Amgen, Inc. (NASDAQ:AMGN)’s Adalimumab Biosimilar Drug, ABP 501 Gets Nod From EU

Amgen Inc

The Committee for Medicinal Products for Human Use (CHMP) of the EMA or European Medicines Agency recently gave its nod to Amgen, Inc. (NASDAQ:AMGN) for the ABP 501 drug (a doppelganger for adalimumab). Amgen, in its recent press release, announced that CHMP gave a positive response to ABP 501 when it comes to market authorization. The EMA gave a positive opinion for the available indications of the drug.

ABP 501 approved for certain inflammatory diseases

The CHMP opines that ABP 501 is approved for treating a few inflammatory diseases among adults, which also include psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis (AS), chronic plaque psoriasis and a few more diseases/ conditions.

In fact, the body has also given its opinion over recommending the treatment for a few pediatric inflammatory diseases. According to the CHMP opinion, ABP 501 drug is also a viable option for treatment of a few pediatric inflammatory diseases, which include polyarticular juvenile idiopathic arthritis, severe chronic plaque psoriasis and Crohn’s disease.

The first of its kind approval of an adalimumab biosimilar in EU

Amgen’s executive vice president at R&D department, Sean E. Harper said, “The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU.”

Amgen has been working on the biosimilar portfolio, of late. The company believes that this approval will prove to be a “significant milestone” for its biosimilar product line. Mr. Sean E. Harper believes that this is a vital response so as to develop “high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”

The CHMP opinion goes to European Commission for review

The next step involves sending the positive response of CHMP to European Commission (EC) for review. EC is the authority meant for approving medicines and drugs for the commercialization purpose in the European Union.

If Amgen’s ABP 501 drug gets a nod from the European Commission as well, it would mean commercialization of drug in 28 countries in the EU. Apart from this, the members of European Economic Area (EEA) (which include Norway, Iceland and Liechtenstein), will take separate decisions on this, on the basis of EC’s decision.

ABP 501 has already been approved by the FDA, under the name AMJEVITA™.

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