Currently in Canada, switching and substitutability between originator biologics and biosimilars has not been established, however that is not the case internationally. Earlier this year the Dutch Medicines Evaluation Board (MEB) supported switching patients from an innovator biologic to a biosimilar, so long as health professionals are involved and the patient is informed of the switch. Furthermore, Norway is also currently conducting research on the safety and efficacy of patient switching in their Norswitch Study, and is also allowing physicians to make the decision regarding whether or not a patient can be switched either for medical or economic reasons.
Now Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) is following suit with a recent announcement recommending that biosimilars be suitable for substitution at the pharmacy level. These drugs would be ‘a’ flagged in the official Pharmaceutical Benefits Schedule, meaning that they would be eligible for substitution in cases where the data is supportive.
The data that will be considered to determine substitutability includes the following:
- Absence of data to suggest significant differences in clinical effectiveness or safety compared with the originator
- Availability of data to support switching between the originator and the biosimilar
- Whether the Therapeutic Goods Administration has deemed the product to be biosimilar with the originator
However, even if the biosimilar is ‘a’ flagged the patients will continue to have the final choice as to which version of the medicine they will receive.
This movement towards switching from originator biologics to biosimilars in several international markets indicates that other countries, including Canada, may follow suit. Inflectra™ (infliximab), a biosimilar of Remicade™, is currently navigating the Canadian reimbursement landscape and as of April 30, 2015 the negotiations between the pan-Canadian Pharmaceutical Allicance (pCPA) and Hospira Healthcare Corporation were still ongoing. The results of these negotiations may influence the uptake of switching between the innovator and the biosimilar moving forward.
To read more regarding stakeholder opinions on biosimilars and the possibility of switching being introduced in the Canadian market, please click here for a complimentary copy of PDCI’s International Trend Series issue Uptake of Biosimilars.
In 2012, PDCI released an executive report which outlines the market landscape for biosimilars in Canada and compares it with the environment in Europe and the United States entitled Subsequent Entry Biologics in Canada: Stakeholders Discuss the Regulatory, Pricing and Reimbursement Landscape. To order an electronic copy of this report please click here.
 Schofield, I. (April 14, 2014). Dutch take the lead on biosimilar switching – others to follow? SCRIP Intelligence. Retrieved from: http://www.scripintelligence.com/home/Dutch-take-the-lead-on-biosimilar-switching—others-to-follow-357882
 Schofield, I. (April 28, 2015). Norway’s infliximab experience shows effect of deep price cuts on biosimilar success. SCRIP Intelligence. Retrieved from: http://www.scripintelligence.com/home/Norways-infliximab-experience-shows-effect-of-deep-price-cuts-on-biosimilar-success-358091
 GaBi Online – Generics and Biosimilars Initiative. (June 19, 2015). Australia’s PBAC recommends substitution of biosimilars.
 Schofield, I. (June 22, 2015). Biosimilars are safe, Australian government tells the public. SCRIP Intelligence. Retrieved from: http://www.scripintelligence.com/policyregulation/Biosimilars-are-safe-Australian-government-tells-the-public-359060