Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Biosimilar Legislation Could Upend Interchangeability Rather Than Prevent Product Hopping

Executive Summary

Rep. Kurt Schrader’s bill could allow a first interchangeable product to block all strengths with its one-year exclusivity, rather than just the one developed.

You may also be interested in...

505(b)(2)-Like Pathway For Biologics May Gain Renewed Interest With Senate User Fee Bill Pending

Draft legislative text would allow some biologics and biosimilars to rely on published literature or other information and avoid some clinical studies, but the wide FDA discretion also included could raise more questions.

Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill

Legislation in development also could create an option for tentative approval of interchangeable biosimilars.

Clinical Trial Diversity Measures Primed For Inclusion In US FDA User Fee Legislation

House subcommittee hears testimony on merits of various proposals to increase diversity of clinical trial participants; whether lawmakers ultimately favor measures that impose enforceable obligations on sponsors, or merely incentivize more diverse enrollment, remains to be seen.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts