Biocon (NSE: BIOCON) gains EU nod for Denosumab biosimilars Vevzuo and Evfraxy to target bone health market

Why has the European approval of Biocon Biologics’ Denosumab biosimilars attracted investor attention and regulatory significance?

Biocon Biologics Limited, a subsidiary of the Indian biopharmaceutical company Biocon Limited (NSE: BIOCON), has received marketing authorization from the European Commission for its biosimilars Vevzuo and Evfraxy, both referencing Denosumab. The decision, announced on July 3, 2025, allows commercial distribution across the European Union. This milestone marks a pivotal expansion into bone health for the biosimilars arm of Biocon, which has already established regulatory momentum across Europe and the United Kingdom over the past 18 months.

The announcement builds on the April 2025 positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). It also aligns with Biocon Biologics’ strategy to deepen its footprint in chronic disease biologics and specialty therapies. Analysts noted the news as a validation of the Indian biosimilars developer’s scientific and regulatory strength, especially as bone-related biologics continue to command significant clinical and commercial importance in aging European populations.

What do Vevzuo and Evfraxy target, and how do they align with unmet therapeutic needs in Europe’s aging population?

The two approved biosimilars offer distinct but complementary indications. Vevzuo is authorized for the prevention of skeletal complications in adults with advanced cancers involving bone, and for the treatment of unresectable or morbid giant cell tumor (GCT) of the bone in adults and skeletally mature adolescents. Meanwhile, Evfraxy is indicated for the treatment of osteoporosis in postmenopausal women and men, as well as bone loss due to hormone ablation in prostate cancer or long-term glucocorticoid therapy.

Both biosimilars are based on Denosumab, a fully human monoclonal antibody targeting the RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) protein. RANKL inhibition halts osteoclast activity—the cells responsible for bone resorption—resulting in improved bone mass and strength. This mechanism is clinically significant not only for osteoporosis but also for managing skeletal events in metastatic cancer cases.

Osteoporosis alone affects over 32 million people aged 50 and above across Europe, with women comprising 80% of cases, according to the International Osteoporosis Foundation. In the United Kingdom, one in five men over 50 are expected to break a bone due to osteoporosis, underscoring the urgent need for accessible treatment options. By entering this segment, Biocon Biologics taps into a high-burden disease category with sustained demand and limited biosimilar competition to date.

How does Biocon Biologics’ Denosumab biosimilar approval compare with other recent launches in Europe and the UK?

This is the third European Union approval for Biocon Biologics within 18 months and comes alongside two separate authorizations in the UK, signaling a period of accelerated regulatory activity. The biosimilars developer has clearly prioritized diversification beyond its early focus on diabetology and oncology, with the addition of bone health, immunology, and ophthalmology in its 20-asset pipeline.

In the current case, clinical comparability studies presented at ACR 2024 and WCO-IEF-ESCEO 2025 demonstrated equivalent efficacy, pharmacodynamics, safety, and immunogenicity versus reference Denosumab (marketed as Prolia and Xgeva). These data were foundational in securing CHMP’s favorable opinion in April 2025, leading to today’s authorization by the European Commission.

From a regulatory competitiveness standpoint, Biocon Biologics’ early entry into the Denosumab biosimilar race places it ahead of several Western peers. The approval also follows its established success in biosimilars for trastuzumab, pegfilgrastim, and insulin glargine, strengthening its reputation as one of the few non-Western players achieving end-to-end development, manufacturing, and commercialization in regulated markets.

What is the significance of this move in the broader biosimilars market and Biocon’s evolving global strategy?

The Denosumab biosimilars reinforce Biocon Biologics’ positioning as a fully integrated biosimilar developer, manufacturing at scale across India and Malaysia and delivering products to over 120 countries. The company serves an estimated 5.8 million patients annually and has pursued a strategy of aggressive international expansion post its acquisition of Viatris’ biosimilar business in 2022.

Investor sentiment has tracked positively to Biocon Biologics’ licensing and launch momentum in developed markets. Institutional observers suggest that the Denosumab milestone not only boosts Biocon’s revenue visibility but also provides an early-mover advantage in a niche where biologic prices have traditionally created reimbursement challenges for national health systems.

Moreover, the timing is strategic. As biologic patents for high-cost therapies expire, biosimilar developers capable of meeting stringent EU and U.S. quality thresholds are being seen as preferred partners for hospitals and insurance-driven healthcare systems. Biocon’s expanded EU portfolio—now covering multiple high-burden conditions—could deepen its commercial contracts across national procurement tenders.

How does the financial market view Biocon’s stock performance and valuation relative to this regulatory milestone?

As of July 3, 2025, Biocon Limited (NSE: BIOCON) traded at ₹369.15, reflecting a marginal gain of ₹0.60 or 0.16% over the previous close. The intraday high reached ₹372.55 while the volume-weighted average price (VWAP) was ₹370.31. The adjusted price-to-earnings (P/E) ratio stood at 35.66, slightly above the Nifty Pharma index average of 33.91, suggesting a valuation premium potentially attributable to its biosimilars momentum.

The market capitalization was recorded at ₹49,354 crore, with a free float market cap of ₹22,137 crore and traded volume of 4.37 lakh shares during the session. The delivery percentage—an indicator of long-term investor interest—stood at a robust 39.68%, pointing to institutional or patient capital engagement.

While the gains were modest following the announcement, institutional investors may be taking a wait-and-see approach to assess pricing dynamics and launch velocity across EU markets. Nonetheless, with Denosumab biosimilars priced well below reference products and reimbursement policies favoring biosimilars in countries like Germany, France, and Italy, a revenue uptick is anticipated in FY26.

What strategic outlook do experts project for Biocon Biologics after the Denosumab authorization?

According to institutional sentiment, Biocon Biologics now has a foothold in one of the most medically and commercially significant biologics categories in Europe. As reimbursement dossiers roll out across member states, the company is expected to actively engage in pricing negotiations and patient access programs to drive uptake.

Future outlook includes expanding the biosimilar’s reach to additional regulated markets, potentially Canada and Australia, followed by applications in Latin America and Southeast Asia. Given that Denosumab’s U.S. exclusivity expires soon, a Biologics License Application (BLA) or 351(k) submission in the United States is likely under preparation.

Meanwhile, Biocon Biologics continues to advance biosimilars in immunology, ophthalmology, and novel delivery systems, indicating long-term diversification beyond standard injectables. Its current 20-asset pipeline is also expected to yield additional Phase 3 completions in FY26–FY27, which could further drive valuations.

Industry observers have flagged Biocon Biologics as one of the few Asian players with a proven track record in securing EMA, MHRA, and FDA authorizations—an increasingly critical differentiator in global biosimilar contracting.