Loss of Exclusivity: Generics Hit Fast, Biologics Hold Strong

After loss of exclusivity, small-molecule generics bite quick and hard, while biologics remain resilient

A glimpse at patient flows on and off of JANUVIA® in France shows just how rapidly generic uptake can overtake a branded drug after loss of exclusivity.

Fig. 1: Patient flows for Januvia versus generic sitagliptine, post-LOE, in France

Source: Clarivate Patient Data Intelligence

Merck/MSD’s DPP-IV inhibitor JANUVIA (sitagliptin) lost exclusivity for type 2 diabetes in Europe at the end of 2021. Community pharmacy data for France show JANUVIA patient counts declining from 290,300 in August, 2022 to 75,000 a year later, seeing an average of nearly 30% of patients switching to sitagliptin each month for that period. Over the same time span, patients receiving generic sitagliptin went from none to 299,500 . Meanwhile, patient counts for JANUMET ® (sitagliptin and metformin HCI), which lost exclusivity several months later, fell from 450,200 in March, 2023 to 173,700 by August, 2023, while patients using generic sitagliptin metformin rose to 260,700.

Patient data for HUMIRA® tell a strikingly different story. The AbbVie biologic lost exclusivity in Europe in 2018, but has held onto a dominant market share despite entry of multiple biosimilar competitors. By August, 2022, community pharmacy data for France show HUMIRA with 63,600 patients to a field of eight biosimilars covering 48,700 patients co mbined. In August, 2023, HUMIRA patient counts had fallen just 13% to 55,300 in France while all adalimumab biosimilars combined accounted for 63,800. Over that 12-month period, HUMIRA saw just 1.3% of patients switch per month, on average.

Fig. 2: Patient flows for Humira versus generic competitors in France post-LOE

Source: Clarivate Patient Data Intelligence

“What we’re seeing here is the resilience of complex blockbuster biologics,” said Nicole Parisi, Clarivate Lead Business Analyst. “These data show that HUMIRA is only being marginally affected, even as all of its biosimilar competitors are growing.”

The continued strength of HUMIRA in France is particularly remarkable, Parisi noted, given that biosimilars are better entrenched in Europe, where a biosimilar was first approved in 2006. In the U.S., biosimilars have only been on the market since 2015 and have seen a rockier path to adoption, facing barriers to market entry like pharmacy benefit managers (PBMs), which have been accused of throttling access in exchange for rebates from the manufacturers of blockbuster biologics.

However, in Europe as in the U.S., physicians tend to favor the tried-and true.

“Clinicians are loathe to switch their patients from something that’s working to an unknown,” said Parisi.

The data also provide some evidence for the argument that biosimilars increase access to expensive biologic treatments, as the overall number of prescriptions for HUMIRA and all biosimilar competitors increased 6% for the period in France.

Clarivate’s ex-U.S. real-world data powers near-real time intelligence across countries in Europe, Latin America, Asia Pacific, and Africa. Clarivate Patient Data Intelligence (CPDI) is an online interactive platform that leverages data from E.U. 5 markets (Germany, France, Spain, Italy and the U.K.) to track patient flows on and off of treatments in order to help companies understand loss of exclusivity impact as well as treatment pathways, adherence and persistence, co-prescriptions and patient demographics.

Learn more about the CPDI tool and view sample data here.