Jun 29 2007

Senate panel passes biogenerics bill

Still working on changes

The Senate health committee passed biogenerics legislation Wednesday (June 27) but continues to work on language to encourage pediatric research on biopharmaceuticals, to apply standards for approving biosimilars under biologics law to drug law and to ensure the legislation does not block doctors from prescribing brand biologics when biosimilar versions exist.

The Bush administration is calling for several changes to the legislation (see related story).

The bill is expected to sidestep a floor vote and instead be added to the Senate-passed FDA bill when it goes to conference (see related story). The House FDA bill, which passed committee last week, does not include a biogenerics measure.

The first-ever biogenerics legislation passed by a congressional committee offers a short cut for getting FDA approval of follow-on versions of brand biopharmaceuticals. The bill guarantees that brand companies get at least 12 years without competition from either "comparable" biosimilars or interchangeable biogenerics (see related story).

The legislation was tweaked shortly before mark up to make clear that brand biopharmaceuticals would get only one 12-year period of market protection. Brand companies would not get another 12 years on the same biopharmaceutical if they get additional applications approved for different indications, dosage forms, route of administration or strength.

A bipartisan group of four senators negotiated a deal on the bill before mark up, and some who were not part of the group offered amendments during markup. While none passed, committee leaders signaled they may continue negotiating on some of the ideas prior to conference. Committee Chair Edward Kennedy (D-MA), Hillary Clinton (D-NY), ranking committee Republican Michael Enzi (WY) and Orrin Hatch (R-UT) negotiated the bill.

Sen. Tom Coburn (R-OK) withdrew an amendment after Kennedy agreed to work with him on the measure before conference. The amendment aims to make sure states may let doctors preclude biosimilar substitutions when they prescribe brand biologics.

Kennedy staffer David Dorsey said the amendment would change the definition of "interchangeability," which lets pharmacists substitute biogenerics for brands, and could affect other parts of the bill. Coburn argued it only affects section 2 of the bill.

Clinton said the bill does not force substitution so the amendment is not needed. Hatch said the amendment is a good idea because the bill is silent on substitution.

Coburn also called for the Judiciary Committee to get a chance to mark up the bill. Kennedy said Judiciary Chair Patrick Leahy (D-VT) already agreed to let the health committee take the lead, and the ranking Republican Arlen Specter (PA) only said he wanted to be consulted on the legislation.

Lamar Alexander (R-TN) offered an amendment to apply incentives for drug pediatric research to biopharmaceuticals. It failed 13 to 8 with all Republicans except those in the group of four voting for it.

The amendment would not change the pediatric exclusivity given to drugs. It would only apply it to biologics. Alexander said senators do not need to wait for a study on pediatric exclusivity the bill calls for because the program has successfully increased kid research for drugs over the past decade.

Kennedy said the four senators agreed to the bill's clear-cut 12 years of brand exclusivity because, although many different approaches were discussed, the 12 years gave certainty. He wants to wait for the Government Accountability Office's pediatric research study before fiddling with the agreed-to exclusivity period.

Clinton said FDA already could require research on children under the Pediatric Research Equity Act. She added including the pediatric six-month exclusivity might require that the 12 years exclusivity in the legislation be reduced by half a year.

Enzi said after the markup that committee members will try to find an incentive, other than exclusivity, for pediatric research.

A proposal by Sen. Richard Burr (R-NC) would have applied standards outlined for biosimilars regulated under biologics law to follow-on biologics approved under section 505(b)(2) of drug law.

Some biologics such as insulin are regulated as drugs. The legislation does not make companies with applications for follow-on biologics already at FDA change them. It also lets new versions of products such as insulin continue to be regulated under drug law for 10 years. After that, all biologics would be regulated under biologics law, the Public Health Service Act.

In the meantime, Burr and others such as Coburn want to ensure that follow-on applications under drug law meet the same criteria as follow-ons of biologics regulated under the PHS Act.

Kennedy said the proposal is not politically sensitive and would be worked out.