Scrip 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

China Urged To Stiffen Rules For Approving Biosimilars

This article was originally published in PharmAsia News

Executive Summary

An international drug-maker group called on China to toughen its review process for biosimilars to reduce the current "significant risks" with the ones it approves.

You may also be interested in...



International Harmonization: Not Just For Audits Anymore

The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.

Reddy’s Settles On $7bn Revlimid But Natco Maintains The Lead

Dr Reddy’s Laboratories has become the third Revlimid ANDA sponsor to settle patent litigation action with Bristol Myers Squibb’s Celgene. However, the Indian company will join Alvogen in not being able to launch before first settler Natco, which has partnered with Teva’s Watson.

Strides Readies SteriScience For Injectables Push

Strides is expanding its presence in synthetic injectables via a new company, SteriScience, while keeping its biologics injectables business under Stelis. A head start with existing IP assets and those from a new joint venture with Brooks Labs will enable the fledgling firm to file its first ANDA in fiscal 2021, with break-even foreseen in two years.

Topics

UsernamePublicRestriction

Register

LL1133951

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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