One of these days, biosimilars will become available in the US. Of course, that depends on when Congress gets around to deciding on how these meds should be approved and regulated. Right now, there are three proposals floating around Congress, which are being fought over, primarily, by generic drugmakers, biotechs, insurers, large employers and consumer [...]

In a decision that shows how difficult it is to copy biologics, the FDA has rejected Genzyme’s request to sell a version of its Pompe disease drug, called Myozyme, which the drugmaker planned to manufacture at an additional site. But the agency ruled that any Myozyme made at the second plant should be considered a [...]

The behind-the-scenes machinations that will determine the blueprint for allowing generic biologics - or biosimilars, as many call them - is threatening to emerge as a consumer healthcare issue. Or that’s what is hoped by a group of generic drugmakers, insurers, pharmacy chains and major employers.
With lobbying heating up in Washington, the Coalition for a [...]

Think that biosimilar legislation will go nowhere this year? Think again. The potential for biosimilars to lower Medicare and Medicaid drug spending could spark support for a follow-on biologics bill this year, if lowered expenditures could offset higher spending elsewhere, FDA Legislative Watch reports.
Under rules that the House applies to pending legislation, any new spending [...]

As the US grapples with a pathway for biogenerics, Health Canada has beat the FDA to the punch and issued a draft guidance. The agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway, FDA News reports. [...]

As promised last month, Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has now introduced legislation that would create a so-called pathway for FDA approval while offering brand-name companies 12 years of exclusivity, plus an extra two years for a medically significant innovation. That [...]

David Snow may be a Republican, but he knows when legislation is in his best interest. And efforts by Democrats to make biogenerics a reality and to create a safety net for millions of uninsured Americans will mean more business for Medco Health Solutions, the pharmacy benefits manager that he runs. Dave doesn’t say who’ll [...]

Some wags say the debate over biologics may not go anywhere this year, but one congresswoman is supposedly on the verge of introducing a bill to resolve the controversy. Anna Eshoo, a Democrat from California - specifically, the region where many biotechs and venture capitalists are based - has drafted legislation that would create a [...]

After nearly a decade of resisting, biotech companies want a law passed this year that lets generic drug companies sell cheaper copies of their medicines. Biotechs, of course, have never had the competition from generics that brand-name drugmakers face when patents expire. While the FDA lacks authority to approve generic biotechs, several bills introduced in [...]

The White House requested a $2.4 billion budget for the agency for the 2009 fiscal year starting in October, up 5.7 percent from 2008. And the Bush administration includes new funds to speed review of generics and new authority to approve biosimilars, which are also sometimes referred to as generic biologics.
Generic drugmakers have been pushing [...]