Hospira is all set to hit the market with Inflectra after the European Commission approved the US company’s biosimilar of Johnson & Johnson and Merck & Co's blockbuster Remicade

Inflectra (infliximab) is the first monoclonal antibody to be approved through the European Medicines Agency’s biosimilars regulatory pathway. The drug has been given the green light for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis psoriatic arthritis and psoriasis.

Paul Greenland, vice president of biologics at Hospira, told PharmaTimes that while the approval was a momentous occasion for the company, it also represents “a lighthouse event for the whole biosimilar industry”. Given the bumpy regulatory seas that biosimilar mAbs have had to navigate, he was especially pleased to see that the Commission was sufficiently impressed by the strength of non-clinical and clinical data presented by Hospira to approve all the indications that Remicade has been marketed for.

Striking among the data presented are those from a Phase III randomised, double-blind study where 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment compared with 69.7% treated with Remicade. Over 600 patients were involved in that trial, notes Mr Greenland, adding that the filing had also included data from a 250-patient study in AS.

As for launching Inflectra, Hospira licensed the drug (and seven other biosmilars) from South Korea’s Celltrion in 2009 for Europe and other markets, including the USA. Mr Greenland noted that for the territories in Europe where Remicade patents have expired, talks are ongoing regarding pricing and reimbursement and Hospira will launch its biosimilar once those discussions are completed.

As for the major European markets, Remicade patents run to the beginning of 2015 but Mr Greenland said Hospira will be ready to go at the earliest opportunity. In terms of pricing, he noted that the company has already launched biosimilars on the European market, including Retacrit (epoetin zeta) in 2008 and Nivestim (filgrastim) in 2010, and those drugs were priced at around 20%-25% less than the branded products.

Remicade recorded European sales of over $2 billion in 2012 and Hospira said that the introduction of biosimilar mAbs in Europe is expected to deliver savings of up to 20.4 billion euros by 2020, notably in France, Germany and the UK. However Mr Greenland told PharmaTimes that "the primary stakeholder is the physician” and Hospira is confident it can work with doctors and explain that while Inflectra is a more affordable option, it also offers similar quality, efficacy and safety to Remicade, as well as improving access.