Testing the barometer for biosimilars

With the London 2012 Olympics just behind us, we don’t need to be reminded that being first counts. So when Celltrion got approval for Remsima, its copy of Johnson & Johnson’s Remicade (infliximab) the South Korean company lost no time in proclaiming Remsima as the world’s first official biosimilar antibody to get approved. Remicade is considered a regulatory milestone in the biologics world, because it was one of the first monoclonal antibody (MAb) TNF inhibitors approved for the treatment of rheumatoid arthritis.

But is Remsima really the world’s first biosimilar MAb? Didn’t Dr Reddy’s Laboratory (DRL) get approval from the Indian authorities for Reditux way back in 2007, a full five years before Celltrion’s Remsima? As DRL’s brand of rituximab, a MAb used in the treatment of Non-Hodgkin’s Lymphoma, Reditux was launched in April 2007 in India and created quite a stir, both within the country as well as abroad.

It turns out that yes, Celltrion can claim that Remsima is the world’s first official biosimilar antibody, with the operative word being ‘official’. At the time Reditux was up for approval, the European Medical Agency (EMA) was the sole global regulator to have released guidelines for biosimilars, which it had released in 2005. In 2007, India, like most countries, did not have a separate approval process for biosimilars so Reditux was approved using an abbreviated version of the pathway for small molecule generics, with the regulatory bodies in India weighing the merits of each applicant on a case to case basis. Reditux was launched at half the price of the originator and it looks like the regulators in India decided that any affordable treatment was better than no treatment at all.

By the time Celltrion’s Remsima, came up for approval five years later, the Korean Food and Drug Administration had in place a biosimilar pathway based on globally accepted guidelines like the EMA and WHO. Thus Celltrion can claim that Remsima is the world’s first official biosimilar Mab.

Come September, India’s biosimilar guidelines will be in place and this time, they too are modelled on global norms. But this is just a first step, as our cover story, ‘Gearing up for the biosimilar boom’, points out. Across borders and jurisdictions, global regulators are not satisfied with their own regulations for biosimilars and are constantly debating further changes to keep pace with technology and clinical evidence. At best, everyone (somewhat) agrees that the WHO definition of biosimilars is on track. But that is possibly the only point of consensus.

While the current philosophy might be to focus on proving similarity, the question being debated is to what degree must the biosimilar be similar to the originator? And how much clinical trial data is required to judge safety and efficacy of the biosimilar? How much should the guidelines control the manufacturing process itself since even small, seemingly insignificant variations in the manufacturing or storage process could impact clinical results?

Originators are naturally pushing for high benchmarks to scare off competition, but governments and regulators are aware that biosimilars are key to keep healthcare costs down. Estimates are that seven of the top 10 drugs prescribed in the US, the world’s biggest market for biosimilars, will be biologics and while this spells opportunity for biosimilar manufacturers, it also means that regulators will have to be sure that they have a fool proof system in place to test biosimilars. The regulators in India were right to postpone the implementation date by a month in order to get feedback from the industry. Before we ride the biosimilars boom, regulators the world over will have to ensure that the guidelines governing biosimilars go a step further than the Olympic motto: “Faster, Higher, Stronger” adding SAFER to this credo.

Viveka Roychowdhury
Editor

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