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
Vertex to Present New Data on ALYFTREK ® at the North American Cystic Fibrosis Conference9.10.2026 20:15:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new interim data from the ALYFTREK® (vanzacaftor/tezacaftor/deutivacaftor) 2 to 5 years old open-label extension study, highlighting recovery of exocrine pancreatic function in some children in that age group, allowing those children to discontinue pancreatic enzyme replacement therapy (PERT). Pancreatic exocrine insufficiency in children with cystic fibrosis (CF) was previously believed to be irreversible. These data were presented at the North American Cystic Fibrosis Conference (NACFC). “The data presented at NACFC underscore the safety and efficacy of our CF medicines in the real world and in clinical trials in younger age groups. The data from the Phase 3 open-label study in 2 to 5 year olds evaluating exocrine pancreatic function represent a profound shift in how we understand the benefits of treating cystic fibrosis in its earliest stages,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Devel
Verdant Rock Receives A (low) Financial Strength Rating from Morningstar DBRS, Adding a Second International Investment-Grade Assessment9.10.2026 17:00:00 EEST | Press release
Verdant Rock Limited, a Bermuda Monetary Authority-regulated Class 3B insurance company, has received an A (low) Financial Strength Rating from Morningstar DBRS. The rating reflects Verdant Rock’s financial strength and its capacity to meet policyholder obligations as an investment-grade financial guarantor for Emerging Markets credit. Morningstar DBRS is a global credit rating agency with coverage across North America, Europe, Asia, and Latin America. Its assessment of Verdant Rock reflects the company’s strong projected earnings ability, robust risk profile, sound liquidity, and good capitalization. Morningstar DBRS also assigned an A (low) Issuer Rating to Verdant Rock. The rating follows Verdant Rock’s BBB+ Long-Term Insurer Financial Strength Rating with a Stable Outlook from Fitch Ratings, assigned on 12 June 2026. Verdant Rock now holds Financial Strength Ratings from both Fitch Ratings and Morningstar DBRS, providing counterparties with dual-agency confirmation of the company’s
Tecnotree Named a Visionary in the Inaugural 2026 Gartner® Magic Quadrant™ for CSP AI-Enabled Marketing and Sales Solutions9.10.2026 16:17:00 EEST | Press release
Tecnotree, a global digital platform and services leader for AI, 5G, and cloud-native technologies, today announced that Gartner has positioned it as a Visionary in the first-ever Magic Quadrant for AI-Enabled CSP Marketing and Sales Solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261009905430/en/ Tecnotree Named a Visionary in the Inaugural 2026 Gartner® Magic Quadrant™ for CSP AI-Enabled Marketing and Sales Solutions A new category for a new operating model. CSPs are fighting saturated markets, rising acquisition costs, and accelerating churn. They are responding with AI-driven automation across the full revenue cycle, from segmentation and campaigns to lead management, CPQ, and renewals, increasingly executed by autonomous agents. According to us, Gartner creation of this Magic Quadrant confirms the shift has moved from pilot to boardroom priority. According to Gartner, Visionaries "understands where the market
Positive New Data on Corcym’s Perceval Plus Sutureless Aortic Heart Valve Encompasses up to 7-Year Follow-up9.10.2026 16:15:00 EEST | Press release
Corcym, a global medical device company dedicated to cardiac surgery, today announced that positive mid-term data from a sub-analysis of its Perceval Plus sutureless aortic heart valve as part of its MANTRA clinical trial was featured in an oral presentation today at the annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS). The study is the longest follow-up available for Perceval Plus and the FREE tissue treatment from an international multicenter study, and demonstrated excellent durability, safety and quality of life improvements. Perceval Plus is the only sutureless and collapsible aortic surgical heart valve. Its unique design performs in any surgical scenario and is optimal for endoscopy and robotics. The valve features the company’s FREE next generation tissue treatment addressing the two main causes of calcification, phospholipids and aldehydes. Its proprietary LANCELOT advanced manufacturing process includes zero-pressure shaping and laser cutting of
Ada earns AWS Travel and Hospitality Competency for resolving traveler issues at scale9.10.2026 16:00:00 EEST | Press release
Ada, the pioneer in Agentic Customer Experience, today announced it has achieved the Amazon Web Services (AWS) Travel and Hospitality Competency. The designation recognizes Ada as an AWS Partner with demonstrated technical proficiency and proven customer success helping travel and hospitality brands resolve customer issues at scale. Ada joins a select group of 58 AWS Partners holding the competency, and it reflects a shared commitment to helping travel brands deliver service that holds up on their busiest, most unpredictable days. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261009673638/en/ Ada earns AWS Travel and Hospitality Competency for resolving traveler issues at scale "Travel is where agentic customer service gets tested hardest. Demand spikes without warning, policies change by the hour, and customers are often stressed and far from home," said Mike Murchison, CEO and co-founder of Ada. "Our airline and hospitali
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