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 [...]

As the US grapples with a pathway for biogenerics, Health Canada has beat the FDA to the punch and issued a draft guidance.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

Sharply rising expenditures for cancer drugs and other high-priced meds are prompting employers, health plans and pharmacy-benefit managers to redouble efforts to rein in spending, The Wall Street Journal writes. To curb use, payers are pushing for legislation to permit generic drugmakers to sell cheaper versions of biologics, reinforcing rules about trying cheaper therapies first, [...]

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 [...]

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 [...]

Two-thirds of all prescriptions filled in the US are generics, the highest-ever rate, according to figures released by the Generic Pharmaceutical Association. That’s up from 63 percent. Meanwhile, Bloomberg News reminds us that more expensive brand-name meds account for about 80 percent of all dollars spent on prescriptions each year.
The figures, compiled by IMS Health, [...]

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 [...]

In a teleconference chat yesterday afternoon with a few bloggers, Jim Greenwood spent some time sharing the BIO point of view on the pressing matters of the day - follow-on biologics legislation, patent reform legislation and the FDA reform bill, which is otherwise known as PDUFA. Here are some excerpts….
Follow-on Biologics: This is “a critical, [...]

Lawmakers are unlikely to add generic biologics legislation to an FDA bill that’s expected to receive congressional approval this month, two key U.S. congressmen said on Thursday, reports Reuters. Generic drugmakers have been pushing legislation that would chart a specific path for the FDA to approve cheaper copycat versions of biotech meds.
The chances of [...]

The House Ways and Means Committee’s subcommittee on health tomorrow afernoon will hold the latest hearing on biosimilars, otherwise known as generic biologics. The controversial issue is pitting biotech and big pharma against a coalition of insurers, generic drug makers, patient and consumer advocates, and big employers.
Earier today, Pharmalot spoke with Jay Inslee, a Democrat [...]