Celltrion wins 3 biosimilar approvals in Australia, eyes Oceania growth
South Korea's pharmaceutical giant Celltrion said Thursday it has received regulatory approvals for three biosimilars in Australia over the past two weeks, a move expected to amplify its presence in the Oceania market.
According to the biosimilar maker, the approvals from Australia's Therapeutic Goods Administration cover eye treatment Eydenzelt, its version of Regeneron Pharmaceuticals' Eylea, as well as two bone-related therapies Stoboclo and Osenvelt, referencing Amgen's Prolia and Xgeva, respectively.
With the newest additions, Celltrion now has 11 products either approved or marketed in Australia.
'Australia's biosimilar-friendly environment continues to spur our growth momentum,' a company official said. 'We aim to complete the remaining commercialization steps swiftly to ensure stable supply in the market.'
Eydenzelt, available in both vial and prefilled syringe forms, has been approved for the treatment of myopic choroidal neovascularization, or CNV, making it the first biosimilar in its category to gain approval in Australia.
Its reference product, Eylea, generated $9.52 billion in global sales last year, underlining strong market potential, the company noted.
Stoboclo and Osenvelt were approved for all indications held by their reference biologics in Australia.
Stoboclo is indicated for postmenopausal osteoporosis, while Osenvelt is approved for preventing skeletal-related events in cancer patients with bone metastases and for treating giant cell tumors of bone. Their originator drugs Prolia and Xgeva recorded a combined $6.59 billion in global sales last year.
The company said the approvals mark a key milestone in expanding its global reach, including in the Oceania region, with additional plans to broaden its pipeline in ophthalmology and bone-related therapies.
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Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. HEPATITIS B VIRUS REACTIVATION NEUROLOGIC REACTIONS HEMATOLOGIC REACTIONS HEART FAILURE AUTOIMMUNITY IMMUNIZATIONS ADVERSE REACTIONS INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), AVTOZMA ® (tocilizumab-anho), STEQEYMA ® (ustekinumab-stba), STOBOCLO ® (denosumab-bmwo), OSENVELT ® (denosumab-bmwo) and OMLYCLO ® (omalizumab-igec), as well as the novel biologic ZYMFENTRA ® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Humira is a registered trademark of AbbVie. YUFLYMA ® is a registered trademark of Celltrion, Inc., used under license.
