Pathway for Biosimilars Act
To amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, and for other purposes.
previous 110th session of congress Other Bill Titles (2 more) 3/13/2008--Introduced.
Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).
Requires the Secretary of Hea... more
Committees
Amendments
This bill has no amendments.
Bill Status
| Introduced | ![]() | Voted on by House | ![]() | Voted on by Senate | ![]() | Considered By President | ![]() | Bill Becomes Law |
| March 13, 2008 |
In the News
March 26, 2008 New US biosimilars bill a disappointing distraction, says GPhA
HR 5629, the bipartisan Pathway for Biosimilars Act introduced in the House by Representatives Anna Eshoo (Democrat, California) and Representative Joe ...
March 18, 2008 California Healthcare Institute Supports Introduction of ...
... March 14, to Congresswoman Anna Eshoo (D-Menlo Park) commending her for the introduction of HR 5629, the “Pathway for Biosimilars Act,” legislation that ...
Blog Coverage
January 04, 2009 Patent Docs: Top Stories of 2008: #9 to #6
Five follow-on biologics bills were introduced during the 110th Congress: H.R. 1956 (which provides twelve years of data exclusivity and two years of market exclusivity), S. 1695 and H.R. 5629 (which provide four years of data ...
Source: Patent Docs
January 02, 2009 Patent Docs: Teva CEO Predicts Passage of Follow-on Biologics Bill ...
We also reported last summer that the Biotechnology Industry Organization (BIO) indicated that either H.R. 1956 (providing fourteen years of exclusivity), H.R. 5629 (providing twelve years of exclusivity), or S. 1695 (also providing ...
Source: Patent Docs
December 14, 2008 GoozNews: Biosimilars, Biogenerics Not the Same
Anna Eshooâs H.R.5629 each call for testing drugs for safety, purity and âpotency.â The FDA uses potency as a synonym for efficacy. In other words, all three bills would mandate clinical trial effectiveness testing â the expensive ...











