For the first time, biosimilar versions of a monoclonal antibody (mAb) drug have been recommended for approval in the EU, opening a new chapter in the developing market for cheaper copies of biologic medicines.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions on biosimilar versions of Johnson & Johnson’s arthritis and Crohn’s disease treatment Remicade (infliximab) filed by Celltrion Healthcare and Hospira. The reference product posted European sales of over $2bn last year.
A subsidiary of South Korea’s Celltrion is seeking to market its biosimilar version of the mAb as Remsima, while the brand name for Hospira’s version is Inflectra. Celltrion has already launched Remsima in South Korea and has filed the product in a number of other markets around the world.
Hospira’s product stems from a wide-ranging collaboration it signed with Celltrion in 2009 to develop eight mAb biosimilars, and has rights to sell Inflectra in Europe, North America and Australia/New Zealand.
The EMA said in a statement that this is “the first time that the biosimilar concept has been successfully applied to such a complex molecule” and comes after it published a specific guideline for biosimilar mAbs last year.
To date a total of 12 medicines have been approved under the biosimilar regulatory pathway first laid out by the EMA in 2006, covering a range relatively small protein-based drugs including epoetins, filgrastims, growth hormones and recombinant human interferon alfa-2a.
The increased size and complexity of mAbs makes it more challenging for sponsors to be able to demonstrate that their biosimilars do not have any meaningful differences from the reference medicine in terms of quality, safety or efficacy.
The opportunity is however huge. The mAb sector – valued at around $78bn in 2012 and expected to reach $42bn in Europe alone by 2018 – represents a lucrative new market for biosimilar competitors, given that almost two-thirds of the market last year was made up of drugs that are already approaching or beyond patent expiration.
Meanwhile, lower-cost versions of first-generation mAbs will take pressure off cash-strapped healthcare systems across Europe.
“We believe that the first biosimilar mAb approval by the EMA will spearhead the start of a new era of biosimilar mAbs in the pharmaceutical industry,” said Celltrion in a statement.
The EMA – which has published a series of guidance documents in a bid to hasten the development of the biosimilar market in recent months – is expected to deliver its final verdict on the applications for Remsima and Inflectra within three months.