The American College of Rheumatology (ACR) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability, substitution, naming and post-marketing surveillance of biosimilars.
The ACR position statement lists eight cautionary points that the association believes should act as guiding principles when it comes to approving biosimilars:
- The size, complexity, and heterogeneity of biologicals (and thus biosimilars) necessitate a greater degree of scrutiny in their analytical evaluation than what is typically required for small molecule generics.
- Clinical trials in humans are necessary to ensure the safety and efficacy of biosimilars, and provide the necessary level of confidence for their use by patients and providers.
- The decision to substitute a biosimilar should only be made by the prescriber. In jurisdictions where substitution by someone other than the prescriber is lawful and prior notification is not possible, the prescriber and the patient should be notified immediately when a substitution is made.
- Prescribers must retain the right to write ‘dispense as written’ for all prescriptions.
- The ACR objects to compulsory switching of stable patients to a different medication (including a biosimilar) of the same class for cost saving reasons without advance consent from the prescribing provider.
- Biosimilars must have distinct names allowing them to be distinguished from each other and their reference products. This is essential for ongoing pharmacovigilance.
- Long-term post-marketing registry-based data collection for each individual biosimilar is necessary to monitor for less common but nevertheless important adverse events.
- Post-marketing surveillance studies are needed in children as well as adults, as toxicities and long-term sequelae may be different. The Best Pharmaceuticals for Children Act 25 (BPCA), which reauthorizes the paediatric studies provision of the FDA Modernization and Accountability Act to improve safety and efficacy of pharmaceuticals for children, should apply to biosimilars.
The new position statement from ACR did not mention extrapolation of indications. In their previous position statement on biosimilars ACR had advocated for clinical trials in each indication .
The ACR does, however, tackle the contentious issue of substitution by pharmacists, which it believes should not be allowed, saying that any decision to substitute should be made by the prescriber. US states have in recent months been passing legislation that allows for substitution of biosimilars at the pharmacy level without prior notification . Most of these laws have also been using the compromise language proposed by the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) . The compromise proposal requires the dispensing pharmacist to ‘communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer’ ‘within a reasonable time’. The proposal also allows for the information on substitution to be provided via an interoperable electronic system.
Naming is also an issue that ACR has addressed in its position statement, not surprisingly, given their previous stance on biosimilars, advocating for distinct names for biosimilars. They state that this is ‘essential for ongoing pharmacovigilance’. The ACR also sent a letter to Food and Drug Administration (FDA) on this issue in December 2014, which stated that ‘biosimilars are not equivalent’ and that ‘shared names can cause confusion among physicians’. They added that ‘distinguishable names allow for transparency in notification and substitution’ and that ‘distinguishable names will strengthen adverse event tracking and post-marketing surveillance’.
Same names have not been found to cause confusion in Europe, where biosimilars have been in use since 2006 and where both the brand name and International Nonproprietary Name (INN) are used to identify the specific biological product, whether it is an originator product or a biosimilar. In fact, EU Member States have said that they strongly support that biosimilars should be closely aligned with their reference product and that it is not problematic to identify the biological products, which are subject to adverse reaction reports .
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