The World Health Organization (WHO) has issued a new plain language summary on country pharmaceutical pricing policies, as part of its efforts to promote the use of high-quality generic and biosimilar medicines.
WHO outlines policies and initiatives that could promote the use of quality generics and biosimilars in a new plain language summary of its Guideline on Country Pharmaceutical Pricing Policies (2015).
The document explains that multiple policies are necessary to achieve low prices and increase uptake of generics and biosimilars, and that promoting the use of these drugs improves access to lower‐priced equivalents of brand-name drugs.
It also explains that while promoting generics and biosimilars increases market competition and improves health equity, there is currently limited regulatory capacity to ensure the quality of generics and biosimilars, which can undermine public trust in them.
WHO makes several recommendations for policymakers responsible for promoting access to generics and biosimilars, including that countries:
• Enable early market entry of generics and biosimilars through administrative and legislative measures, e.g. encouraging early submission of regulatory applications and providing prompt review.
• Use multiple pricing policies to achieve low prices for generics and biosimilars, e.g. internal reference pricing, mark‐up regulation, tendering and lower patient co‐payments.
• Enforce a suite of policies to maximize uptake of generics and biosimilars, such as:
– legislation to allow generics (and, where appropriate, biosimilars) substitution by dispensers,
– legislation and incentives for prescribers to prescribe using International Nonproprietary Name instead of brand name,
– dispensing fees that encourage the use of generics and biosimilars,
– regressive mark-up where lower mark‐ups are applied for higher‐priced products and incentives are applied for dispensers,
– educational programmes on the quality and safety of generics and biosimilars for patients and healthcare professionals.
Examples of policies already implemented to promote the use of generics and biosimilars include removing regulatory barriers, using voluntary licence agreements, and implementing specific pricing policies (such as internal reference pricing). On the demand-side, policies include having lower patient co‐payments for generics, compulsory substitution of generics and biosimilars, and educational campaigns to raise awareness.
WHO highlights the fact that, while policies to promote generics have existed globally since the 1990s, most policies promoting the use of biosimilars are in higher-income countries in Europe.
In Italy for example, the medicines agency has recently published new guidelines for the pricing and reimbursement of medicines, including a streamlined process for generics and biosimilars . In Germany, biosimilars quotas have been used to influence uptake .
The role of authorized generics in improving access to medicines
Collaboration between regulatory authorities for biosimilars
Regulatory issues related to quality of biosimilars
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1. GaBI Online - Generics and Biosimilars Initiative. Italy publishes new guidelines on pricing and reimbursement of generics and biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/guidelines/Italy-publishes-new-guidelines-on-pricing-and-reimbursement-of-generics-and-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Influence of local policy measures and practices on biosimilar/originator market dynamics in Germany [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Sep 17]. Available from: www.gabionline.net/biosimilars/research/Influence-of-local-policy-measures-and-practices-on-biosimilar-originator-market-dynamics-in-Germany
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Source: World Health Organization