EU committee backs approval of first Remicade biosimilars from Celltrion, Hospira

The European Medicines Agency’s Committee for Medicinal Products for Human Use on Friday backed approval of the first biosimilar versions of Johnson & Johnson's Remicade (infliximab) from Celltrion and Hospira. The agency noted that the decision marks the first recommendation for monoclonal antibody biosimilars, adding that since the clearance of the first biosimilar in 2006, there are now 12 approved biosimilar medicines in Europe.

According to the EMA, both Remsima and Inflectra have been shown to be similar to Remicade and are recommended for authorisation in the same indications as Johnson & Johnson's therapy, covering autoimmune diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. "This is a landmark occasion," remarked Bloomberg Industries analyst Asthika Goonewardene.

Hospira noted that in a Phase III trial, Inflectra met its main goal of therapeutic equivalence to Remicade. Results showed that 73.4 percent of patients receiving Inflectra achieved a greater than 20 percent improvement in rheumatoid arthritis symptoms after 30 weeks of treatment, compared with 69.7 percent of patients treated with Remicade. The company added that the safety and tolerability of Inflectra was also comparable to Remicade. Hospira, which indicated that sales of Remicade reached more than $2 billion in Europe last year, entered an agreement with Celltrion in 2009. Under the deal, Hospira gained the rights to Inflectra in Europe, the US, Canada, Australia and New Zealand.

Celltrion CEO Kim Hyoung Ki, suggested that "the price of Remsima will be more than 30 percent cheaper than those of the original drugs" in Europe. He added that "we’re confident in Remsima as it has price competitiveness, while it has the same effect as the original drugs." Company executive Kim Hyoung-ki added that the South Korean drugmaker plans to seek approval in Japan later this year, while an application in the US may be filed in 2015.

However, Barclays analyst Mark Purcell cautioned that Johnson & Johnson and partner Merck & Co. may initiate a patent infringement case against Celltrion and Hospira should they launch their products in Europe. The analyst noted that Johnson & Johnson has extended Remicade’s patent protection to February 2015 in the majority of EU markets, meaning Celltrion and Hospira will introduce their versions in a limited number of markets next year. Purcell estimated that the biosimilar could generate $560 million in sales in Europe. Remicade has US patent protection until September 2018.

Some analysts suggested the biosimilars may have difficulty penetrating the market, in part because of the need to sell the drugs to physicians who are skeptical of the new treatments. RBC Capital Markets analyst Shibani Malhotra said "Hospira will need to price at a discount to the brand and market the drug, lowering its profitability." Further, Johnson & Johnson and Merck "are also likely to counter-market against Hospira's biosimilar, and could potentially alter pricing" in response.

For further analysis on the biosimilars market, see ViewPoints: EMA opens door for biosimilar antibodies but physicians will need convincing and Biosimilar Defensive Plays -- Assessing the options.

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