Biosimilars in the EU – Payers are key to driving uptake….
By Tijana Ignjatovic, Lead Analyst
6 September 2013
I am a Lead Analyst for market access and strategy at Datamonitor Healthcare. My team covers a diverse range of topics r...
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Research from Datamonitor Healthcare has revealed that the UK lags behind some European countries in terms of biosimilars uptake, and there is significant variation in the uptake of different product classes in all analyzed countries. As with generics, the degree of market uptake of biosimilars is closely linked with policies and incentives on the part of health authorities and payers.
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Biosimilars have to date had only a limited impact on the UK pharmaceutical market, with copies gaining just 30% of the volume market share of their reference product overall. This is despite the high volume of generic penetration within the UK market, which suggests a more challenging environment for biosimilars manufacturers. Uptake of biosimilars in the UK falls within the same bracket as some other EU nations, including France and Italy, but remains significantly behind Germany, which has around 50% volume uptake (Sheppard, 2013).
Factors hindering faster uptake include physician uncertainty about prescribing biosimilars and the lack of nationwide policies on the part of healthcare payers to boost use, especially in the retail setting. Pharmacist substitution of a biosimilar for an originator biologic is not allowed in the UK or anywhere in Europe, and in general biosimilars tend to be prescribed for newly diagnosed patients rather than switching patients from their existing treatment.
Nonetheless, biosimilar filgrastim (a recombinant human granulocyte colony-stimulating factor used to treat neutropenia) has exhibited a strong performance, reaching a 90% volume uptake in January 2013. The British Generic Manufacturers Association (BGMA) says that the availability of biosimilar versions of the drug has boosted the overall filgrastim market, with a 40% increase in overall daily volume usage of filgrastim since biosimilars were launched (Smith, 2013).
Safety, procurement, and prescribing
Reasons for the high uptake include low safety concerns associated with this product class, as well as adequate procurement and prescribing mechanisms that favor biosimilar use, which demonstrates that growth opportunities for biosimilars do exists in the UK when appropriate payer support is in place. For example, UK regional hospital tenders for filgrastim include all products in the class, and focus on several factors other than price. Furthermore, hospital protocols are changed so that the product that wins the tender is written into treatment protocols as the first-line treatment. As an awareness-raising measure, hospitals also publish information on the success of biosimilar uptake in achieving savings in their budgets (Walsh, 2013).
In contrast, biosimilar somatropin (recombinant human growth hormone) has fared significantly less well in terms of uptake in the UK. This is predominantly due to concerns about its suitability for children, the existence of several well-known branded products in various formulations and delivery devices, and the length of time it takes to see the benefit of growth hormone therapy. Other EU countries have also seen low uptake of biosimilar somatropin.
Uptake of epoetin (recombinant human erythropoietin) biosimilars has similarly been much lower than that of filgrastim in the UK, despite the drug also being used primarily in hospitals, with originator companies reported to have significantly dropped their prices. The UK’s comparatively low overall use of biologics relative to other key EU markets also remains a barrier to biosimilar market growth.
Likewise, in France, biosimilar filgrastim, which is purchased through hospital tenders, has achieved uptake of 73% of the filgrastim market. In contrast biosimilar epoetin has struggled due to safety concerns, recording an uptake rate of only 31% by volume in 2012 (Collet, 2013). Furthermore, physician reluctance to prescribe biosimilars, and the detailing necessary to convert them against a backdrop of antibiosimilars detailing by branded manufacturers, has acted as a key obstacle to biosimilars growth in the retail setting.
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