RDY & Bio-Thera Ink Deal for JNJ's Stelara/Simponi Biosimilar

Dr. Reddy’s Laboratories RDY and China-based Bio-Thera Solutions announced that they have entered into commercialization and license agreements for BAT2206, a proposed biosimilar of Johnson & Johnson’s JNJ Stelara (ustekinumab), and BAT2506, a proposed biosimilar candidate of JNJ’s Simponi (golimumab).

The impending licensing deal is expected to significantly enhance Dr. Reddy’s biosimilar portfolio across emerging markets. By capitalizing on its well-established commercial presence, RDY aims to bridge the gap in patient access to affordable medicines, addressing critical healthcare needs in these regions.

Meanwhile, Bio-Thera plans to utilize Dr. Reddy’s extensive resources and deep expertise in the generics industry to facilitate the availability of BAT2206 and BAT2506 in Southeast Asia. This collaboration is poised to accelerate patient access to high-quality biosimilars, reinforcing both companies' commitment to expanding healthcare solutions globally.

BAT2206, the proposed biosimilar to J&J’s Stelara, is a human monoclonal antibody with a unique mechanism of action that has potential in treating Crohn's disease and ulcerative colitis, among many other autoimmune diseases. JNJ’s Stelara is approved for treating various immune-related conditions in the EU. These include moderate to severe plaque psoriasis in patients over six years old, active psoriatic arthritis (alone or with methotrexate), and moderately to severely active Crohn’s disease and ulcerative colitis in adults who have not responded to or cannot receive other treatments.

On the other hand, BAT2506, the proposed biosimilar to J&J’s Simponi, is also a human monoclonal antibody, with a unique mechanism of action. JNJ's Simponi is approved in the United States for treating moderate to severe rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, and moderate to severe ulcerative colitis. It also carries a boxed warning for serious infections and cancer risks.

Terms of RDY’s Licensing Deal With Bio-Thera

Under the agreement, Bio-Thera will oversee the development, manufacturing, and supply of BAT2206 and BAT2506. Dr. Reddy’s will handle regulatory approvals and commercialization in its licensed territories across Southeast Asia, including Cambodia, Indonesia, Malaysia, the Philippines, Thailand, and Vietnam.

Additionally, Dr. Reddy’s will have exclusive commercial rights to BAT2206 in Colombia.

RDY’s Recent Efforts to Boost Biosimilar Portfolio

Dr. Reddy’s has been undertaking several strategic measures to diversify its generics portfolio. Earlier in March, RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the approval of AVT03, a proposed biosimilar of Amgen’s AMGN Prolia (denosumab) and Xgeva (denosumab) for review.

The biologic license application was submitted under the 351(k) pathway, which is the FDA’s biosimilar application process. AVT03 is a human monoclonal antibody developed by Alvotech.

Amgen's Prolia treats osteoporosis in postmenopausal women at high risk of fractures, especially when other treatments are ineffective. AMGN’s Xgeva helps prevent fractures, spinal cord compression and the need for bone-related surgery or radiation in patients with multiple myeloma or bone metastases from solid tumors.

Subject to approval, RDY/ALVO’s AVT03 could significantly enhance patient access to affordable treatment options for osteoporosis and other bone-related conditions. AVT03’s approval would align with broader efforts to expand the availability of high-quality biologic medicines. Given the high cost of branded drugs, a biosimilar alternative could provide substantial financial relief to patients and healthcare systems. Additionally, with osteoporosis affecting millions across the United States, the introduction of AVT03 could improve treatment accessibility for a large patient population in need of effective bone health therapies.

Dr. Reddy’s and Alvotech signed a license and supply agreement for AVT03 in 2024, outlining their respective roles in bringing the biosimilar to market. Per the agreement, Alvotech is responsible for the development and manufacturing of AVT03, while Dr. Reddy’s is tasked with its registration and commercialization in key markets, including the United States.

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