Bio-Thera Solutions Expands Partnership With Dr. Reddy's Through An Exclusive Commercialization And License Agreement For BAT2306, A Proposed Biosimilar Candidate To Cosentyx (Secukinumab), In Southeast Asia

Bio-Thera Solutions, a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that it has entered into an exclusive commercialization and license agreement with Dr. Reddy’s Laboratories Ltd., for BAT2306, a proposed biosimilar candidate to Cosentyx (secukinumab).

Under the terms of the agreement, Bio-Thera will be responsible for developing, manufacturing, and the supply of BAT2306. Dr. Reddy’s will be responsible for seeking regulatory approvals and commercialization in the licensed territories of Southeast Asia, including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand and Vietnam.

“Bio-Thera is proud to expand its partnership with Dr. Reddy’s in Southeast Asia”, said Bert Thomas, Senior Vice President of Business Development of Bio-Thera. “It is important to bring biosimilars to patients in Southeast Asia to increase access to innovative therapeutics at an affordable price and Dr. Reddy’s strong market presence in the region will maximize patient access to our biosimilar.”

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said: “Our extended partnership with Bio-Thera reaffirms our commitment toward advancing high-impact therapeutic solutions. The collaboration on Secukinumab marks another step in expanding our biosimilar presence across Emerging Markets and improving access to advanced treatments for patients worldwide.”

About BAT2306 (Secukinumab)
Secukinumab is a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A.

In the US, secukinumab is prescribed for the following indications: 1) moderate to severe plaque psoriasis (PsO) in patients 6 years and older who are candidates for systemic therapy or phototherapy, 2) active psoriatic arthritis (PsA) in patients 2 years of age and older, 3) adults with active ankylosing spondylitis (AS), 4) adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, 5) active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older, 6) adults with moderate to severe hidradenitis suppurativa (HS).

In EU, secukinumab is used to treat the following conditions: 1) moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, 2) moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy, 3) active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy, 4) active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate, 5) Axial spondyloarthritis (axSpA), 6) active ankylosing spondylitis in adults who have responded inadequately to conventional therapy, 7) active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs (NSAIDs), 8) Juvenile idiopathic arthritis (JIA), 9) active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy, 10) active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.

About Bio-Thera Solutions
Bio-Thera Solutions, Ltd., a leading innovative, global biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular, eye diseases, and other severe unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next generation antibody discovery and engineering, the company has advanced multiple candidates into late-stage development, including five approved products: QLETLI (adalimumab) and BETAGRIN (bevifibatide citrate) Injection in China, STARJEMZA (ustekinumab) in the US and Usymro (ustekinumab) in EU, and TOFIDENCE/BAT1806 (tocilizumab) and AVZIVI (bevacizumab-tnjn) in the US and in EU, a/k/a POBEVCY in China. In addition, the company has more than 20 promising candidates in clinical trials, focusing on immuno-oncology in the post-PD-1 era and targeted therapies such as antibody-drug conjugates (ADCs). For more information, visit www.bio-thera.com/en/.

About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, visit www.drreddys.com.