While small molecule drugs are ideal for generics replication, biological drugs are not so simple. Biological drugs are usually large, complex molecular structures derived from or produced through a living organism, making them very difficult to replicate.

The Amgen survey of 40 different payers found that payer perceptions of biosimilars include:
• Payers anticipate biosimilars will be a strategy to reduce specialty drug prices and most (88%) believe the category represents a compelling business opportunity
• Most (80%) do not expect biosimilars to emulate the generics market; instead, payers expect to consider them as lower-cost branded options
• While there are analogues from the European commercial experience, at this time, few US payers are relying on Europe’s experience for US forecasting

The survey also showed that although US payers are eager for biosimilars to reduce specialty drug prices, Europe’s experience shows the level of savings may vary. European experience suggests that the most important conditions for market uptake of biosimilars are driven by factors such as physician perception, patient acceptance, local pricing and reimbursement regulations and procurement policies and terms. Amgen’s research also indicates that the US path may share few characteristics with the global experience to date.

The main difference between the US and Europe when it comes to biosimilars are interchangeability and substitution at the pharmacy level. In Europe, the European Medicines Agency does not make any evaluation of interchangeability and individual Member States decide whether a biosimilar may be substituted at the pharmacy or not. In the US, the Food and Drug Administration (FDA) has the authority to make a decision on interchangeability. In addition, the Biologics Price Competition and Innovation (BPCI) Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without reference to the prescribing physician [1].

Related articles 
Price/access expected to be major drivers for biosimilars uptake

Payers in US getting ready for biosimilars

Payers in US expect biosimilars to reduce costs

Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA finally issues draft biosimilar guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 15]. Available from: www.gabionline.net/Guidelines/FDA-finally-issues-draft-biosimilar-guidance

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