Global Regulators Caution Against Misinformation On Biosimilars
Executive Summary
A coalition of the heads of medicines agencies from around world tells health care professionals that they have confidence in biosimilars, and address attempts made to spread misinformation on these products.
The International Coalition of Medicines Regulatory Authorities has issued a statement for health care professionals in which it expresses its confidence in biosimilars and warns them about attempts by certain parties to misrepresent and undermine the quality, efficacy and safety of these products.
The coalition, which comprises the heads of 29 medicines agencies from around world, says the statement is designed “to confirm the confidence that global regulators have in biosimilar medicines, as these medicines are currently being introduced in more markets across the world and can provide significant benefits to patients, in terms of increased treatment alternatives, access and cost competitiveness.”
The ICMRA secretariat told the Pink Sheet that it has included a “clarification note” in the statement for health care professionals as in the past “there has been misrepresentation of the quality, efficacy and safety of biosimilars.”
Specifically, the statement urges health care professionals to be aware that as more biosimilars emerge onto the market, “advertising and other messaging from industry must respect the laws applicable in each country and should refrain from misrepresenting the quality, efficacy and safety of biosimilars that have undergone rigorous review by regulatory authorities.”
The ICMRA has also issued a similar statement aimed at patients. The secretariat explained that both statements underline the robust regulatory process and scientific rationale used to approve biosimilar medicines. Biosimilar pathways differ from the well-known regulatory process for the approval of other types of new medicines, and the scientific basis of the biosimilar pathway is not always well understood by health care professionals or patients, the secretariat said.
The ICMRA’s latest statements come follow the coalition’s announcement last month that the European Medicines Agency’s executive director Guido Rasi – a proponent of biosimilar medicines - will be its new chair from 1 October. (Also see "EMA's Rasi To Head Global Coalition Of Drug Regulators" - Pink Sheet, 10 Jul, 2019.)
In the EU, the use of biosimilars varies widely by molecule and by country, and often within the same country, depending on factors such as doctor incentives, purchasing and reimbursement policies, and the perceptions of health care professionals and patients that are often swayed by misinformation on the safety of biosimilars. (Also see "EU Countries Examine Reasons For Wide Differences In Biosimilar Usage" - Pink Sheet, 1 Apr, 2019.)