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We believe investors should watch out for an approval of new drugs and label expansion of existing ones at Novartis as the company has been facing stiff generic competition for some of its key drugs like Diovan and Gleevec.

If immune responses to reference products are rare, then a premarket study powered to detect major differences in immune responses between products and a postmarket study designed to detect more subtle immunogenicity differences will suffice.

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Projections are likely to be most accurate for biosimilar epoetins, since these have been available in Europe for several years and therefore have known market trends.

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EU, where it was authorized December 2007 for anemia that is causing symptoms in patients with chronic renal failure; anemia in adults receiving chemotherapy to treat certain types of cancer and to reduce the need for blood transfusions; and to increase the amount of blood patients with moderate anemia can self-donate before surgery.

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Plans to manufacture a biosimilar bevacizumab were announced in 2012 by several manufacturers.

The data showing that, for example, an EU reference product and a US reference product are indistinguishable should obviate the need for a repetition of critical studies.

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PK profiles, especially bioavailability, for both the IV and SC route of administration suggests similar efficacy also for SC use.

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It took time for US consumers to accept generics despite the fact that they share a non-proprietary name with the reference product.

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The Committee concluded that it was reasonable for the Assessment Group to assume in the economic analysis that all erythropoiesis-stimulating agents (ESAs) offer the same effectiveness.

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By engaging today in advocating and implementing the highly similar standard for mAb biosimilars and working with EU on their published draft guidelines, the FDA can rejoin EMA in leading the oversight of all biologics for a global patient need.

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ABBV) filed a Citizen's Petition with FDA on Wednesday challenging the agency's decision to make biosimilar product labels mirror those of reference products.

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AET BioTech and BioXpress: Biosimilar being co-developed under agreement announced October 25, 2012; companies will be jointly responsible for development, registration, and manufacture of the biosimilar, based on BioXpress technology.

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Should patients or physicians be concerned that biosimilars are “similar” to originator drugs, not “identical”?

Samples from clinical studies should be evaluated in a blinded manner using a hierarchical testing scheme, following the recommendations applicable in the regulatory guidance for biopharmaceutical products.

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