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FDA Staff Backs Adalimumab (Humira) Biosimilar

Top-selling medication will lose RA patent in December

Staff members at the FDA have concluded that Amgen’s biosimilar form of adalimumab (Humira, AbbVie), the world’s top-selling medication, is similarly potent and safe as the original product, according to a Reuters report. The announcement precedes a meeting on July 12 of the FDA’s Arthritis Advisory Committee, which will decide whether to recommend approval of Amgen’s cheaper version of adalimumab, called ABP 501.

In documents posted on the FDA’s website, staff scientists said their review of data from clinical trials suggested that ABP 501 and adalimumab are “highly similar” in terms of safety, purity, and potency in the studied indications of rheumatoid arthritis (RA) and plaque psoriasis.

During its meeting, the FDA’s advisory committee will discuss the following proposed indications for ABP 501:

  • Reducing signs and symptoms, inducing a major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active RA (alone or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs [DMARDs])
  • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older (alone or in combination with methotrexate)
  • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis (alone or in combination with nonbiologic DMARDs)
  • Reducing signs and symptoms in adult patients with active ankylosing spondylitis
  • Reducing signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy or who have lost their response to or are intolerant of infliximab
  • Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants, such as corticosteroids, azathioprine, or 6-mercaptopurine
  • Treating adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy when other systemic therapies are medically less appropriate

Adalimumab will lose its patent for the treatment of RA in December. After that, the drug is expected to face fierce competition from biosimilars and generics. Other patents for adalimumab are valid till 2020. 

Sources: Reuters; July 8, 2016; Forbes; July 6, 2016; and FDA; June 20, 2016.

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