The Norwegian Medicines Agency has announced plans to hold trials of its own to show the medical world that biosimilars are as effective as their brand name counterparts, and pose no extra risk, despite not being structurally identical.
Reuters reports that the trials will compare Hospira’s and Celltrion’s Inflectra, a monoclonal antibody theropy biosimilar to rival Johnson & Johnson’s Remicade. But despite Inflectra receiving approval to treat rheumatoid arthritis in a groundbreaking first move from the EMA in September, Remicade’s $2 billion sales remain relatively untouched.
The EU biosimilar market has been slow to take off. Far from the projected $45.5 billion in biologics savings by 2020, take up of biosimilars has been patchy across the EU and generally low. The majority of the EU has failed to follow in Germany’s footsteps and enforce a referential pricing system in tandem with quotas on biosimlar prescriptions. The result is that the cost savings associated with biosimilars are not being exploited by the majority of EU nations despite savage cuts to healthcare budgets across the continent.
Part of the problem is that doctors lack confidence in the biosimilars. And this is perhaps not surprising given the heated debate over the rules guiding the production and naming of biosimilars across the world. With no clear message about whether or not an approved biosimilar necessarily means that it is equivalent to it’s brand name counterpart, doctors are reluctant to prescribe biosimilar treatments.
But with increasing strain on healthcare budgets, and the FDA set to enter the biosimilar ring in the next year or so, there is some hint that biosimilars will begin to take up much more of the biologics space. And with biosimilars in development for a number of blockbusters, including Roche’s Herceptin, the future looks bright for biosimilars.