Concerns beyond FDA Approval for Biosimilars

In a recent article at the Association of Corporate Council, they look at a few of the facts beyond the FDA's jurisdiction for decisions.

Their key aspects:
-the availability of biosimilars will put pressure on biologic drug manufacturers
-which have not had to grapple with the same limited marketing exclusivity periods
-patent cliffs for biologics that small molecule drugs have been subject to for two decades.

What do you think about these three issues? While the FDA has the key to bring biologics to market, what about the limited marketing exclusivity periods? Are these the things you are most concerned about? What other concerns does your company face with biologics?

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How will healthcare reform affect Pharma?

Kaiser Health News recently wrote an article detailing the new healthcare bill and how it will affect those involved including Pharma, hospitals, insurers and doctors.

Even though the industry will face $84.8 billion in new taxes, they will receive:

-- The drug industry will put up $84.8 billion to help fund the legislation. Part of that goes to making brand-name drugs more affordable for seniors who hit the Medicare coverage gap - the "doughnut hole." But pharmaceutical firms stand to make much more in return. With more Americans insured, more can buy brand-name drugs.

-- Expensive biologic drugs would get 12 years of exclusivity protection from generics. Obama, AARP and the generic drug industry were calling for a 5- or 7-year limit. While biologic drugs are only a small portion of industry sales, they represent the fastest-growing segment of the market.

-- The legislation, despite the pleas of some lawmakers, doesn't make it easier for Americans to buy less expensive drugs from abroad. Nor does it allow the government to negotiate lower drug prices for Medicare.


To find out more about the effect this healthcare bill will have on biosimilars at IIR’s Generic Drug Summit: Business of Biosimilars. In 2009, the event was expanded to deliver brand and generic companies innovative tools to compete in the business of biosimilars and biogenerics. The event is well positioned to become the leading business meeting for executives looking to profit in the emerging market of biosimilars and biogenerics. Visit the webpage here.

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