In the future, new analytical methods will facilitate the development and regulatory approval of biosimilars.
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They will have to promote biosimilars to doctors, as they do for brand-name drugs.
"There are so many unknowns commercially, " said Scott Foraker, who heads Amgen's year-old biosimilars unit.
Concurrently, over the past few years the broader view of the biosimilars market has changed.
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"The essence is not going to be a typical generics business, " said Michael Kamarck, who's heading Merck's biosimilars effort.
Therefore, development costs will be higher and there will be far fewer biosimilars developed than generic versions of small molecule drugs.
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That means new competition can enter the market there more easily, including competition from biosimilars--the equivalent of generics for biotechnology drugs.
But for now, the new regulatory pathway for most biosimilars will not be significantly abbreviated or greatly affect burgeoning health care costs.
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If we really knew how drug target selective compounds and even biosimilars (inter-)act, we should be able to predict side effects much better.
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Therefore, as the name implies, all new generic biological drugs, also called "biosimilars" or "follow-on biologics, " will be similar--but not identical--to the original drugs.
In addition to renewing the prescription drug user fees, the FDA is seeking to create two new user fees for generic drugs and more complex biosimilars.
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Consequently, they have expressed their intention to submit a new Biologics License Application (BLA) to obtain marketing approval, rather than an abbreviated submission via the biosimilars pathway.
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Second, biologics are really difficult to copy, and thus even after the patents expire, knock-off biologics (biosimilars) are far less a threat than knock-off small molecules (generics).
He said the brief history of biosimilars in Europe, where the medicines are approved, showed the need for "actively promoting" the medicines in order to get them used.
Gal argues, however, that the presence of credible players will accelerate the adoption of biosimilars and could drive more rapid price declines in markets with effective payer schemes.
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Eventually, the availability of biosimilars will spur competition and reduce prices somewhat, and because of advances in technology, some of the follow-on products may even be superior to the original brand-name biologicals.
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The reason to think Merck may succeed, argues Tim Anderson of Sanford Bernstein, a research firm, is that it has found a way to make biosimilars by culturing them inside yeast cells.
At the same time that Amgen is getting ready to launch its own biosimilars, Amgen and other biotechs are campaigning state governments to make it harder to substitute a biogeneric for a brand.
The real question is to what extent branded companies such as Amgen which are also developing biosimilars want to limit the future role of these products or simply raise the barriers to entry.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
This will put Merck in direct competition both with generics firms, such as Teva of Israel, and with biotech giants, such as Amgen, which make the expensive products that biosimilars hope to replace.
Manufacturers will have to get doctors to overcome their comfort and experience with using branded biologics and persuade them to prescribe something comparable, said Gillian Woollett, a biosimilars expert at consulting firm Avalere Health.
The FDA has yet to pass judgement on the subject of substitutable or interchangeable biosimilars, but consensus indicates that such a status could be conferred on a biosimilar if it is supported with more extensive clinical testing.
FORBES: Gamekeeper or Poacher? - Big Pharma's Stance on Biosimilars
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