Theramex Announces an Agreement with Enzene Biosciences Limited for the Development and Commercialisation of Tocilizumab, a Biosimilar for the Treatment of Rheumatoid Arthritis
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
Aspect Announces CEO Leadership Transition and New Independent Board7.1.2026 01:13:00 EET | Press release
Aspect, a leading provider of cloud-based workforce management solutions, has announced a leadership transition, including the appointment of Jeff Kupietzky as Interim Chief Executive Officer and the formation of a new independent Board of Directors, marking an important next chapter for the company. As part of this transition, Darryl Kelly will step down as Chief Executive Officer and transition into a Strategic Advisor role, effective January 1, 2026. Darryl led Aspect through a pivotal period of transformation, helping reposition the business, refine its vision, and reinvigorate its innovation and execution. The company and its stakeholders thank Darryl for his leadership and contributions during a period of meaningful change. With Darryl continuing as Strategic Advisor, the organization retains continuity for employees, customers, and stakeholders. “Aspect is starting a new season, building upon the strong foundation we’ve created together,” said Darryl Kelly. “This transition is a
Brenus Pharma Reports Favorable Tolerability and Clinical Signals in Early Preliminary Results of First-In-Human Study for STC-1010 in Unresectable Metastatic Stage Colorectal Cancer (MSS CRC) Patients6.1.2026 22:00:00 EET | Press release
Brenus Pharma, a clinical stage biotechnology company unlocking the immune system in vivo to fight solid tumors, announced the successful completion of the first dose levels in its ongoing first-in-human study. The multi-center, open-label trial (NCT06934538) is a phase Ia/Ib study designed to evaluate safety, tolerability and preliminary clinical activity of STC-10101 in a first line setting. It will include in vivo analysis of immune and tumor dynamics during dose escalation of treatment and cohort extension to patients with unresectable locally advanced (stage IIIC, T4b) or unresectable metastatic (stage IV) MSS2 colorectal cancer (CRC). Early findings indicate that the first dose levels have been successfully completed with good overall tolerance and no-dose-limiting toxicities observed to date. “We are pleased to report that the safety profile observed to date is good and consistent with our expectations with no DLT,” said Paul Bravetti, CEO of Brenus Pharma. “Moreover, preliminar
SPIE, the International Society for Optics and Photonics, Announces Its 2026 Fellows6.1.2026 21:35:00 EET | Press release
SPIE, the international society for optics and photonics, welcomes 40 Members as new Fellows of the Society in the 2026 cohort. They join their Fellow Member colleagues in being honored for their excellent technical achievements, as well as for their substantial service to the optics and photonics community and to SPIE. Fellows are Members of the Society who have made significant scientific and technical contributions in the multidisciplinary fields of optics, photonics, and imaging. Since the Society's inception in 1955, more than 1,800 SPIE Members have become Fellows. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260106630672/en/ SPIE, the international society for optics and photonics, announces its 2026 Fellows This year’s inductees are high-profile leaders in academia, industry, and government, many of whom are particularly prominent in their support of the optics and photonics community and mentorship of others. “It’
Chemelex Adds Electric Heat Trace Group Ltd.’s SmartTrace Monitoring Platform to its Heat Tracing Portfolio6.1.2026 21:00:00 EET | Press release
Chemelex, a global leader in electric thermal and sensing solutions, today announced the successful completion of its acquisition of substantially all the assets and ongoing operations of Electric Heat Trace Group Ltd. (EHT Group), headquartered in Ontario, Canada. This strategic move marks an exciting start to the new year and reinforces Chemelex’s commitment to delivering smarter, data-driven solutions for industrial heat trace systems. EHT Group is a recognized innovator in heat trace management, offering advanced software, integrated controller solutions, wireless communication modules, and comprehensive field services. Its flagship platform, SmartTrace, is a robust solution available in both cloud-based and on-premises deployments that enables predictive maintenance, minimizes downtime, and provides secure remote monitoring—helping customers achieve greater reliability and operational efficiency. This endeavor will help Chemelex support greater operational efficiencies for our cus
ZIIHERA Plus TEVIMBRA and Chemotherapy: A Potential New Standard for First-Line HER2+ Advanced GEA6.1.2026 20:30:00 EET | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced full results from the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), a HER2-targeted bispecific antibody, in combination with chemotherapy, with and without PD-1 inhibitor TEVIMBRA® (tislelizumab), as a first-line treatment for HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). These data, including the first interim overall survival (OS) analysis, will be presented as a Late-Breaking Abstract Oral Presentation (#LBA285) at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) on January 8, 2026, from 8:57- 9:07 a.m. PST. HERIZON-GEA-01 met the dual primary endpoint of progression-free survival (PFS), demonstrating statistically significant and clinically meaningful improvements in both experimental arms compared to the control arm. The addition of TEVIMBRA to ZIIHERA and chemotherapy also sho
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