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Enbrel against autoimmune diseases

Along with a Korean manufacturer, the U.S. pharmaceutical giant Merck & Co. are to create a biosimilar version of a popular drug for treatment of autoimmune diseases. They are going to develop and bring to market the drug called HD203, which is a biosimilar version of Enbrel (Etanercept), created by Amgen and Pfizer.
 
Enbrel is an immunosuppressant injection drug for subcutaneous injection in vials or provided syringes, permitted by Food and Drug Administration as a means for treatment of rheumatoid arthritis and psoriasis.
 
Under the covenant, Hanwha and Merck will work together to promote a biosimilar version of the Korean drug. Merck is responsible for clinical trials and manufacturing, with the right to sell Enbrel in the world’s markets. In Korea and Turkey, selling rights are owned by Hanwha. Financial terms are not disclosed. However, the company reports it includes all commercial payments and royalties for Hanwha. Earlier, Enbrel was announced to enter the top ten world blockbusters that are cheaper due to competition of generics.
 
In North America, Etanercept is sold jointly by Amgen (UK) and Wyeth, in the form of powder or solution. Wyeth owns exclusive distribution rights to distribute Enbrel outside of North America, except Japan, where the rights belong to Takeda Pharmaceuticals (UK).
 
Etanercept is a TNF inhibitor. TNF represents a cytokine produced by monocytes and macrophages, two types of white blood cells. TNF stimulates immune response by increasing transport of leukocytes to sites of inflammation, as well as additional molecular mechanisms that trigger and amplify inflammation. Its inhibition with Enbrel reduces inflammatory process, which is particularly beneficial in treatment of autoimmune diseases.
 
Indication
 
Treatment of moderate to severe active rheumatoid arthritis (in combination with methotrexate or as monotherapy).
 
Treatment of moderate to severe active poly-articular juvenile idiopathic arthritis in patients aged 2 years and older.
 
Reduction of symptoms and slowing down the progression of structural damage in active arthritis; improving function in patients with psoriatic arthritis.
 
Reduction of symptoms in patients with active ankylosing spondylitis.
 
Treatment of adult patients (aged 18 years and older) with chronic moderate to severe psoriasis (with presence of plaques), preparing for systemic or photo therapy.
 
Enbrel: Dose schedule
 
The daily dose for adults is 50 mg; for children aged 2 to 17 years - 800 mg / kg (maximum 50 mg / week.). Dose frequency and duration of use depend on indications and tolerability.


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