Pink Sheet 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

UsernamePublicRestriction

Industry Laments UK Change To SPC Waiver Approach

Manufacturing Of Products Under SPC Only Allowed For Non-EU Markets

Executive Summary

Changes to how the UK plans to implement the supplementary protection certificate manufacturing waiver after it separates itself fully from the EU following the current Brexit transition period have been criticized by the generics industry, while originators have welcomed the move.

You may also be interested in...



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.

Organon And Henlius Complete Phase III For Denosumab

Having earlier this year reported positive Phase I data for their partnered denosumab biosimilar candidate, Organon and Shanghai Henlius Biotech have now announced that their HLX14 version has met primary endpoints in a Phase III study.

Entries Begin To Roll In For 2024 Industry Awards

Entries have now begun rolling in for the Global Generics & Biosimilars Awards, which returns to Milan this October, Free to enter and attend, the ceremony recognizes the top achievements across the generics, biosimilars and value added medicines industries.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS142635

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