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Global PharmaPoint Ulcerative Colitis Drug Report and Event Driven Update Market Analysis to 2022
Another key event affecting the UC market is the anticipated launch of biosimilars, given that the patent expiry of the UC blockbusters, Remicade and Humira are set to expire in the US in 2018 and 2016, respectively.
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Overall, major barriers to the growth of the UC market include -
- Remicade and Humira losing patent protection in the mid-forecast
- Austerity measures favoring generic prescribing
- Biosimilars are predicted to face low uptake due to the lack of regulatory guidelines in some markets, such as the US
- The UC market has predominantly been driven by two TNF blockers, namely J&Js Remicade and AbbVies Humira. Although these TNF blockers have monopolized the UC market for almost a decade, the balance is about to be tipped, with Takedas Entyvio and J&Js Simponi launch in 2014, stealing market share from Humira and Remicade.
- Remicade and Humira will also be hit by their respective loss of patent protection in 2018 (US), 2015 (EU) and 2016 (US), 2018 (EU). Europe has already approved a biosimilar to Remicade, Celltrions Remsima, which will be marketed by Hospira under the brand name Inflectra in the EU. Due to lack of regulatory guidelines and the current debate about indication extrapolation for biosimilars based on a clinical trial in one indication, initial biosimilar uptake will be low, but by the end of the forecast period, in 2022 infliximab, adalimumab and golimumab biosimilars are forecast to become an established part of the UC market.
- Overview of UC, including epidemiology, etiology,...