The human epidermal growth factor receptor type 2 (HER2)-positive breast cancer market is expected to face competition from the launch of biosimilars, according to a report by GlobalData.
Titled ‘Pharmapoint: HER2-Positive Breast Cancer – Global Drug Forecast and Market Analysis to 2025’, the report covers the HER-2-positive breast cancer market in the US, France, Germany, Italy, Spain, the UK, Japan and China.
Herceptin patents in the EU and Japan expired in 2014, paving the way for the biosimilar trastuzumab to enter the market.
Patents for the drug in the US, however, will not expire until 2019. Since the uptake of biosimilars is generally high in the European markets, the launch of trastuzumab biosimilars is expected to have a significant impact on the market landscape.
Application for the approval of the first biosimilar was filed in Japan in April, while several other trastuzumab biosimilars are currently under review with the EMA and the FDA, explains Maxime Bourgognon, PhD, PharmD, Senior Healthcare Analyst for GlobalData.
The launch of biosimilars is expected to be a significant challenge for Roche, which has a majority share in the market.
Although physicians are wary of supporting the clinical bioequivalence data of biosimilars, payers are expected to switch to the cheaper alternatives. The report predicts that the impact of trastuzumab biosimilars will be insignificant in markets where subcutaneous Herceptin is already being marketed at lower prices compared to the intravenous formulation.
Established markets where Herceptin use has reached saturation are expected to be the most affected by the launch of biosimilars, Bourgognon adds. In countries such as China, where patient access to Herceptin was limited due to high cost, the launch of trastuzumab is expected to promote increased adoption of the drug.