Dr Reddys Laboratories (NSE: DRREDDY) has announced a groundbreaking development in the fight against HIV. The Indian pharmaceutical giant, along with Hetero Labs, is set to introduce generic versions of lenacapavir, a revolutionary HIV prevention drug, at a fraction of the original cost.

Affordable HIV Prevention

The generic versions of lenacapavir will be priced at approximately $40.00 per year, with distribution scheduled to begin in 2027. This pricing strategy aims to match the cost of oral Pre-Exposure Prophylaxis (PrEP) medications, potentially making HIV prevention more accessible to millions in low-income countries.

Comparison with Original Drug

The original drug, developed by Gilead Sciences and marketed as Yeztugo, is a twice-yearly injection that has demonstrated nearly 100% effectiveness in preventing HIV during extensive trials. However, its annual cost in the United States is around $28,000.00, making it prohibitively expensive for many patients, especially in lower-income regions.

Licensing and Support

Dr Reddy's and Hetero Labs have received royalty-free licenses from Gilead Sciences to manufacture and distribute the drug in 120 low- and lower-middle-income countries. This initiative is supported by several global health organizations:

• Unitaid
• Clinton Health Access Initiative
• Wits RHI (supporting Dr Reddy's efforts)
• Gates Foundation (working with Hetero)

Potential Impact

Experts estimate that the long-term demand for this HIV prevention drug could reach 10 million people or more. The introduction of affordable generics is crucial for expanding access to this highly effective prevention method.

Looking Ahead

The availability of these generic versions starting in 2027 could mark a significant milestone in global HIV prevention efforts. By drastically reducing the cost of a highly effective prevention method, Dr Reddy's and Hetero Labs are poised to make a substantial impact on public health in low- and lower-middle-income countries.

This development aligns with Dr Reddy's commitment to providing affordable healthcare solutions and could potentially reshape the landscape of HIV prevention in resource-limited settings.

Dr Reddys Laboratories , a global pharmaceutical company headquartered in Hyderabad, India, has achieved a significant milestone in its biosimilar development program. The company announced that it has received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar of denosumab.

Key Highlights

• AVT03 is a biosimilar candidate to Prolia® and Xgeva®, both denosumab products
• The CHMP positive opinion is a crucial step in the European approval process
• Upon approval, Dr. Reddy's will market the biosimilar under the tradenames Acvybra® and Xbonzy®

Regulatory Pathway

The positive CHMP opinion will now be reviewed by the European Commission (EC). Following this review, a decision will be made on granting marketing authorization in the European Economic Area (EEA), which includes the European Union member countries, Norway, Iceland, and Liechtenstein.

Dr. Reddy's also plans to submit a separate Marketing Authorisation Application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) through the reliance route under the International Recognition Procedure (IRP).

About AVT03

AVT03 is a human monoclonal IgG2 antibody and biosimilar candidate to Prolia® and Xgeva®. Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, reducing osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction.

Commercial Strategy

Dr. Reddy's entered into a license and supply agreement with Alvotech for the commercialization of AVT03. Under this agreement:

• Alvotech will develop and manufacture AVT03
• Dr. Reddy's is responsible for registration and commercialization in applicable markets, including the U.S. and Europe
• Dr. Reddy's commercialization rights are exclusive for the U.S. and semi-exclusive for Europe and the UK

Potential Market Impact

The positive CHMP opinion for AVT03 represents a significant advancement in Dr. Reddy's biosimilar portfolio. Denosumab is a widely used medication for treating osteoporosis and preventing skeletal-related events in patients with bone metastases. The introduction of a biosimilar version could potentially increase access to this important therapy and offer cost savings to healthcare systems.

As Dr. Reddy's continues to expand its presence in the biosimilar market, this development underscores the company's commitment to providing affordable and innovative medicines globally. The company's growing biosimilar portfolio, which now includes six commercial products marketed in India and other countries, positions it as a significant player in the evolving biosimilar landscape.

With the potential approval of AVT03, Dr. Reddy's is poised to strengthen its foothold in the European pharmaceutical market and further its mission of accelerating access to high-quality, affordable medications for patients worldwide.