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The EMA has established detailing requirements for regulatory approval for each of the categories of biosimilars currently approved, as well as for biosimilar products containing interferon alpha, interferon beta and low-molecular-weight heparins.

More realistically, adequate monitoring of patients treated with different product versions within a patient registry or observational cohort study, with access to a centralized laboratory able to apply standardized assays, could represent the most practical option for comparing longer-term outcomes associated with elective switching between the respective versions of the product.

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One of the limitations of this analysis is that the accuracy of the MIDAS data varied across the countries covered, particularly in relation to the hospital market; several products had a very high proportion of their sales on the hospital market, and there was a high likelihood of overstating prices and, consequently, expenditure estimates.

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The top six biologics already consume 43% of the drug budget for Medicare Part B, and if the current trend in increasing usage continues, expenditure will inevitably also increase.

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Effects of erythropoietin on strength and functional status of patients on hemodialysis.

Adjustments related to income from associated companies are recorded net of any related tax effect.

Table 1 Approved biosimilars in Europe Notes: Dashes in the table represents drug not approved.

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In this respect, in vitro evaluation of stimulation of CD86 expression on human dendritic cells was useful in moderating the potential risk associated with degradation products of polysorbate in a formulation of recombinant human erythropoietin.

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These agents have been tested in preclinical (animal) models and show varying degrees of erythropoiesis stimulation.

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In particular, management's expectations could be affected by, among other things: unexpected regulatory actions or delays or government regulation generally; the potential that the strategic benefits, synergies or opportunities expected from the strategic actions announced in January 2016, the creation and operation of NBS, or the transactions with GSK, Lilly and CSL may not be realized or may take longer to realize than expected; the inherent uncertainties involved in predicting shareholder returns or credit ratings; the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products which commenced in prior years and continues this year; unexpected safety, quality or manufacturing issues; global trends toward health care cost containment, including ongoing pricing pressures, in particular from increased publicity on pharmaceuticals pricing; uncertainties regarding actual or potential legal proceedings, including, among others, actual or potential product liability litigation, litigation and investigations regarding sales and marketing practices, government investigations and intellectual property disputes; general economic and industry conditions, including uncertainties regarding the effects of the persistently weak economic and financial environment in many countries; uncertainties regarding future global exchange rates, including the continued increases in value of the US dollar, our reporting currency, against a number of currencies; uncertainties regarding future demand for our products; uncertainties involved in the development of new healthcare products; uncertainties regarding potential significant breaches of data security or disruptions of our information technology systems; and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission.

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ASBM members and staff discussed biosimilars policy with attendees, including the need for the FDA to maintain high standards for safety and efficacy when approving biosimilars.

However, there are some biologicals for which immune responses have been linked to serious safety issues, notably the pure red-cell aplasia (PRCA) caused by cross-reacting neutralising antibodies against erythropoietin.

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They have the potential to change oncology costs by offering low-cost alternatives to existing expensive cancer drugs, but the patents and marketing exclusivities of oncology biologicals are expiring.

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