Theramex Announces an Agreement with Enzene Biosciences Limited for the Development and Commercialisation of Tocilizumab, a Biosimilar for the Treatment of Rheumatoid Arthritis
23.12.2021 17:06:00 EET | Business Wire | Press release
Theramex, a leading global speciality pharmaceutical company dedicated to women’s health, has entered into an agreement with Enzene Biosciences Limited to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab, in combination with Methotrexate (MTX), is indicated for the treatment of rheumatoid arthritis. It is planned to be commercialised from 2026 in Europe, the UK, Switzerland, and Australia.
Theramex’s Tocilizumab product will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors. The reference product RoActemra® is indicated for the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with methotrexate; moderate to severe RA adult patients who have not responded well/intolerant to DMARDs or Anti-TNFs; active systemic juvenile idiopathic arthritis in patients 1 year of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids; juvenile idiopathic polyarthritis in patients 2 years of age and older unresponsive to MTX; treatment of Giant Cell Arteritis in adults; and chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.
Rheumatoid arthritis is a chronic condition that causes pain, swelling and stiffness in the joints. The condition usually affects the hands, feet and wrists. There may be periods where symptoms become worse, known as flares. A flare can be difficult to predict, but with treatment it's possible to decrease the number of flares and minimise or prevent long-term damage to the joints. Some people with rheumatoid arthritis also experience problems in other parts of the body, or more general symptoms such as tiredness and weight loss1.
“Rheumatoid arthritis affects more women than men, so the addition of this biosimilar drug to our existing Rheumatology portfolio continues our strategic determination to improve access and affordability of important treatments for women. We are excited to expand our focus in Rheumatology to now include rheumatoid arthritis to help even more patients with bone diseases and joint pain”, said Theramex CEO Robert Stewart .
Dr. Himanshu Gadgil, Enzene's Whole Time Director said, "The development of Enzene’s Tocilizumab, through our innovative efforts in the manufacturing of monoclonal antibodies, marks another highlight in a series of endeavours driven by our mission to provide affordable and expanded access to crucial medicines. Our partnership with Theramex bolsters our mission to bring affordable healthcare to patients across the world”.
About Theramex
Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. We support women at every stage of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Our commitment is to listen to and understand our patients, serve their needs and offer healthcare solutions to help improve their lives. Our vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through every stage of life.
About Enzene Biosciences Ltd.
Enzene is an innovation-driven biotech company, a subsidiary of Alkem Laboratories Ltd. (One of the top five pharmaceutical companies in India*) located in Pune, India. Enzene's focus lies in producing biosimilars, novel biologics, synthetic peptides and phytopharmaceuticals. Enzene also offers a range of biologics CDMO and CMO services.
(*as per the latest IQVIA data of MAT July 2021)
For more information on Enzene Biosciences Ltd., please visit www.enzene.com
For more information on Alkem Laboratories Ltd., please visit www.alkemlabs.com
1 https://www.nhs.uk/conditions/rheumatoid-arthritis/
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211223005258/en/
Contact information
Theramex
Jesús López | Associate Director, Communication & Digital | Jesus.Lopez@Theramex.com
Enzene Biosciences Ltd.
For media enquiries,
Dr. Tarun Chawla
Head - Business Development & Business Operations
Enzene Biosciences Ltd.
For any further enquiries, please reach out to: bd@enzene.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Pelago Bioscience Acquires RG Discovery, Forming an Integrated Drug Discovery Partner Spanning Biology and Chemistry15.6.2026 10:00:00 EEST | Press release
Pelago Bioscience, a specialist drug discovery focused contract research organization (CRO), known for its industry-leading cell-based target engagement assays, is pleased to announce the acquisition of RG Discovery, and thereby adding deep expertise in medicinal chemistry, custom synthesis, and integrated drug discovery. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260615340933/en/ Michael Dabrowski, Chief Executive Officer of Pelago Bioscience By combining Pelago Bioscience's biology-focused capabilities with RG Discovery's chemistry expertise, the enlarged platform will enable drug discovery teams to accelerate decision-making, streamline workflows, and advance programs more efficiently from hit identification through lead optimization. "Drug discovery increasingly requires seamless integration between chemistry and biology," said Michael Dabrowski, Chief Executive Officer of Pelago Bioscience. "By bringing RG Discovery
LTM Launches BlueVerse™ for iRun to Outcreate Managed Services in the Agentic AI Era15.6.2026 09:10:00 EEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today announced the launch of BlueVerse™ for iRun, an AI-native managed services model designed to transform traditional IT operations into a resilient, intelligent, and outcome-driven operating model. As enterprise environments grow more complex—spanning hybrid cloud, SaaS, and AI-driven ecosystems—traditional managed services models are increasingly constrained by siloed teams, static processes, and effort-led scaling. BlueVerse for iRun addresses this shift by moving beyond headcount-based delivery to a platform-led approach powered by agentic AI, knowledge convergence, and process-as-code. Built on the BlueVerse ecosystem, iRun creates a unified intelligence layer that brings together enterprise data, telemetry, workflows, and operational context—enabling AI to reason across systems, identify root causes, and execute actions within governed guardrails. iRun combines AI agents and human expertise to shift opera
Azafaros to Present at BIO International Convention 202615.6.2026 08:00:00 EEST | Press release
Azafaros, a private company building a portfolio to become a leader in lysosomal storage disorders (LSDs), focused on addressing neurological symptoms, today announced that it will present at the 2026 BIO International Convention taking place in San Diego, USA, from June 22-25. The company’s presentation is scheduled for Monday, June 22 at 4:30 PM in Theater 4. The presentation will highlight Azafaros’ progress in developing nizubaglustat, its lead investigational compound for the treatment of rare lysosomal storage disorders with neurological involvement, including GM1 and GM2 gangliosidoses (GM1/GM2) and Niemann-Pick type C disease (NPC). Nizubaglustat is currently in two Phase 3 registrational studies (NAVIGATE) treating patients with GM1/GM2 and NPC and expects to report topline data from the studies in 2028. “BIO provides an important opportunity to update our progress as we continue advancing nizubaglustat through late-stage clinical development,” said Stefano Portolano, CEO at A
Teledyne FLIR Defense Launches Black Recon™ Autonomous Micro-Drone15.6.2026 07:05:00 EEST | Press release
Teledyne FLIR Defense, part of Teledyne Technologies Incorporated (NYSE: TDY), today announced at Eurosatory the market launch of Black Recon™, an autonomously launched micro-drone system that delivers continuous, untethered reconnaissance from military vehicles and fixed installations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260614388428/en/ Teledyne FLIR Defense announced at Eurosatory the market launch of Black Recon™, an autonomously launched micro-drone that delivers continuous, untethered reconnaissance from military vehicles and fixed installations. Black Recon allows crews to launch, operate, recover, and recharge up to three UAS without leaving their platform, reducing operator risk. Designed for vehicle integration, Black Recon allows crews to launch, operate, recover, and recharge up to three unmanned aerial systems without leaving their platform, reducing risk and accelerating decision-making. “Black Recon
OM Pharma to Unveil the Largest Multi-Country Real-World Evidence Study on Broncho‑Vaxom® (OM‑85) for RTI Prevention at EAACI 202614.6.2026 11:00:00 EEST | Press release
OM Pharma will reveal preliminary results from the REACH study at the European Academy of Allergy and Clinical Immunology (EAACI) Congress. REACH is the first and largest multi-country real-world evidence (RWE) study to date evaluating the impact of Broncho-Vaxom® in patients with recurrent respiratory tract infections (RTIs).1,2 The findings offer critical new clinical evidence of the therapy's effectiveness in everyday clinical practice. In a real-world cohort of 15,794 paediatric (aged >1 year), adolescent, adult and elderly patients in China, Italy, and Belgium, Broncho-Vaxom® was associated with reductions in RTI recurrence and healthcare utilisation at 12 and 24 months after treatment initiation, compared with the 12 months prior to starting the therapy.1 “The REACH real-world evidence study shows that Broncho-Vaxom® can significantly reduce infections requiring medical visits across age groups and co-morbidities,” said Anna Thomas, Chief Scientific Officer at OM Pharma. “Recurre
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom