Canada and Saudi Arabia as Simlandi™. Dossiers are beneath overview in a number of international locations, together with in america.

About Alvotech

Alvotech 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 worldwide chief within the biosimilar house by delivering high-quality, cost-effective merchandise, and companies, enabled by a completely built-in strategy and broad in-house capabilities. Alvotech’s present pipeline accommodates eight biosimilar candidates aimed toward treating autoimmune problems, eye problems, osteoporosis, respiratory illness, and most cancers. Alvotech has shaped a community of strategic industrial partnerships to offer world attain and leverage native experience in markets that embrace america, Europe, Japan, China, and different Asian international locations and enormous components 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), Cipla/Cipla Gulf/Cipla Med Professional (Australia, New Zealand, South Africa/Africa), JAMP Pharma Company (Canada), Yangtze River Pharmaceutical (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. (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 novel 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 experiences made obtainable by its companions. For extra info, please go to www.alvotech.com. Not one of the info on the Alvotech web site shall be deemed a part of this press launch.

Alvotech Ahead-Wanting Statements

Sure statements on this communication could also be thought of “forward-looking statements” throughout the which means of the Personal Securities Litigation Reform Act of 1955, as amended. Ahead-looking statements typically relate to future occasions or the long run monetary working efficiency of Alvotech and should embrace, for instance, Alvotech’s expectations relating to aggressive benefits, enterprise prospects and alternatives together with pipeline product improvement, future plans and intentions, outcomes, degree of actions, efficiency, objectives or achievements or different future occasions, regulatory overview and interactions, the success of its industrial partnerships, together with its partnership with Cipla, potential milestone and royalty funds, the passable responses to the FDA’s inspection findings and backbone of different deficiencies conveyed following the inspection of Alvotech’s manufacturing web site, the potential approval and industrial launch of its product candidates, the timing of the announcement of medical examine outcomes, regulatory approvals and market launches, together with in Australia, and the estimated measurement of the whole addressable market of Alvotech’s pipeline merchandise, and the industrial success of Ciptunec/Ardalicip, in Australia and different international locations, and Alvotech’s skill to enhance world entry to inexpensive biologics. In some instances, you’ll be able to establish forward-looking statements by terminology similar to “could”, “ought to”, “count on”, “intend”, “will”, “estimate”, “anticipate”, “imagine”, “predict”, “potential”, “purpose” 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 components which might trigger precise outcomes to vary materially from these expressed or implied by such forward-looking statements. These forward-looking statements are primarily based upon estimates and assumptions that, whereas thought of cheap 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 that will trigger precise outcomes to vary materially from present expectations embrace, however usually are not restricted to: (1) the result of any authorized proceedings which may be instituted towards Alvotech or others following the enterprise mixture between Alvotech Holdings S.A., Oaktree Acquisition Corp. II and Alvotech; (2) the power to keep up inventory trade itemizing requirements; (3) adjustments in relevant legal guidelines or laws; (4) the chance that Alvotech could also be adversely affected by different financial, enterprise, and/or aggressive components; (5) Alvotech’s estimates of bills and profitability; (6) Alvotech’s skill to develop, manufacture and commercialize the merchandise and product candidates in its pipeline together with Ciptunec/Ardalicip; (7) actions of regulatory authorities, which can have an effect on the initiation, timing and progress of medical research or future regulatory approvals or advertising and marketing authorizations; (8) the power of Alvotech or its companions to reply to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the power of Alvotech or its companions to enroll and retain sufferers in medical research; (10) the power of Alvotech or its companions to achieve approval from regulators for deliberate medical research, examine plans or websites; (11) the power of Alvotech’s companions to conduct, supervise and monitor current and potential future medical research, which can impression improvement timelines and plans; (12) Alvotech’s skill to acquire and keep regulatory approval or authorizations of its merchandise, together with Ciptunec/Ardalicip, together with the timing or probability of enlargement into extra markets or geographies; (13) the success of Alvotech’s present and future collaborations, joint ventures, partnerships or licensing preparations, together with the partnership with Cipla; (14) Alvotech’s skill, and that of its industrial companions, to execute their commercialization technique for accredited merchandise, together with Ciptunec/Ardalicip; (15) Alvotech’s skill to fabricate adequate industrial provide of its accredited merchandise, together with Ciptunec/Ardalicip; (16) the result of ongoing and future litigation relating to Alvotech’s merchandise and product candidates; (17) the potential impression of the continued COVID-19 pandemic on the FDA’s overview timelines, together with its skill to finish well timed inspection of producing websites; and (18) different dangers and uncertainties set forth within the sections entitled “Danger Elements” and “Cautionary Word Relating to Ahead-Wanting Statements” in paperwork that Alvotech could every so often file or furnish with the SEC. There could also be extra dangers that Alvotech doesn’t presently know or that Alvotech at the moment believes are immaterial that might additionally trigger precise outcomes to vary from these contained within the forward-looking statements. Nothing on this communication must be thought to be a illustration by any individual that the forward-looking statements set forth herein can be achieved or that any of the contemplated outcomes of such forward-looking statements can be achieved. You shouldn’t place undue reliance on forward-looking statements, which communicate 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, staff, associates, brokers, advisors, or representatives liable the least bit for the availability of this communication, the data contained on this communication, or the omission of any info from this communication.

CONTACTS

Alvotech Investor Relations and International Communication
Benedikt Stefansson
alvotech.ir[at]alvotech.com



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