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


Roche Lashes Out At Biosimilars Regulations In Emerging Markets, Calls For Stricter Pharmacovigilance Of Launched Products

This article was originally published in PharmAsia News

Executive Summary

MUMBAI - Roche - maker of blockbuster biotech products like Avastin and Mabthera - has called for a stricter regulatory and approval mechanism for biosimilars being launched in markets like India even as the European Union rolled out its draft guidelines for developing biosimilar versions of complex monoclonal antibodies Nov. 26 (EU Draft Guidelines On Biosimilar Antibodies Go Easy On Generics Firms, But Originators Need Not Panic, The Pink Sheet DAILY, Nov. 29, 2010)

You may also be interested in...

Battleground Herceptin: Biocon, Mylan Take Roche Head On With Appeal In Delhi Court

After being stung by a restraining order related to regulatory approval for biosimilar versions of Herceptin, Biocon and Mylan are appealing a Delhi Court decision that favored Roche.

As New Biosimilars Roll Out, Indian Biotech Group Raises Quality Concerns

Leading biotech group ABLE cautioned the government that India should not become a dumping ground for low-quality biosimilar products. The group pointed at several concerns related to Cipla’s latest launch of Enbrel copies.

India’s Biosimilars Guidelines Lay Out Best Practices But Marketed Products Not To Be Reviewed – BIO Conference

The guidelines will enable a standardized biosimilars pathway as opposed to case-by-case application reviews

Related Content




Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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