Table of Contents
Biosimilars remain one of the pharmaceutical industry's hot topics. Branded biologics account for 7 of the 10 best selling drugs globally and significant legislative momentum was provided in 2013 when the European Medicines Agency (EMA) approved its first biosimilar antibody products (versions of the anti-TNF Remicade). There may be less regulatory momentum in the US market but further insight from the FDA – including its views on interchangeability – is expected to emerge over the next 12 months.
With approval of the first biosimilar antibodies, however, there has been a steady shift in focus from the development/regulatory space to the commercial landscape. Many questions are being asked; how will biosimilars compete on price?, what sales and marketing infrastructure will be necessary to support uptake? And, increasingly, are physicians ready for biosimilars and is the industry doing enough to educate who is arguably the key stakeholder in this market?
As physician familiarity with the biosimilar concept inevitably increases, this exposure will raise further pertinent questions for the practising community; interchangeability (i.e. with branded equivalents), the extent of clinical data available for biosimilars, indication extrapolation and naming conventions will all feature prominently as more products reach the market – see ViewPoints: Money for nothing? – Indication extrapolation remains key issue for biosimilar developers and Physician Views: At least some similarity needed in biosimilar naming conventions, say majority of physicians, but caveats remain
In a bid to address these questions and concerns, industry will play a pivotal role in supporting the education of physicians around biosimilars. In turn – among other considerations – it will have to pinpoint where and how best to promote the biosimilar message and in way that is designed to address the needs of patients and physicians, rather than those companies operating in this market segment.
Reasons to purchase this study
Our latest Physician Views poll asks 5 simple questions to oncologists and rheumatologists (the most likely users of biosimilar antibodies) based in the US and EU5:
- How familiar they are with the general concept of biosimilars
- Which issue is causing them the most uncertainty in relation to the current/future use of biosimilars in day-to-day clinical practice (indication extrapolation, substitution, clinical trial design, pro-biosimilar payer policies, naming conventions, patient awareness)
- Where they obtain the majority of their information and knowledge about biosimilars (conferences, printed media, online media, pharma companies, CME providers, other physicians)
- How they rate the quality of current biosimilar medical education programmes
- How they rate the neutrality of current biosimilar medical education programmes
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