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 [...]

We are particularly happy, especially after our difficulties yesterday. You may have noticed sporadic posting, which was due to a burst pipe valve in the basement of the Pharmalot headquarters, a disruption assuaged only by our on-call Pharmalot maintenance crew. The problem has been solved, although we look forward to a respite. Nonetheless, there is [...]

As the US grapples with a pathway for biogenerics, Health Canada has beat the FDA to the punch and issued a draft guidance.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. [...]

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 debate over generic biologics, which some call follow-on biologics, just took an interesting turn. Although the White House budget would give the FDA new funds to approve such drugs, various companies remain frustrated with the lack of a sanctioned FDA-approved pathway, which is needed before copycat versions of these expensive meds can be developed [...]

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 [...]

We are posting our usual round-up a wee bit early this evening due to a speaking engagement, of all things. The New Jersey Intellectual Property Lawyers Association - that’s right, a group of patent lawyers - has asked us to chat about patents and how these are perceived by the media and the public. We [...]