EMA Committee Makes Decisions on Opioids, Follow-on Biologics

Nov 24, 2010

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued on Nov. 19, 2010, a summary of its latest meeting. Two key outcomes of the meeting include the agency’s procedure on modified-release oral opioids and its procedures for reviewing certain biosimilars.

With regard to opioid-based drugs, the committee finalized a re-examination procedure on modified-release oral opioid products for the management of pain at level III of the World Health Organization’s pain-management scale (i.e., the use of strong painkillers when other drugs have failed to control pain). Confirming its initial opinion [see background], CHMP recommended the suspension of formulations using polymethacrylate-triethylcitrate controlled-release systems. The reason, according to the summary, has to due with the products' interactions with alcohol. CHMP also recommended harmonizing current warnings on these products regarding their use in conjunction with alcohol.

On the topic of follow-on biologics, or biosimilars, CHMP adopted a draft guideline, Similar Biological Medicinal Products Containing Monoclonal Antibodies. This guideline describes nonclinical and clinical testing requirements for drugs that contain monoclonal antibodies that also claim to be similar to a drug already on the market. The guideline, to be published on the agency’s website, will be open to public comment for the next five months.

Finally, the committee adopted decisions on various applications from industry, such as those proposing extending treatment options for certain drugs already on the market in the European Union, and for restricting the use of modafinil-containing medicines. The full CHMP summary can be found on the EMA website.