The Wall Street Journal 
(2/10, B4, Burton, Rockoff, Subscription Publication) reports that the
Food and Drug Administration has established a shortcut to the US
market for "biosimilar" drugs that includes steps for companies to
follow. Rachel Sherman, FDA associate director for medical policy,
remarked that it is "an abbreviated pathway that will depend on existing
data." The Journal notes that drug makers such as Merck and Pfizer
have recently increased efforts to develop these
drugs.
(2/10, B4, Burton, Rockoff, Subscription Publication) reports that the
Food and Drug Administration has established a shortcut to the US
market for "biosimilar" drugs that includes steps for companies to
follow. Rachel Sherman, FDA associate director for medical policy,
remarked that it is "an abbreviated pathway that will depend on existing
data." The Journal notes that drug makers such as Merck and Pfizer
have recently increased efforts to develop these
drugs.
Bloomberg News
(2/10, Peterson) reports that the FDA "will require laboratory and
clinical studies to show that the generic versions, known as
biosimilars, are 'highly similar' to the originals." In a statement,
Janet Woodcock, director of FDA's Center for Drug Evaluation and
Research, remarked, "When it comes to getting new biosimilar products on
the market, FDA has taken an innovative approach to supporting their
development at every step of the process."
(2/10, Peterson) reports that the FDA "will require laboratory and
clinical studies to show that the generic versions, known as
biosimilars, are 'highly similar' to the originals." In a statement,
Janet Woodcock, director of FDA's Center for Drug Evaluation and
Research, remarked, "When it comes to getting new biosimilar products on
the market, FDA has taken an innovative approach to supporting their
development at every step of the process."
The Los Angeles Times
(2/10, Healy) reports in its "Booster Shots" blog, "The FDA's actions
Thursday promise US consumers the prospect of big savings and some
uncertainty too, as generic drug manufacturers and biotechnology firms
-- many of them outside of the United States -- begin to make and market
these complex medications."
(2/10, Healy) reports in its "Booster Shots" blog, "The FDA's actions
Thursday promise US consumers the prospect of big savings and some
uncertainty too, as generic drug manufacturers and biotechnology firms
-- many of them outside of the United States -- begin to make and market
these complex medications."
The Star-Ledger
(2/10, Todd) reports, "Michael Kamarck, who heads Merck's biosimilars
business, said the agency's guidelines are 'consistent with all the
signals the FDA has been offering drugmakers.'" He noted that while
"getting the drugs approved may be the first challenge," the company "is
already strategizing how it will market biosimilars so physicians and
patients accept them as being as safe and effective as the brand
biologics."
(2/10, Todd) reports, "Michael Kamarck, who heads Merck's biosimilars
business, said the agency's guidelines are 'consistent with all the
signals the FDA has been offering drugmakers.'" He noted that while
"getting the drugs approved may be the first challenge," the company "is
already strategizing how it will market biosimilars so physicians and
patients accept them as being as safe and effective as the brand
biologics."
CQ
(2/10, Adams, Subscription Publication) notes that "the public will
have an opportunity to comment on the draft guidances." The AP (2/10, Perrone), Reuters (2/10, Beasley) and MedPage Today (2/10, Frieden) also report this story.
(2/10, Adams, Subscription Publication) notes that "the public will
have an opportunity to comment on the draft guidances." The AP (2/10, Perrone), Reuters (2/10, Beasley) and MedPage Today (2/10, Frieden) also report this story.
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