Exemptia® World’s first biosimilar of Adalimumab, has been launched in SL
Access to this therapy will impact thousands of people suffering from auto immune disorders like rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel diseases such as crohn’s disease, & ulcerative colitis and plaque psoriasis & hidradenitis supprativa.
After more than a decade-long wait, the revolutionary therapy that provided a new lease of life to millions of patients suffering from rheumatoid arthritis and other auto immune disorders globally is now accessible to patients in Sri Lanka. Zydus has launched the biosimilar of Adalimumab – the world’s largest selling therapy. Developed by the researchers at the Zydus Research Centre, the biosimilar has been approved by the National Medicines Regulatory Authority of Sri Lanka and marketed under the brand name “Exemptia” to treat auto immune disorders.
This novel non-infringing process for Adalimumab and a novel non-infringing formulation have been researched, developed and produced by scientists at the Zydus Research Centre. This biosimilar is the first to be launched by any company in the world and is a ‘fingerprint match’ with the originator in terms of safety, purity and potency of the product.
Adalimumab, the fully human anti-TNF alpha monoclonal antibody, was first approved globally in 2002 and has since then been the preferred therapy to treat patients suffering from auto immune disorders. However, the therapy was not available to patients in Sri Lanka. It is estimated that more than 0.2 million patients in Sri Lanka suffer from these chronic conditions which progressively deteriorate and lead to lifelong pain and in some cases, even disability.
This therapy will offer a new lease of life to thousands of patient in Sri Lanka who have not had access to this therapy so far.
Biosimilars are biological products that are ‘similar’ or ‘highly similar’ to the reference medicinal products (originator products) following the EMA (European Medicines Agency), & FDA (Food and Drug Administration, USA) regulatory guidelines. Biosimilars have a similar level of efficacy and safety compared to that of the originator products and provide additional advantage to patients in terms of affordability and accessibility.
Exemptia is given as a 40 mg subcutaneous injection once every alternate week. Patients normally would have to take the treatment for six months. It has been clinically observed that the therapy is able to arrest the degeneration and the patient goes into remission – which means the auto immune disorder is under control and the patient is able to live a life without pain and can actually lead a fully active life.For more information, please visit www.exemptia.com