Aut idem substitution of recombinant finished medicinal products back on the agenda

Berlin. The Federal Joint Committee is making a new attempt to regulate the aut idem substitution of recombinant finished medicinal products in pharmacies. At its meeting on Wednesday (June 11), the self-governing body decided to initiate a consultation procedure on a corresponding amendment to the Pharmaceuticals Directive.

Pharmaceutical and pharmacy associations, medical societies, and other authorized parties can now submit expert comments until July 14. The draft amendment is intended to insert a new paragraph 40c into the Pharmaceuticals Directive, which provides "guidance on the interchangeability of biological reference medicinal products by pharmacies."

Planned for a long time

The substitution of recombinant finished products by pharmacists has been legally permitted since 2019, originally scheduled to start in August 2022. However, the regulatory mandate to the Federal Joint Committee (G-BA) was then postponed by a year. It was amended to state that "initially, guidance on the interchangeability of parenteral preparations of finished medicinal products for direct medical use by patients" should be provided. This was also done a year ago.

In the meantime, in autumn 2022, the European Medicines Agency (EMA) and the umbrella organization of national regulatory authorities, Heads of Medicines Agencies (HMA), confirmed in a joint statement that the biosimilars authorized throughout the Union since 2006 were "comparable in efficacy, safety and immunogenicity" and therefore interchangeable with their reference medicinal product or another equivalent biosimilar.

Pharma fears “extreme price pressure”

The industry's reaction to the G-BA's latest draft guidelines is hardly less harsh than the first time. In a joint statement by the pharmaceutical associations (vfa, BPI, Pharma Deutschland, probiosimilars, and BIO Deutschland), it is stated that by permitting aut idem substitution of off-patent biopharmaceuticals, health insurance companies would be given the opportunity to conclude exclusive discount agreements with manufacturers. This would result in "extreme price pressure on the affected companies."

A "short-term focus on the lowest price jeopardizes the care of seriously ill patients and simultaneously weakens Germany as a pharmaceutical and biotech location." The expected cost pressure will encourage "the relocation of production facilities to non-European countries." (cw)