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Regulatory Focus™ > News Articles > 6 > EMA’s CHMP Offers Positive Opinions for 4 More Biosimilars

EMA’s CHMP Offers Positive Opinions for 4 More Biosimilars

Posted 01 June 2018 | By Zachary Brennan 

EMA’s CHMP Offers Positive Opinions for 4 More Biosimilars

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval on Friday, including four biosimilars.

The biosimilars included three from Novartis’ Sandoz: Halimatoz, Hefiya and Hyrimoz, recommended for the treatment of certain inflammatory and autoimmune disorders, and all containing adalimumab. Sandoz said in a statement: “The CHMP opinion [fourth positive opinion in 18 months] recommends adalimumab for all indications matching that of the reference medicine: rheumatoid arthritis, plaque psoriasis, Crohn's disease and ulcerative colitis.”

Four other adalimumab biosimilars, including two from Amgen, one from Samsung Bioepis UK and one from Boehringer Ingelheim have already been authorized in the EU, and are expected to come to market this autumn. By contrast, in the US, two adalimumab biosimilars have been approved, though neither are likely to come to market before 2020.

A recent US legal settlement over adalimumab, known in the US as AbbVie's Humira, between Amgen and AbbVie, decided on 31 January 2023 for a launch date, while the EU will see competition 16 October 2018. The deal between the two companies means that AbbVie’s Humira, which was first approved by FDA in 2002 and has accumulated sales of more than $130 billion in its first 15 years on the market, will be on the US market for more than 20 years with no competition.

The average monthly spend per beneficiary in Medicare Part D in 2016 for Humira was $2,835, with an annual growth rate of 18%, according to CMS. In 2015, Medicare Part B and Part D spent more than $1.6 billion on Humira and the 2015 Medicaid total spend on Humira was $805 million.

CHMP also recommended Pfizer’s Trazimera (trastuzumab) for the treatment of breast and gastric cancer. This will be the fourth trastuzumab biosimilar to come to market in the EU. By contrast, Mylan’s Ogivri (trastuzumab-dkst) is the only trastuzumab biosimilar approved in the US and has yet to come to market.


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