India released "Guidelines on Similar Biologics"

India pavilion at 2012 BIO International Convention was inaugurated by Dr M K Bhan, Secretary, DBT on 19 June 2012 jointly organised by CII, ABLE and the Department of Biotechnology, Govt of India. All together 25 exhibitors representing different verticals of biotech industry participated at the India pavilion.
Dignitaries like Dr Kiran Mazumdar Shaw, CMD, Biocon Ltd, Mr. James C. Greenwood, President and CEO Biotechnology Industry Organization (BIO); Mr S Raghavan, Joint Secretary, DBT; Ms Anuradha Mitra, Joint Secretary and Financial Adviser, DBT ; Dr Madan Mohan, Adviser, DBT were present in the inaugural function.
On the sidelines of BIO2012, a press conference was organised to release the Guidelines on Similar Biologics.

• The guidelines were jointly prepared by Dept of Biotechnology, Ministry of Science and Technology and Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, Government of India in consultation with industry and other key stakeholders.
• These guidelines provide insights into preclinical evaluation of those recombinant products that are claimed to be already approved biopharmaceutical products, referred as “ similar biologics” and therefore partly rely on the data from the already approved products for approving safety, purity, potency and effectiveness

http://indiaeducationdiary.in/Shownews.asp?newsid=13749

Dr Reddy's, Merck Serono in pact to develop Biosimilars

Dr Reddy's Laboratories and Merck Serono, a unit of Germany's Merck KGaA, have entered into a partnership to co-develop a portfolio of biosimilar compounds in the oncology segment

As per the deal, the two companies will co-develop the molecules included in the agreement. Dr Reddy's will lead early product development and complete phase I, and then Merck Serono will take over manufacturing of the compounds and will lead phase III development
The agreement is based on full R&D cost sharing

It will also handle commercialisation in large parts of the world and will pay Dr. Reddy's royalties.
http://www.business-standard.com/india/news/german-pharma-cosdr-reddys-to-cooperatebiosimilars/166952/on

Biotech body criticises Bayer on cancer drug

The All India Biotech Association – Southern Chapter (AIBA-SC) has come out strongly in favour of the Indian Patents Office order in favour of Natco Pharma Ltd.
The association has criticised Bayer for not agreeing to the “fair decision”.
http://www.thehindubusinessline.com/companies/article3412659.ece?ref=wl_opinion

Biocon-Mylan collaboration drug portfolio worth $33 bn

Biocon in an investor presentation has revealed that it is sitting on a potential $33 billion portfolio of biosimilar drugs that will expire by 2015

The two companies are planning to come out with biosimilars such as "Trastuzumab, Peg-filgrastim, Bevacizumab, Adalimumab and Eternacept", which could be used in treating various ailments including cancer and psoriasis.
http://www.business-standard.com/india/news/biocon-mylan-collaboration-drug-portfolio-worth-33-bn/164500/on

Bayer challenges Nexavar generic licence order

In March this year, India had invoked a law permitting Hyderabad-based Natco Pharma to manufacture and sell cancer-treatment drug Nexavar at a price over 30 times lower than charged by its patent-holder Bayer Corporation
In his order, Controller of Patents PH Kurian had said the move followed Bayer not doing enough to scale up the sale of the drug despite getting patent for it in India in 2008
http://articles.economictimes.indiatimes.com/2012-05-07/news/31610564_1_drugmaker-bayer-indian-patent-act-cancer-drug