Path to Action

The Action Plan offers strategies, tools, and activities needed to help achieve the Mission. The guidance is flexible which means that no matter where a country is on its biosimilars journey, you will be able to use the Action Plan to drive change.

To see information on the 30 target countries, visit the Act4Biosimilars Impact Index

Only by acting together and combining our efforts globally can we achieve the Mission to increase biosimilar adoption by at least 30 percentage points in 30+ countries by 2030. To join the movement, please download the Action Plan today! 

Act4Biosimilars Vision

How efficient is the regulatory approval process for quality-assured biosimilars? Rigorous regulatory pathways are vital to ensure only quality-assured biosimilars reach patients, but at the same time it is important that these pathways are optimized to take into account regulatory requirements that are necessary and appropriate. 

Assist the adoption of rigorous regulatory pathways for biosimilars in countries where these are currently lacking.Adoption of rigorous regulatory pathwaysKey initiative:Level Playing Field For Robust DossiersGoal:
Accelerate approval  anddevelopment  timelines for faster introduction of  biosimilars while maintaining robust standards.Optimize regulatory review proceduresKey initiative:Streamline biosimilars approvalGoal:

How open are healthcare stakeholders, such as healthcare professionals and patients, to prescribing or using biosimilars? As biosimilar use continues to grow worldwide, more healthcare professionals and patients are gaining and sharing real-world experience. Sharing these experiences can help to address the concerns of their peers, ensuring they understand that biosimilars match the safety, efficacy, and quality of their respective reference biologic.

Convince and supportgovernment organizations todevelop and endorse educational content on biosimilars andsupport their disseminationDrive publication of authoritative local educational contentKey initiative:Fair and accurate information - fighting disinformationGoal:
Activate local sharing ofbiosimilar treatment experience from other countriesInternational exchangeon biosimilar real-worldevidenceKey initiative:Share experience of biosimilars use across countriesGoal:
Incentivize patient education by HCPs (e.g., physicians, nurses, pharmacists) when startingpatients on biosimilars, including both naïve and transitioningpatients.“Switch On” patienteducationKey initiative:Involve patients in treatmentdecisionsGoal:

How easily accessible are biosimilars for patients? Multiple stakeholders affect the accessibility of a medicine, including the prescribing healthcare professionals and those who procure medicines, such as tender authorities and hospitals. Educating stakeholders, combatting misinformation, and encouraging peer-to-peer exchanges will increase awareness and confidence in biosimilars for all stakeholders.

Elevate trust in biosimilars via increased peer-to-peerexchanges among HCPsImprove peer-to-peerexchange betweenHCPsKey initiative:Create biosimilars marketsGoal:
Change disinformation-basedmisperception of non-medical switching by raising awarenessof the safety, efficacy andsocio-economic benefits ofswitchingForced Switching toInformed SwitchingKey initiative:Strong policies for switching tobiosimilarsGoal:
Educate relevant stakeholderson how to prescribe and access biosimilars in the local marketPromote effectivemedical guidelines Key initiative:Clear MedicalGuidelinesGoal:
Ensure local decision-makingstakeholders are aware ofavailability dates for newbiosimilars with upcoming patent expiry.Increase awareness ofbiosimilar availabilitydatesKey initiative:Respond to loss of market exclusivityGoal:

How cost-effective are biosimilars for governments and healthcare systems? A key aspect of affordability is encouraging sustainable competition between biosimilars and reference biologics – enabling payers (including: tender authorities, hospitals, insurers) to reduce their expenditure and increase access for patients. 

Identify and raise awareness of health system benefits resulting from biosimilar savingsKey initiative:Open dialoguebetweenproducers,tenderers &insurersGoal:
Instead of solely focusing onlowering price, offer support increating a sustainable pricingpolicy, in order to ensure rapidintroduction and long-termavailability of biosimilars frommultiple manufacturersIntroduce and widenadoption of sustainablebiosimilar pricing policiesKey initiative:Ensure equitablepricingGoal:
Increase local marketcompetitionKey initiative:Fair competition & swift market accessGoal: