Scrip is part of the Business Intelligence Division 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


Japan Posts Draft Guidance On Biosimilars; Seeks Public Comment

This article was originally published in PharmAsia News

Executive Summary

TOKYO - Japan's Ministry of Health, Labor and Welfare Sept. 17 posted draft guidance on follow-on biologics, or biosimilars, a move that could make Japan among the first group of large economies to set a safety and regulatory framework for the new copycat breed of biologic therapies

Related Content

Merck Eyes Emerging Biosimilars Market In Japan
Sandoz Launches Japan's First Biosimilar; Sees Huge Market Potential In Japan
Sandoz's Somatropin Becomes First Biosimilar Approved In Japan
Biosimilar Launch Strategy: Reinforce Safety Profiles In Asia – BIO Conference
Japan Chemical Research, Kissei Submit First Biosimilar Application In Japan
Fresh Concerns Over Biosimilar ESA Use In Thailand Raises Takeda’s Hematide Prospects
Malaysia Releases Regulatory Guidance On Biosimilars, But Local Manufacturers Not Ready To Produce - Analyst
Malaysia Proposes Biosimilars Guidance
PhRMA Urges Japan To Create Separate Regulations For Biosimilars
Indian Firms Look To Cash In On Growing Demand For Biosimilars



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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