Rep. Eshoo Introduces Follow-On Biologics Bill; Proposed Pathway for Biosimilars Act is Reportedly Similar to 110th Congress Legislation

By Kurt R. Karst –      

Late yesterday, Rep. Anna Eshoo (D-CA), along with Reps. Jay Inslee (D-WA), and Joe Barton (R- TX), announced the introduction of the Pathway for Biosimilars Act (H.R. 1548).  (A copy of the bill should be available soon).  The introduction of the Pathway for Biosimilars Act follows Rep. Henry Waxman’s (D-CA) introduction of the Promoting Innovation and Access to Life-Saving Medicine Act last week.  We reported on the introduction of the Waxman bill here. 

The new Pathway for Biosimilars Act is reportedly very similar to a bill with the same name introduced by Reps. Eshoo and Barton in the 110th Congress (H.R. 5629).  Our post on the introduction of that bill is available here.  Rep. Inslee has apparently decided not to introduce separate legislation, as he did with the introduction of the Patient Protection and Innovative Biologic Medicines Act in the 110th Congress (H.R. 1956).

According to one press release about H.R. 1548, “[t]he legislation’s formula would offer all new biological drugs a base period of 12 years of data protection with the right to obtain an additional two years once a further indication for use of the product is approved by the FDA.”  We also understand that a period of 6-month pediatric exclusivity would be available.  Additional reactions to the Eshoo/Barton/Inslee bill are available here (BIO), and here (GPhA).

UPDATE:

• A copy of H.R. 1548 – the Pathway for Biosimilars Act – is available here.