Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

UsernamePublicRestriction

Apotex's Neulasta, Neupogen Biosimilars Clear Legal Hurdles, But Approval Questions Remain

Executive Summary

Federal appeals court affirms ruling that Apotex's biosimilars do not infringe Amgen's manufacturing process patent, but its applications have stalled at FDA for the past three years.

You may also be interested in...



Biosimilar Legal Landscape: Lessons From 2017

In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.

Biosimilar Legal Landscape: Lessons From 2017

In several firsts last year, US Supreme Court ruled on BPCIA, Amgen won a damages award in infringement litigation, and Amgen and Mylan inked deals clearing way for future launch of Humira and Herceptin biosimilars. Chart includes status of 15 cases and questions teed up for courts to tackle in 2018.

India’s USV Joins Line-Up For Biosimilar Neulasta In Europe

USV has joined the list of firms seeking clearance for biosimilar pegfilgrastim in Europe. Managing director Prashant Tewari says the company is “well geared” to address potential price competition and maintains that biosimilarity of USV’s pegfilgrastim with the innovator product has been established “satisfactorily”.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS121964

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

Cancel