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Amgen Files for Approval of Humira Biosimilar
Amgen has submitted an application to the FDA seeking approval to sell its first biosimilar product –– a less-expensive alternative to adalimumab (Humira, AbbVie), the world's top-selling prescription medication.
The new drug, ABP 501, has demonstrated clinical equivalence and comparable safety to adalimumab in late-stage clinical trials in subjects with rheumatoid arthritis and plaque psoriasis.
Data supporting switching patients from adalimumab to ABP 501 was included in the submission.
Several companies developing biosimilars are targeting adalimumab, which is still growing with annual sales approaching $13 billion. Amgen said it believes it is the first to seek approval of an adalimumab biosimilar with the FDA using a new approval pathway outlined by the agency.
Unlike generic versions of traditional chemical drugs, biotech medications are made from living cells and cannot be copied exactly –– thus the term biosimilar. Because they are more complicated to produce, biosimilars will not offer the huge discounts of standard generics, but they are still expected to generate billions of dollars in health care savings.
Earlier this year, the first biosimilar approved in the U.S. was a less-expensive version of Amgen’s infection-fighting white blood cell booster filgrastim (Neupogen), produced by Novartis.
Amgen is developing biosimilars of nine blockbuster medications, with plans to begin launches in 2017.
Source: Reuters, November 25, 2015