BioSim Welcomes The Reception Of Its Main Proposals In The New Medicines Act, But Expresses Caution Regarding The Practical Application Of Dynamic Pricing

• The Association welcomes the inclusion of mandatory prescription by brand name for biologics, the express elimination of biosimilars as substitutable in the legal text and the exemption from the deductions of Royal Decree-Law 8/2010.
• However, the employers' association warns of possible inconsistencies in the new Dynamic Pricing System, which seems to be based more on competition in the market of homogeneous groups than on the effective promotion of the biosimilar medicines quota.

The Spanish Association of Biosimilar Medicines (BioSim) expresses its satisfaction following the publication of the final text of the Draft Law on Medicines and Medical Devices. This is a long-awaited and far-reaching legislative update for the healthcare system, in which the Ministry of Health has made a significant effort to listen to and reconcile the demands of the various stakeholders in pharmaceutical services.

The final text reflects a high sensitivity to the claims presented by the biosimilars sector, consolidating a regulatory framework that provides greater legal certainty and recognizes the specificities of biosimilar biological medicines as a pillar of sustainability and access.

Key advances for the safety and certainty of biosimilars
At BioSim, we highly value the fact that the final text incorporates significant strategic advances for the sustainability of the National Health System (NHS) and the quality of patient care. The Law expressly states that the prescription of biological medicines, including biosimilars, will always be by their brand name, and also eliminates the explicit mention of biosimilars as automatically substituted medicines (“equally dispensable”). Furthermore, it addresses a long-standing request from healthcare professionals: that prescription support systems clearly identify the type of medicine (generic, hybrid, or biosimilar), as well as the most efficient options. The legislation also amends Royal Decree-Law 8/2010 (Final Provision Two), formally equating biosimilars with generics in the exceptions to mandatory deductions. Also included is a “historic” request from the Association: the creation of a Biosimilars Penetration Observatory, a monitoring tool that will allow for a transparent evaluation of the actual degree of implementation of these drugs at different levels of care.

Uncertainties regarding the Dynamic Pricing System
Despite the obvious step forward that it represents definitive elimination of selected pricing modelsBioSim expresses its reservations regarding the final configuration of the new Dynamic Pricing System.

The model proposed by the Ministry appears to apply to medicines included in homogeneous (and therefore substitutable) groups, and is also 'based on the effective degree of competition existing in the market and intended to promote further price reductions'. However, BioSim warns that having a competitive market does not guarantee an increase in the actual use of biosimilars.

If the dynamic pricing mechanism does not explicitly focus on increase the effective market penetration rate of biosimilar medicinesThe economic impact and the incentive for the entry of new alternatives will continue to be compromised.

Statement from the Directorate General of BioSim
'We are pleased because the final regulation reflects that the Government has listened to the biosimilar industry's arguments regarding brand-name prescription, transparency, and competitive parity, which provides essential reassurance for professionals and patients.'

'However, we still have some concerns about the implementation of dynamic pricing. If the goal is to generate efficiencies and ensure supply, the regulator must guarantee that this system directly incentivizes the use of biosimilars. We trust that during the parliamentary process we can clarify and refine these aspects, and, in this regard, we are available to all parliamentary groups from today onwards.'