In Vivo 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
UsernamePublicRestriction

European SPC Waiver Becomes A Reality With Council Adoption

Executive Summary

Less than a month after it was passed by the European Parliament, a waiver to allow manufacturing of generics and biosimilars during the SPC period, as well as stockpiling for a European ‘day one’ launch upon SPC expiry, has been formally adopted by the European Council.

You may also be interested in...



Industry Prepares For Advent Of SPC Manufacturing Waiver

As the generics and biosimilars industries prepare for the European SPC manufacturing waiver to come into effect on 1 July, Generics Bulletin traces the history of the mechanism from early industry lobbying efforts to its ultimate entry into force.

EU SPC Waiver: Originators May Need To Act Soon

A new EU regulation relaxing the rules on generic and biosimilar manufacturing during a product’s supplementary protection certificate period will take effect on 1 July. Originator companies wanting to benefit from a three-year transition period should consider taking action now.

Formycon Plans Ranibizumab Filings With Ustekinumab And Aflibercept In The Wings

Formycon will follow a US filing for ranibizumab before the end of this year with a European submission early in 2020 as it continues work on biosimilar ustekinumab and aflibercept.

Related Content

Topics

UsernamePublicRestriction

Register

LL1127945

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