US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab)

Rhea-AI Summary

Shanghai Henlius Biotech and Organon (NYSE: OGN) announced the US FDA's acceptance of their Biologics License Application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab). The application is supported by comprehensive head-to-head studies, including analytical comparisons and two clinical trials. Under a 2022 license agreement, Organon holds exclusive commercialization rights for HLX14 in the US, EU, and Canada, excluding China. The clinical program included a phase 1 study in healthy males and a phase 3 trial in postmenopausal women with high-risk osteoporosis.

Positive

• FDA acceptance of BLA for HLX14 biosimilar marks significant regulatory progress
• Exclusive commercialization rights secured for major markets (US, EU, Canada)
• Comprehensive clinical data package supports application

Negative

• None.

Insights

Biotech Research Analyst

The FDA's acceptance of the BLA for HLX14 marks a significant milestone in Organon's biosimilar strategy. This denosumab biosimilar candidate targets a substantial market, as PROLIA/XGEVA generated $3.4 billion in global sales for Amgen in 2022. The robust clinical development program, including comprehensive PK studies and a Phase 3 trial, strengthens the likelihood of approval.

The partnership with Henlius provides Organon exclusive commercialization rights in major markets, positioning them to capture market share once PROLIA loses exclusivity in 2025. Biosimilars typically launch at 15-30% below reference product prices, offering significant revenue potential while expanding patient access. The successful development and commercialization could materially impact Organon's future revenue stream.

SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)-- Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab).

Denosumab has been approved in various countries and regions under different trade names for a range of different indications, such as for the treatment of osteoporosis in postmenopausal women at high risk for fracture, among others.

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX14. The agreement covers markets such as the United States, the European Union, and Canada. An exception to the agreement is China.

The filing is based on data from a series of head-to-head studies for HLX14, including comparative quality analytical studies and two clinical studies. The first was a two-part phase 1 clinical study in Chinese healthy adult male subjects. Part 1 was an open-label, randomized, parallel-controlled, single-dose, two-arm pilot study with the primary objective to compare the PK parameters of HLX14 and EU-sourced PROLIA after subcutaneous injection to provide further basis for the study design of part 2. Part 2 was a double-blind, randomized, parallel-controlled, single-dose, four-arm study with the primary objective to compare the pharmacokinetic similarity of HLX14 with US-, EU-, and China-sourced PROLIA after subcutaneous injection. The second was a randomized, double-blind, international multicenter, parallel-controlled phase 3 clinical study comparing the efficacy, safety, tolerability, and immunogenicity of HLX14 with EU-sourced reference PROLIA in postmenopausal women with osteoporosis at high risk for fracture.

About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 4 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. Henlius has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP.

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. Henlius has launched HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANNAIJIA (neratinib), and HANSIZHUANG (serplulimab), an innovative product that has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.

To learn more about Henlius, visit https://www.henlius.com/en/index.html and connect with us on LinkedIn at https://www.linkedin.com/company/henlius/.

About Organon
Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon’s diverse portfolio offers more than 60 medicines and products in women’s health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon’s current products, the company invests in innovative solutions and research to drive future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical partners and innovators looking to commercialize their products by leveraging its scale and agile presence in fast growing international markets.

Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

For more information, visit http://www.organon.com and connect with us on LinkedIn, Instagram, X (formerly known as Twitter) and Facebook.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s license and supply agreement with Henlius and the respective business goals and objectives of each company. Forward-looking statements may be identified by words such as “vision,” “pursuing,” “future,” “expects,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission (“SEC”), including Organon’s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC’s Internet site www.sec.gov. References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.

XGEVA and PROLIA are trademarks registered in the United States in the name of Amgen Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241029648679/en/

Organon Media:

Karissa Peer

(614) 314-8094

Hannah Silver

(917) 509-8864

Organon Investors:

Jennifer Halchak

(201) 275-2711

Henlius Media:

Bella Zhou

wenting_zhou@henlius.com

Janice Han

jiayi_han@henlius.com

Source: Organon & Co.

FAQ

What is the status of Organon's (OGN) HLX14 biosimilar FDA application?

The FDA has accepted the Biologics License Application (BLA) for HLX14, a biosimilar candidate of PROLIA/XGEVA (denosumab).

Which markets are covered in Organon's (OGN) 2022 license agreement for HLX14?

The license agreement covers the United States, European Union, and Canada, with China being excluded from the agreement.

What clinical studies support Organon's (OGN) HLX14 biosimilar application?

The application is supported by comparative quality analytical studies, a two-part phase 1 study in healthy male subjects, and a phase 3 trial in postmenopausal women with osteoporosis.