Accord BioPharma Receives FDA Approval for New Denosumab Biosimilars

Accord BioPharma Announces FDA Approval of Denosumab Biosimilars

Accord BioPharma, Inc., a specialty unit of Intas Pharmaceuticals, has revealed that the U.S. Food and Drug Administration (FDA) has approved two significant biosimilars: OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu). These biosimilars are designed to offer more accessible treatment options for patients dealing with osteoporosis and skeletal-related complications due to specific types of cancers, thereby enhancing Accord's portfolio in a competitive market.

Overview of OSVYRTI and JUBEREQ

The approval marks the introduction of Accord BioPharma's fourth and fifth biosimilars into the U.S. market. OSVYRTI is established as a biosimilar to Prolia® (denosumab), targeting a range of patients including postmenopausal women with osteoporosis at heightened risk of fractures. The treatment is also indicated for men experiencing the same condition, as well as individuals undergoing treatments for prostate cancer and breast cancer. A highlighted aspect of this biosimilar is its Boxed Warning, which cautions against the risk of severe hypocalcemia, particularly in patients with advanced kidney disease.

Similarly, JUBEREQ has been approved as a biosimilar to Xgeva® (denosumab). This medication is crucial for patients with multiple myeloma and those suffering from bone metastases, addressing various needs such as preventing skeletal-related events and treating conditions like giant cell tumor of bone and hypercalcemia of malignancy.

Rationale Behind the Approvals

Chrys Kokino, President of Accord North America, noted that both OSVYRTI and JUBEREQ cater to diverse medical needs, facilitating alternatives for patients and reducing financial barriers to essential therapies. The increasing injection of biosimilars like these into the market aligns with Accord's mission to improve access to quality treatment options while maintaining costs manageable for patients.

Clinical Trials and Development

The FDA's decision was substantiated by two pivotal clinical trials: a Phase I study focusing on pharmacokinetics and a Phase III trial analyzing efficacy and safety. The results demonstrated that both OSVYRTI and JUBEREQ exhibited comparable characteristics to their reference products, showing no clinically meaningful gaps in the safety and efficacy profiles between the biosimilars and their branded counterparts.

In particular, the Phase I trial compared JUBEREQ to Xgeva in healthy adults, and established that the pharmacokinetic parameters were aligned with expectations between the two products. The Phase III trial brought forward similar conclusions regarding OSVYRTI and Prolia, establishing that they are highly similar.

Future Growth and Market Plans

Accord aims to launch OSVYRTI and JUBEREQ into the market in 2026. Notably, these biosimilars are the first that Accord has fully developed in-house, distancing from prior partnerships for manufacturing. Accord's commitment towards the biosimilar sector shines through their investments aimed at supporting lower costs in the healthcare system while also improving patient options.

Conclusion

Accord BioPharma's recent FDA approval achievements highlight a promising future in their biosimilar endeavors. As they prepare for the launch of OSVYRTI and JUBEREQ, their emphasis on making effective treatments more accessible could play a vital role in addressing the growing demand for affordable healthcare solutions in the U.S.

For Additional Information

For comprehensive safety information regarding OSVYRTI and JUBEREQ, patients and healthcare providers are encouraged to review the prescribing information accessible from Accord BioPharma's official site.