EFPIA Calls for Regulatory Reforms to Encourage Development of Biosimilars
With a growing number of biologics set to lose patent protection in coming years, a leading industry group is calling for regulatory reforms to encourage the development and approval of biosimilars.
The plan — released last week by the European Federation of Pharmaceutical Industries and Associations — calls for regulatory incentives for biosimilars development, quick market entry when a novel biologic loses exclusivity and mechanisms to ensure that cost-savings from increased competition are passed on to patients and payers.
EFPIA also recommends more transparency around pricing. List prices for biosimilars should be publicly available, as well as information on clinical differences between biosimilars and their reference product and the savings realized from competition.
To ensure traceability, adverse event reports for all biologicals should include the brand name, active substance and batch number. This will allow case reports to be used for signal detection and data quality analyses, the group says.
Doctors should also be required to prescribe by product name, rather than international nonproprietary name, so that records can identify which product caused an adverse event. An INN alone is not sufficient to identify a biological medicine, and prescribing with INNs only could lead to unintended switching of a patient’s treatment and undermine the traceability of the medicine dispensed, EFPIA says.
The EU has had a legal framework for approving biosimilars since 2004. As of February, the European Medicines Agency had approved 21 biosimilar products, according to the Belgium-based Generics and Biosimilars Initiative.
Read EFPIA Policy Principles for Off-patent Biologic Medicines in Europe here: www.fdanews.com/9-15-EFPIA-PositionPaper.pdf. — Jonathon Shacat