Congress revisits plans to approve generic biologics

President Obama's budget proposal anticipates that an approval pathway for these drugs would save $9.2 billion over a decade.

By Doug Trapp — Posted March 30, 2009

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Two competing bills reintroduced in March would create an approval process for generic biopharmaceuticals, but the measure favored by brand-name drugmakers so far has attracted more support from House members.

Unlike Europe, the U.S. has no standard approval process for generic biologics, often called follow-ons or biosimilars. The Food and Drug Administration examines applications for generic biologics on a case-by-case basis, applying different sections of law depending on the nature of the particular drug.

In recent years, lawmakers have offered legislation to create a single pathway for generic biologics. The goal is to allow faster approval of generic versions of expensive cancer-fighting treatments and other medications and to make them more affordable. But lawmakers have been unable to agree on a few key points, including the length of time manufacturers of an original drug would be protected from generic competition.

The Generic Pharmaceutical Assn. is hoping members of Congress will embrace the Promoting Innovation and Access to Life-Saving Medicine Act, reintroduced March 11 by Rep. Henry Waxman (D, Calif.), chair of the House Energy and Commerce Committee. The bill would give original biologic drugmakers an initial five years to market their drugs without generic competition, and it would allow an extension of up to an additional four years.

Kathleen Jaeger, GPhA president and CEO, said the Waxman bill is based on the standards of the 1984 Hatch-Waxman Act, which created an approval process for generic versions of chemical drugs. "For health care to be affordable and sustainable, this bill needs to pass," she said. Waxman's bill has seven co-sponsors. The GPhA and several business and labor organizations support the bill.

The Pathway for Biosimilars Act, reintroduced March 17 by Rep. Anna Eshoo (D, Calif.), initially would provide 12 years of exclusive marketing to original biologic drugmakers, which could be extended by up to an additional 2½ years. That measure has 54 co-sponsors and also is supported by the Biotechnology Industry Organization.

"This new biosimilars approval pathway will promote innovation, competition and lower prices but also ensures that patients are given safe and effective treatments that have been subjected to thorough scrutiny and testing by the FDA," Eshoo said.

Sen. Edward Kennedy (D, Mass.) also plans to reintroduce his generic biologics bill, said a spokesperson from the Senate Health, Education, Labor and Pensions Committee, which Kennedy chairs. His measure from the last Congress, which the HELP panel approved in 2007, would have allowed 12 years of exclusive marketing.

The American Medical Association has not taken a position on the bills. But the Association is concerned about any measure's effect on patient safety, incentives for innovation and physicians' independence. Legislation should not compel doctors to treat generic biologics as interchangeable with brand-name biologics and should balance the need for market exclusivity with competition, according to the AMA.

President Obama's 10-year budget proposal anticipates that Congress will adopt a pathway for generic biologics that gives original drugmakers seven years of exclusive marketing, according to Office of Management and Budget spokesman Tom Gavin. The president's savings estimate of $9.2 billion over a decade is based on a review of several previous generic biologic bills.

Eshoo's measure is similar to the one she sponsored in the last Congress, but Waxman's previous version did not provide an exclusive marketing period for original biologic drugmakers. BIO President and CEO Jim Greenwood said Waxman has listened to some of his concerns but that Waxman's new bill doesn't protect biologic drug research enough.

The nation's recession drastically has affected the ability of biotech companies to find funding, Greenwood said. The number of initial public offerings from biotech firms nosedived from 35 IPOs in 2007 to one IPO and 17 withdrawals in 2008, according to Deloitte ReCap, which tracks the biotech industry.

The current Waxman and Eshoo bills also differ on how to determine interchangeability, or the ability to substitute a follow-on for an original biologic at the pharmacy. Greenwood said BIO prefers a blanket ban on interchangeability because of patient safety concerns.

But GPhA's Jaeger said a generic biologic bill shouldn't be overly prescriptive on the issue. "Let the FDA, who has the expertise, decide what the appropriate science is and what the appropriate criteria should be."

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Two roads to generic biologic drugs

Two lawmakers reintroduced separate legislation in March to create an approval process for generic biopharmaceuticals. Generic drug companies favor a bill by Rep. Henry Waxman (D, Calif.), the Promoting Innovation and Access to Life-Saving Medicine Act, while brand-name biologic drugmakers support the Pathway for Biosimilars Act by Rep. Anna Eshoo (D, Calif).

Market exclusivity for original biologic drug

Eshoo: At least 12 years and up to 14½ years.
Waxman: At least 5 years and up to 9 years.

Interchangeability (at pharmacies)

Eshoo: Allowed if the Food and Drug Administration finds no safety risks or diminished efficacy concerns.
Waxman: Allowed if the FDA approves it, with exact standards to be determined within 2 years of bill adoption.

Market exclusivity for first interchangeable generic biologic

Eshoo: 2 years.
Waxman: At least 6 months.

Clinical trials for generic biologics

Eshoo: Required unless the FDA issues a waiver.
Waxman: Required only if the FDA orders it.

Source: Bill text, bill sponsors

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