Wednesday 26 July 2017

Biosimilars: The New Solution to Conventional Drugs

Biosimilar products are split into recombinant non-glycosylated proteins, which include insulin, human growth hormones, among others and recombinant glycosylated proteins that include erythropoietin and follitropin, among others. Growing incidences of cancer, blood disorders, growth hormone deficiency, etc. are predicted to drive the biosimilars market over the forecast period (2016 to 2024).  

Amgen, Inc., recently unveiled their new biosimilar version of AbbVie Inc.’s ABBV rheumatoid arthritis (RA) medicine “Humira”, which has received an approval by the European Commission (EC).  The drug received an approval from U.S. in September 2016, under the name “Amjevita” (adalimumab-atto).

Amjevita is a biosimilar to the drug “Humira” (adalimumab), used to treat other inflammatory diseases namely ankylosing spondylitis (an arthritis that affects the spine), psoriatic arthritis, adult Crohn’s,rheumatoid arthritis (RA), ulcerative colitis (UC), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), plaque psoriasis (PsO)  psoriatic arthritis (PsA), and in patient as a monotheray or combination with methotrexate.

Amjevita is used to help treat moderately to severely active polyarticular juvenile idiopathic arthritis in children four years and above. According to the FDA, Amjevita has been approved as a biosimilar, but not as interchangeable product. FDA approved the drug based on the review of evidences that comprised structural and functional characterization, human pharmacokinetic, pharmacodynamics data, clinical immunogenicity data and other safety and effectiveness data. 

The biosimilars market is expected to reach USD 41.7 billion by 2024; according to a new report by Grand View Research, Inc. Biologics are rapidly approaching patent expiration, can drive the market over the coming years.

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