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Partnerships driving similar biologics development in India

Biosimilars/Research | Posted 29/01/2016 0 Post your comment

With biosimilars grabbing an increasing share of the global biologicals market and with India providing a cheaper place to carry out research and development, more international players are partnering with Indian companies.

In a review of ‘similar biologics’ in India, author Malipatil investigates some of the partnerships that have been forged in India in recent years [1].

Given the potential gains to be made, many companies are eager to enter the Indian similar biologics market or indeed the global biosimilars market. However, companies may lack the resources and experience required to successfully develop, manufacture and commercialize biologicals causing them to look towards partnership agreements as a solution.

Some of the partnership deals entered into in recent years are outlined in Table 1.

Table 1: Key partnership deals made with Indian companies 2010‒2015

Indian company	Partner	Product(s)	Type of deal	Details	Date
Strides Arcolab	Oncobiologics (USA)	Follow-on biologicals	Partnership	Strides made a 'series of strategic investments' in Oncobiologics [2]	Jul 2014
Cipla	Mabpharm (India)	Monoclonal antibodies	Majority acquisition	Cipla subsidiary Meditab Specialities acquired the remaining 75% stake in Mabpharm [2]	Jul 2014
Serum Institute	NeuClone (Australia)	Monoclonal antibodies	Licensing agreement	The licensing agreement and joint development partnership covers the manufacture and supply of 10 follow-on monoclonal antibody drugs globally for the treatment of diseases such as cancer and autoimmune disorders [2]	Jun 2014
IPCA Labs	Oncobiologics (USA)	Monoclonal antibodies	Partnership	The deal creates a two-part alliance for the development, manufacture and commercialization of follow-on monoclonal antibodies [3]	Jun 2014
Agila Biotech	Pfenex (USA)	Follow-on biologicals	Partnership	The companies will develop, manufacture and commercialize an initial pipeline of six follow-on biologicals for the global market [4]	Apr 2013
Biocon	Mylan (USA)	Insulin analogues	Partnership	Mylan will have the rights to develop and market Biocon’s follow-on insulin analogue products, with both companies sharing development, capital and certain other costs to bring the products to market [5]	Feb 2013
Ranbaxy	Epirus (USA)	Infliximab follow-on biologicals	Licensing agreement	Epirus will develop and supply BOW015, and upon regulatory approval Ranbaxy will market the ‘similar biologic’ in India and other emerging markets, including South East Asia and North Africa [6]	Jan 2013
Biocon	CCM Pharma (Malaysia)	Insulin follow-on biologicals	Licensing agreement	The deal gave CCM exclusive license and distribution rights to market, sell and distribute a range of Biocon’s insulin products in Malaysia and Brunei [7]	Dec 2012
Lupin	NeuClone (Australia)	Cell line technology	Partnership	NuClone to transfer technology for proprietary mammalian Chinese Hamster Ovary (CHO) cell lines [8]	Jun 2011
Intas Biopharma	Apotex (Canada)	GCSF and PEG-GCSF	Partnership	Agreement to develop follow-on biologicals including filgrastim and pegfilgrastim [9]	Jun 2011
Inbiopro Solutions	Strides Arcolab (India)	Follow-on biologicals	Majority acquisition	Strides partnered with Inbiopro to commercialize its similar biologic pipeline products [10]	Dec 2010
Biocon	Pfizer (USA)	Insulin and analogues	Partnership	Biocon entered into an exclusive agreement with Pfizer to commercialize several of Biocon’s insulin product globally. The deal fell apart in March 2012 [11]	Oct 2010
DM Corporation	Orf Genetics (Iceland)	Human recombinant therapeutic proteins and follow-on biologicals	Joint venture	Joint venture to develop and market human recombinant therapeutic proteins and biosimilars [10]	Sep 2010
Cipla	Biomab (Hong Kong)	Monoclonal antibodies	Minority acquisition	Acquisition of 25% stake in Biomab [10]. Stake bought back by Biomab in October 2015.	Jun 2010
Ranbaxy	Pfenex (USA)	Expression technology	Development agreement	Development of follow-on biologicals using Pfenex expression technology platform [10]	Mar 2010
Ranbaxy	Biovel Life Sciences (India)	Follow-on biologicals	Majority acquisition	Ranbaxy acquired product rights and manufacturing facility in Bangalore, India from Biovel Life Sciences [10]	Jan 2010

These biologicals partnership deals typically have one or more of the following goals:

Market access in emerging or developed markets
Diversifying into or enhancing existing follow-on biological portfolios
Accessing expertise in follow-on biologicals development, manufacturing, and/or commercialization
Reducing development and manufacturing costs.

Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

Low costs and less stringent regulatory requirements in India

Factors affecting the uptake of ‘similar biologics’ in India

Regulation and uptake of ‘similar biologics’ in India

References
1. Malipatil NB, Haridas KM, Shruthi DP. Biosimilars and regulations: a review. J Pharm Biomed Sci. 2015;05(06):453-68.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars deals coming thick and fast [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Biosimilars-deals-coming-thick-and-fast
3. GaBI Online - Generics and Biosimilars Initiative. Oncobiologics and IPCA create biosimilars alliance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Oncobiologics-and-IPCA-create-biosimilars-alliance
4. GaBI Online - Generics and Biosimilars Initiative. Agila Biotech and Pfenex make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Agila-Biotech-and-Pfenex-make-biosimilars-deal
5. GaBI Online - Generics and Biosimilars Initiative. Mylan and Biocon to partner on insulin products [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Mylan-and-Biocon-to-partner-on-insulin-products
6. GaBI Online - Generics and Biosimilars Initiative. Epirus and Ranbaxy sign agreement for infliximab ‘similar biologic’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Epirus-and-Ranbaxy-sign-agreement-for-infliximab-similar-biologic
7. GaBI Online - Generics and Biosimilars Initiative. CCM and Biocon make biosimilar insulin deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/CCM-and-Biocon-make-biosimilar-insulin-deal
8. GaBI Online - Generics and Biosimilars Initiative. Lupin and Neuclone biosimilars agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Neuclone-biosimilars-agreement
9. GaBI Online - Generics and Biosimilars Initiative. Apotex pegfilgrastim biosimilar under FDA review [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Apotex-pegfilgrastim-biosimilar-under-FDA-review
10. GaBI Online - Generics and Biosimilars Initiative. Biotech growth and biosimilar opportunities in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/General/Biotech-growth-and-biosimilar-opportunities-in-India
11. GaBI Online - Generics and Biosimilars Initiative. Pfizer and Biocon’s biosimilar insulin deal is off [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jan 29]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-and-Biocon-s-biosimilar-insulin-deal-is-off

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