Role of Biosimilars in the Treatment of Rheumatic Diseases
Role of Biosimilars in the Treatment of Rheumatic Diseases
A biosimilar is 'a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product', with similarity defined as 'the absence of a relevant difference in the parameter of interest'. Biosimilars should be developed strictly in accordance with comparative procedures used for reference products, as mandated by regulatory authorities, such as the European Medicines Agency (EMA) or US Food and Drug Administration (FDA). These stringent processes ensure that no clinically meaningful differences exist between the biosimilar and the reference product in terms of 'safety, purity and potency' (FDA), or 'quality, safety and efficacy' (EMA).
Currently, several products labelled as 'biosimilars' are approved for treatment of rheumatoid arthritis (RA) in a number of countries that, at the time of approval, did not have stringent regulatory processes in place to ensure comparability as defined by EMA and FDA (Table 2). While these products apparently meet local regulatory requirements, they should not be considered biosimilars, but rather, 'intended copies'. Physicians must be aware of the distinction between these and 'true' biosimilars that meet EMA/FDA standards, as well as the differences between biosimilars and other 'biological copies' (Table 3).
Currently, there are no biosimilar mAbs or Cepts approved by EMA or FDA for treatment of rheumatic diseases, although randomised controlled trials (RCTs) are complete or on-going (Table 4). Earlier in 2012, the South Korean company, Celltrion, filed for EMA approval of a biosimilar infliximab product, CT-P13. Two large RCTs—one in 600 RA patients and another in 250 patients with ankylosing spondylitis (AS)—indicate that the efficacy, safety and immunogenicity of CT-P13 are highly similar to infliximab. This biosimilar has recently been approved by the Korean authorities for several indications, including RA and AS.
Defining Biosimilar
A biosimilar is 'a biotherapeutic product which is similar in terms of quality, safety and efficacy to an already licensed reference biotherapeutic product', with similarity defined as 'the absence of a relevant difference in the parameter of interest'. Biosimilars should be developed strictly in accordance with comparative procedures used for reference products, as mandated by regulatory authorities, such as the European Medicines Agency (EMA) or US Food and Drug Administration (FDA). These stringent processes ensure that no clinically meaningful differences exist between the biosimilar and the reference product in terms of 'safety, purity and potency' (FDA), or 'quality, safety and efficacy' (EMA).
Currently, several products labelled as 'biosimilars' are approved for treatment of rheumatoid arthritis (RA) in a number of countries that, at the time of approval, did not have stringent regulatory processes in place to ensure comparability as defined by EMA and FDA (Table 2). While these products apparently meet local regulatory requirements, they should not be considered biosimilars, but rather, 'intended copies'. Physicians must be aware of the distinction between these and 'true' biosimilars that meet EMA/FDA standards, as well as the differences between biosimilars and other 'biological copies' (Table 3).
Currently, there are no biosimilar mAbs or Cepts approved by EMA or FDA for treatment of rheumatic diseases, although randomised controlled trials (RCTs) are complete or on-going (Table 4). Earlier in 2012, the South Korean company, Celltrion, filed for EMA approval of a biosimilar infliximab product, CT-P13. Two large RCTs—one in 600 RA patients and another in 250 patients with ankylosing spondylitis (AS)—indicate that the efficacy, safety and immunogenicity of CT-P13 are highly similar to infliximab. This biosimilar has recently been approved by the Korean authorities for several indications, including RA and AS.
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