Biosimilar Use Lags Globally, and OECD Says Marketing Rules Aren’t What Matters Most

Biosimilar uptake varies widely across countries, and the OECD finds no link between stricter promotion regulations and higher adoption. Instead, procurement, pricing policies, and prescriber incentives are the real drivers determining whether biosimilars succeed.

Biologic medicines are consuming an ever-larger share of national health budgets, and biosimilars have long been expected to relieve that pressure. Yet uptake remains uneven enough to concern policymakers. This OECD study, drawing on data and expertise from RIZIV-INAMI, AMGROS, France’s CNAM and ATIH, Germany’s WIdO, Italy’s AIFA, Korea’s MFDS, and IQVIA, asks a deceptively simple question: does stricter regulation of pharmaceutical promotion increase biosimilar use? Interviews with 29 experts across seven countries and a detailed multiyear dataset form the backbone of this rare empirical investigation.

The Promise of Biosimilars Meets Uneven Reality

Biologics are projected to reach 35% of global pharmaceutical spending by 2027, and biosimilars have already demonstrated their potential: price drops of 20–50% in Europe, expanded access in oncology and rheumatology, and, in some cases, an enlarged treatment pool as savings are reinvested. But the gains are highly inconsistent. Some countries exceed 30% biosimilar market share in key therapy areas, while others struggle to reach 10%. Uptake varies sharply by molecule, too. Hospital-administered oncology biosimilars such as bevacizumab and rituximab often reach near-total adoption, while trastuzumab climbs more slowly, and insulin glargine rarely escapes single-digit uptake. These discrepancies reflect clinical caution, inconsistent switching protocols, and entrenched brand loyalty, forces that pricing and reimbursement policies alone have not fully explained.

Promotion Moves Beyond the Traditional Playbook

Pharmaceutical promotion has evolved in ways that complicate regulatory oversight. While classical tactics, sales representative visits, samples, gifts, and conference sponsorships, are tightly regulated, newer forms of influence operate in the grey zone. Patient support programmes offer adherence tools, nursing follow-up, or administrative assistance tied to specific brands. Disease awareness campaigns shape public perceptions without naming products. Digital devices, injection pens, and apps create user loyalty embedded in treatment routines. Patient organisations and research communities often depend on industry sponsorship that is lightly regulated or entirely self-policed. Sunshine laws offer only a partial window: they track financial transfers to healthcare professionals, but not the broader ecosystem of value-added services, educational interventions, or digital brand extensions that increasingly define modern promotion.

A Patchwork of Regulations, but No Pattern in Uptake

The OECD mapped the regulatory landscape across Australia, Belgium, Denmark, France, Germany, Italy, and Korea. Germany, Italy, and France impose some of the strictest controls on promotional activities, while Australia and Korea rely more heavily on voluntary codes. Belgium and Denmark sit in the middle, with a mix of strict and lightly regulated areas. Yet when biosimilar uptake is plotted against regulatory stringency, no consistent pattern appears. Italy and Germany achieve high uptake under strict rules, but France, with similar restrictions, posts slower progress. Denmark, whose regulatory environment is relatively permissive, achieves some of the world’s highest biosimilar penetration. Australia and Korea show low uptake, but largely for reasons unrelated to promotional policy. Across specific promotional activities, such as patient support services, visits to clinicians, or sponsorship of medical meetings, the data remain scattered, showing no coherent link between regulatory tightness and actual biosimilar adoption.

Market Structure, Not Marketing Rules, Drives Adoption

The report concludes that market design, not marketing regulation, determines biosimilar uptake. Centralised procurement emerges as the most powerful driver: Denmark and Italy, where competitive tenders leave little discretion to prescribers or room for originator persuasion, see rapid and near-complete switching. Pricing rules can unintentionally suppress biosimilar use when originators match biosimilar prices, eliminating financial incentives to switch. Prescriber autonomy also plays a large role, where switching depends entirely on clinician initiative, uptake is slower, especially for self-administered biologics. Meanwhile, originator companies increasingly compete not through classical promotion but through delivery ecosystems: patented devices, digital apps, training services, and loyalty-reinforcing support programmes that biosimilars may lack. These commercial strategies fortify market share even in the presence of cheaper alternatives.

The OECD finds that regulating promotion, while important for ethical and transparency reasons, does not explain differences in biosimilar uptake across countries. Policymakers seeking to expand biosimilar use will make greater progress by reforming procurement, pricing, prescribing incentives, and switching protocols than by tightening advertising rules.