Biosimilars brd v2

Hinweis der Redaktion

1. Four currently pending bills – each complex, each different First – Waxman Senate bill 1695 bipartisan effort led by HELP, Senate committee on Health Education Labor and pensions 4 th Eshoo house bill is least complicated Bills have similarities and differences
2. Previously proposed legislation differed on whether to amend the FDCA or PHSA …and away we go
3. Not interchangeable means new active ingredient
4. Peds extension: House version, extension is in the legislation Senate version amends subsection (a)(1) of 409I of PHSA and § 505A(p) of FDCA
5. FOB market exclusivity provided in the legislation – varies HW - 180 days from first commercial marketing differs when litigation ensues Inslee, like EP provides not FOB exclulsivity; Others require interchangable label.. None yet
6. Each of the new bills varies the HW model of generics; but there is no plan for an ORANGE book. Instead, parties will exchange patent information and be provided with access to confidential information as needed to determine infringement. Only HR5629 addresses the rights of third parties, e.g., Universities and other parties that may have an interest in the patents. None provides for an automatic stay of approval for patent litigation, nor provides for control of patent litigation
7. Senate—20 days; House—30 days Senate also requires identification of the patents on the list that the RPS would be prepared to license to the applicant
8. House is 45 days for RPS or 3d party, Senate is 60 days House version does not require (i) or that (ii) is on a claim by claim basis
9. (iv) Same as (A)(iii) – if new patent then must furnish within 30 days