Biosimilars in Oncology: Trastuzumab is taking off

Biosimilar launches of antineoplastic monoclonal antibodies represent a milestone in oncological care but also a new chapter in the application of biosimilars; introducing more prescribers, payers and stakeholders to the biological copies.

Rituximab biosimilars came to the European market in 2017, while trastuzumab biosimilars have been keenly awaited since, and were first launched in the UK in March 2018.  Since then we have seen different competitors enter markets across the EU to take on originator Herceptin.

Three trastuzumab biosimilars are currently authorised in Europe: Kanjinti (Amgen), Ontruzant (Samsung Bioepis) and Herzuma (Celltrion). The latest EMA CHMP recommendation for a fourth competitor to come to the EU market (Trazimera, Pfizer) is as recent as June. A long pipeline of copycat trastuzumab in development could be added here.1

Oncologists are ready for biosimilar use

Payers and prescribers are prepared to take advantage of the lower prices that trastuzumab biosimilars can offer and to make a dent in the >$2bn Herceptin revenues across Europe ($7.5bn worldwide, 2017 data).2 Within the oncology space, biosimilars are seen as a key source of savings to help finance innovative new treatments. Medical associations including the European Society of Medical Oncology (ESMO) and guideline groups in key markets such as Germany have already included biosimilars use in their latest recommendations within the oncology field.

Quick uptake is expected for trastuzumab biosimilars, taking advantage of cost savings

If we consider the five EU markets where trastuzumab biosimilars are available: Austria, Germany, The Netherland, Spain and the UK.3 GPI pulse data from June 2018 reveals biosimilar price levels 8% to 20% lower than Herceptin in terms of ex-factory price.3 This leaves aside the instances where price regulation sets the same price for originator & biosimilar, e.g. The Netherlands where international reference pricing (IRP) is applied: In this limited case here referencing trastuzumab in Germany and the UK – the graph below gives an idea as to how this method has created an “average” for the Dutch price level between the benchmark geographies based on trastuzumab prices there.

Biosimilar graph

Last year’s rituximab biosimilars introduction in Europe reveals biosimilar uptake that was considerably faster than what we have seen in the anti-TNF-alpha space in recent years. Rituximab biosimilars already take substantial market shares in major EU markets (>40% in terms of units).4,5

List price dynamics captured in GPI pulse pricing & reimbursement data show trends aligned with previous biosimilar launches: 10-20% discount vs originator across most EU markets, with higher price differentials in some of the Nordic and Eastern European markets.3

Biosimilar graph2.jpg

We anticipate nothing less in the trastuzumab space and expect to see a considerable boost in biosimilar use, possibly putting oncologists ahead of their colleagues when it comes to biosimilar prescribing. The GPI team is closely watching trastuzumab price development as we see new launches happening every month.

Complex discount and purchasing systems will drive net price and uptake

Country-specific discounting and procurement mechanism are further going to drive price erosion and uptake dynamics in the trastuzumab market, as well as national and local policies on substitution. Here we see the most varied approaches across EU and a complex web of local, national and cross-border price dynamics. Tools in different geographies include internal and external reference pricing, exclusive, as well as open tenders, mandatory discounts and uptake quotas.

Rituximab procurement policies are established across several EU markets and GPI’s consulting team are aware of several discount and purchasing agreements, such as open-house tenders with various sickness finds in Germany or the major hospital purchasing groups in France.

For trastuzumab contracting is expected to pick up in the second half of the year. The GPI team already noted that several sickness funds in Germany are pooling their purchasing weight in an announced tender covering well over 15 million insured lives, including big players such as the DAK and TK funds.

Strategic considerations for net price and volume optimisation are complex and need careful considerations of the competitive environment as well as country-specific policies.

See how GPI can support you, taking advantage of GPI pulse tracking of biosimilar competition, as well as our specialist consultant team’s knowledge of pricing and access dynamics across Europe.


  3. GPI pulse: