Aurobindo Pharma has announced a significant milestone in its biosimilar development program. The company's subsidiary, Curateq Biologics, has successfully completed a Phase 1 pharmacokinetics study for BP16, a proposed biosimilar to the widely used osteoporosis and bone loss treatments, Prolia® and Xgeva® (denosumab).

Phase 1 Study Completion

The completion of this Phase 1 study marks a crucial step forward in Aurobindo Pharma's efforts to develop a potential alternative to denosumab. Denosumab is a monoclonal antibody used to treat various bone-related conditions, including osteoporosis and bone loss in cancer patients.

Implications for Aurobindo Pharma

This development could potentially position Aurobindo Pharma as a key player in the biosimilars market for bone health treatments. Biosimilars, which are highly similar versions of existing biologic drugs, often offer more affordable alternatives to patients and healthcare systems.

Market Potential

The successful development of a denosumab biosimilar could represent a significant opportunity for Aurobindo Pharma. Prolia® and Xgeva®, the reference products for BP16, are blockbuster drugs with substantial global sales. Entering this market could potentially boost Aurobindo's revenue and market presence in the coming years.

Next Steps

While the completion of the Phase 1 study is an important milestone, it's worth noting that the development of biosimilars is a complex and lengthy process. Aurobindo Pharma and Curateq Biologics will likely need to conduct further studies, including:

• Larger clinical trials
• Safety assessments
• Efficacy evaluations
• Immunogenicity studies

These additional steps are necessary to demonstrate the biosimilarity of BP16 to denosumab.

Conclusion

The successful progression of BP16 through its clinical development stages will be crucial for Aurobindo Pharma's growth strategy in the biosimilars segment. Investors and industry observers will be keenly watching for updates on the further development and potential market entry of this promising biosimilar candidate.

Aurobindo Pharma Limited 's wholly-owned subsidiary, CuraTeQ Biologics Private Limited, has announced a significant advancement in its biosimilar development program. The company has successfully completed a Phase 1 pharmacokinetics (PK) and pharmacodynamics (PD) study for BP16, its proposed biosimilar to the widely used osteoporosis and bone loss treatments, Prolia® and Xgeva® (denosumab).

Study Details and Results

The comprehensive study involved 204 healthy volunteers divided into three groups, comparing BP16 with reference products Prolia® obtained from both EU and US markets. Dr. Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, reported that BP16 demonstrated a pharmacokinetic profile nearly identical to the reference products. The study achieved key bioequivalence parameters within the established range of 80.00-125.00 percent for maximum serum concentration and area under the curve.

Dr. Prajapati further noted, "Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product."

Mechanism of Action and Applications

Denosumab, the active ingredient in BP16, targets the RANK ligand (RANKL), a crucial protein in the lifecycle of osteoclasts—cells responsible for breaking down bone. This mechanism makes denosumab effective in treating various conditions related to bone loss, including:

• Osteoporosis in postmenopausal women
• Bone metastases from cancers
• Cancer treatment-related bone health issues

Future Prospects and Ongoing Studies

With the successful completion of the Phase 1 study, CuraTeQ Biologics is now focusing on its ongoing Phase 3 study. Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics, expressed optimism about the progress:

"This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025. We aim to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year."

About CuraTeQ Biologics

CuraTeQ Biologics, a wholly-owned subsidiary of Aurobindo Pharma Limited, is a global biopharmaceutical company based in Hyderabad, India. The company's mission is to improve patient well-being by providing access to high-quality, cost-effective biosimilars. CuraTeQ's pipeline consists of fourteen biosimilars, primarily targeting immunology and oncology segments.

This development marks a significant step for Aurobindo Pharma in the competitive biosimilars market, potentially offering a more affordable alternative to established osteoporosis and bone loss treatments in the future.