Amneal's Strategic Expansion in the Biosimilars Space: A High-Value Play on $5.3B Market with mAbxience Partnership

The U.S. biosimilars market is undergoing a transformative phase, driven by patent expirations, regulatory tailwinds, and escalating demand for cost-effective therapies. With the market projected to grow at a compound annual growth rate of 17.1% from $22.59 billion in 2025 to $93.52 billion by 2034, Amneal Pharmaceuticals has positioned itself as a strategic contender through its partnership with mAbxience. This collaboration, , underscores Amneal's ambition to ascend as a top-five player in the U.S. biosimilars landscape.

Market Dynamics and Strategic Rationale

The biosimilars sector is being reshaped by the expiration of key biologic patents, including Amgen's Prolia® and XGEVA®, which together generated $5.3 billion in annual sales. Regulatory advancements, such as the 's emphasis on cost containment, further amplify the urgency for affordable alternatives. Amneal's partnership with mAbxience-a leader in biosimilar development-provides a critical edge. By leveraging mAbxience's expertise in manufacturing and development, Amneal secured FDA approvals for two denosumab biosimilars in 2025. This partnership not only accelerates time-to-market but also mitigates the high capital expenditures typically associated with biosimilar development.

Amneal's strategy aligns with its broader vision to expand its oncology portfolio. The company's biosimilars pipeline now includes six products across eight presentations by 2027, with five additional launches planned between 2026 and 2027. This aggressive expansion mirrors the success of its generics business, , driven by strong performance in complex product lines.

Competitive Positioning: Navigating a Crowded Market

The U.S. biosimilars market is dominated by Sandoz, Pfizer, and Amgen, which . Sandoz, , has already launched Jubbonti® (Prolia biosimilar) and Wyost® (XGEVA biosimilar), priced at 14.5% and 7% discounts, respectively, compared to the reference products. Amgen, the originator of denosumab, has countered with its own biosimilars, including Pavblu™ (aflibercept biosimilar) and Bkemv™ (eculizumab biosimilar), while also defending its market through aggressive R&D investments.

Amneal's entry into this competitive arena is bolstered by its cost structure and partnership model. While Sandoz and Amgen rely on in-house development, Amneal's collaboration with mAbxience allows it to focus on commercialization, reducing operational risks. Additionally, the denosumab biosimilars market has already demonstrated pricing pressures, .

Amneal's ability to penetrate this market will depend on its pricing strategy and speed of adoption, but its prior success with the bevacizumab biosimilar ALYMSYS®-approved in 2022-provides a proven commercialization framework.

Growth Projections and Long-Term Potential

Amneal's biosimilars segment , , signaling strong market acceptance. Analysts project the global biosimilars market , , with oncology applications-Amneal's focus area-accounting for 25% of the 2025 market share. The company's pipeline, which includes biosimilars for Xolair (omalizumab) and other high-value biologics, positions it to capitalize on future patent expirations.

However, challenges remain. Sandoz's dominance in manufacturing and Amgen's first-mover advantage in biosimilar development could limit Amneal's market share. Yet, Amneal's partnership model and focus on niche therapeutic areas (e.g., bone diseases and oncology) offer differentiation. As the market evolves, pricing transparency and regulatory clarity will be critical for Amneal to scale its biosimilars business effectively.

Conclusion

Amneal's strategic alliance with mAbxience represents a calculated move into a high-growth, high-margin segment of the biosimilars market. While Sandoz and Amgen maintain formidable positions, Amneal's agility, cost-efficient partnership, and focus on oncology and bone disease biosimilars position it as a compelling long-term investment. With the U.S. biosimilars market set to expand nearly fivefold by 2034, Amneal's ability to execute its pipeline and secure market share in the $5.3 billion denosumab segment could drive significant shareholder value.