In coming years, nearly half of all newly approved drugs could come from biotechnology. With stakes so high, Congress is working to create a more direct pathway for the FDA to approve "biosimilars", the generic or "follow-on" versions of biologics. Two bills before Congress approach the issues differently.
With stakes so high, Congress is working to create a more direct pathway for the Food and Drug Administration (FDA) to approve "biosimilars," the generic or "follow-on" versions of biologics. Two very different proposals are now before the legislature.
Making follow-on versions of biologics will be far more difficult than making generic versions of traditional drugs. CRS noted, "typical pharmaceutical products consist of small molecules, on the order of dozens of atoms, that may be readily characterized and reproduced through well-understood chemical processes. In contrast, biologics are often made up of millions of atoms, feature a more complex structure than traditional pharmaceuticals, and are manufactured from living cells through biological processes."
Advocates say it's hard to know whether Congress can reach a deal this year. On the one hand, there are still big differences between the bill supported by the biologics industry and the one supported by the generics industry and some patient advocates. In addition, Congress has other big issues on its plate, including energy overhaul and healthcare reform.
On the other hand, according to lobbyists on both sides, members of Congress are talking about grafting a biosimilars bill onto the healthcare reform bill, which Democrats and the President vow to move this year. In addition, the Obama administration supports the biosimilars legislation and has put it into its budget projections; the economy is providing more pressure to save money with biosimilars; and Rep. Henry Waxman (D-Calif.), a major advocate for the more generics-friendly proposals, has moved into the powerful position of chair of the House Energy and Commerce Committee, a key committee for healthcare.
Katie Huffard, executive director of the Coalition for a Competitive Pharmaceutical Market (CCPM), said there are signs the issue will heat up soon in Congress, and legislators have been asked to set aside major chunks of time for it. In addition, she said, the last Congress has already educated many key players on the issues. Beyond that, Huffard and others say, pressure is building, because the European Union is moving ahead with a biosimilars pathway passed several years ago and several biosimilars are already approved.
In June, Waxman released a letter asking the Obama administration to consider how it can prepare now for the legislation's passage, saying, "The speed of FDA's action will determine how quickly safe and effective generic biologics become available to patients."
This year in Congress, the biologics industry supports HR 1548, sponsored by Rep. Anna Eshoo (D-Calif.), which would make it more difficult to market biosimilars than would alternative legislation. Among other things, it would give innovative biologic products 12 years of data "exclusivity," the time in which a company may not rely on preclinical, clinical, or other data submitted by another company seeking FDA approval.
The generics industry and some patient advocate groups support HR 1427, sponsored by Waxman, which would allow exclusivity of five years with three years for certain modifications of products. On the Senate side, Sen. Charles Schumer (D-N.Y.) has introduced S 726, legislation identical to Waxman's.
It's also expected that Sen. Edward Kennedy (D-Mass.), chair of the Senate Health, Education, Labor and Pensions Committee, will introduce a biosimilars bill. He sponsored the bill that would have provided 12 years of exclusivity; it passed his committee unanimously in 2007.
The current bills also differ on when a biosimilar would be considered "interchangeable," that is, eligible under state law to be substituted by a pharmacist or an insurer for the original product prescribed by a physician.