Wednesday, December 31, 2008

AstraZeneca considers pursuing "biosimilars."

From ""

AstraZeneca is considering joining several of its peers in pursuing "biosimilars" -- generic versions of high-priced biotechnology drugs.

The London-based drug maker has made a push into the $94 billion market for biologics in recent years with the acquisition of Cambridge Antibody Technologies in 2006 and last year's $15.6 billion purchase of Maryland-based MedImmune.
Generic versions of biologics -- drugs made from living cells rather than chemicals -- are not yet approved for sale in the United States.
The complexity of dealing with the larger biological molecules makes it impossible to create an exact copy of a biologic drug, prompting concerns that the biosimilar medicine may end up working differently than the original drug.
But amid the growing popularity and high price tags of many biologics, Congress is expected to consider a regulatory pathway next year to bring biosimilars to market. President-elect Barack Obama has said he supports biosimilars.
Several large drug makers, threatened by patent expirations on top-selling products, are looking at biosimilars as a potential source of revenue. Merck said earlier this month it would start a new unit to copy biologics, and Eli Lilly has also expressed interest in the market.
In an interview published last week by the Financial Times, AstraZeneca CEO David Brennan said the company was studying the launch of biosimilar products, although he said such a move would depend on the legislation being considered by Congress.
AstraZeneca, whose U.S. headquarters is in Fairfax, said in a statement that MedImmune has facilities well-equipped to produce biosimilars, "should we choose to do so and if the legal and regulatory framework allowed.
"However, at the current time, we see the strongest opportunities for the business in flexing its track record of innovation, developing its pipeline of potential biologic candidates to treat or prevent a number of debilitating or life-threatening diseases," the company said.
U.S. and European regulators have a streamlined approval process for generic versions of conventional small-molecule drugs, which are easier to copy than biologics. The European Union has an approval procedure for certain biologics.
Novartis AG's generic-drug unit two years ago became the first company to have a biosimilar product approved: the growth hormone Omnitrope.
The European Commission last August cleared Novartis' anemia drug that is similar to Johnson & Johnson's Eprex and Amgen's Epogen.

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