European regulators publish draft guidelines for biosimilar antibodies

European regulators issued draft guidelines on the regulatory path for biosimilar antibody drugs, detailing the clinical trials needed, and also suggesting that different diseases could be addressed by the same antibody.
The European Medicines Agency said that "extrapolation of clinical efficacy and safety data to other indications of the reference mAb, not specifically studied during the clinical development of the biosimilar mAb, is possible based on the results of the overall evidence provided from the biosimilarity exercise and with adequate justification." However, the regulator noted that when a reference antibody was approved in two widely differing indications, such extrapolation for the biosimilar products would be more "challenging."
Clinical trials of biosimilar antibodies will be shorter than for non-generic drugs, although the EMA indicated that the drugs could be monitored more thoroughly than normal once they are approved. "As regards post-authorisation follow-up, the concept to be proposed by applicants may have to exceed routine pharmacovigilance, and may have to involve more standardized environments," the regulator said.
According to IMS Health, global sales of biologic drugs was $130 billion last year, while industry analysts estimate that the market for biosimilar products may be worth tens of billions of dollars in the second half of the decade. No generic monoclonal antibodies have been approved either in the US or EU, however, Sanford C. Bernstein & Co. analyst Aaron Gal expects copies of antibodies will reach those markets between 2014 and 2016. >
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Reference Articles
Novartis, Teva may get sales boost from new EU rules - (Bloomberg)
Draft guideline on biosimilar medicines containing monoclonal antibodies released for consultation - (EMA)
EU issues biosimilar antibody guidelines - (Forexpros)
EMA issues draft guidance on copying monoclonal antibodies - (NASDAQ)
**Published in "First Word"