Rep. Waxman Introduces Follow-On Biologics Bill; Legislation Hews Closely to Hatch-Waxman Exclusivity Paradigm

March 11, 2009

By Kurt R. Karst –      

Earlier today, Representative Henry Waxman (D-CA) (along with Representatives Nathan Deal (R-GA), Frank Pallone (D-NJ), and Jo Ann Emerson (R-MO)) announced the introduction of H.R. 1427, the Promoting Innovation and Access to Life-Saving Medicine Act, which authorizes FDA to approve abbreviated applications for so-called “biosimilar” and “biogeneric” biological products.  According to the bill, “biosimilar” products are comparable to the innovator product and “biogenerics” are therapeutically interchangeable with the innovator.  Rep. Waxman introduced another bill in the 110th Congress with a similar name (H.R. 1038 – the Access to Life-Saving Medicine Act); however, that version did not provide for any period of market exclusivity for innovator products – only a period of 180-day exclusivity for the first interchangeable biological product. 

Under the new version of the bill, which adds “Promoting Innovation” to its title, an original product with a novel molecular structure would be entitled to 5 years of market exclusivity, and a modification of a previously approved product would be entitled to 3 years of market exclusivity.  This exclusivity scheme is similar to the current regime for drug products approved under the FDC Act and created by the Hatch-Waxman Amendments – a model that Boston University Economics Professor Laurence J. Kotlikoff suggested be used in a 2008 paper.  The 5- and 3-year periods under the Waxman bill could be extended by up to 1 year if the applicant establishes that the product can be used for a new disease indication or conducts pediatric studies.  However, market exclusivity would be reduced by 3 months for a “blockbuster” product (i.e., combined U.S. annual gross sales exceeding $1 billion). 

The bill would also provide for a period of first biogeneric exclusivity.  Specifically, the first biogeneric applicant to demonstrate interchangeability with a reference product would receive a period of 180-day market exclusivity during which FDA could not approve another generic interchangeable product, as well as an authorized generic version of the innovator’s product (termed as a “rebranded interchangeable biological product” in the bill).  Under the bill, a product found to be interchangeable could be safely substituted for the original product (if such substitution is permitted by state law). 

As with several other follow-on biologic bills introduced in the 110th Congress, Rep. Waxman’s bill would establish a complex patent resolution procedure.  Under the new bill, patent disputes can be resolved before a biosimilar product is approved.  In addition, the bill would create penalties for failure to litigate patents in a timely fashion. 

Under the Waxman bill, FDA would have full scientific discretion to determine what studies – including clinical studies – are necessary to establish that a biosimilar product is as safe and effective as the original product, and that a biogeneric is interchangeable with the original product. 

Rep. Waxman’s bill is the first follow-on biologics bill introduced in the 111th Congress.  It seems likely that other bills will follow, including perhaps a new bill from Reps. Anna Eshoo (D-CA) and Joe Barton (R-TX), who, as we previously reported, introduced the Pathway for Biosimilars Act last year.  That bill provided for a substantially longer period of innovator market exclusivity. 

Categories: Hatch-Waxman