Indian firms seek a higher profile in biosimilars

Generics/Research | Posted 12/02/2010 post-comment0 Post your comment

As reported by Anju Ghangurde in Scrip News of 13 January 2010, large Indian companies appear to be keen to develop their capacities and capabilities in the biosimilars segment, an area expected to take centre stage globally in the coming years. Some of this growing interest is being attributed to the projected decline in the global pipeline for generic small molecules by about 2013, as well as optimism that some large markets such as the US will soon put in place regulations to facilitate the entry of biosimilars.


Ms Ghangurde writes that most Indian companies are expected to opt for the alliance route at some point to develop their biosimilars businesses. Recent interest in the segment has come from Ranbaxy Laboratories (now part of Daiichi Sankyo) that is said to be in the fray to acquire the Indian biotech firm Biovel Life Sciences at Bangalore, focused on the R & D, manufacturing and marketing of biogenerics, ‘biosuperiors’ and other biopharmaceuticals. Ranbaxy has declined to comment on market speculation, although some local reports have confirmed that Ranbaxy is among those interested in Biovel.

She reports that Navroz Mahudawala, Associate Director (transaction advisory services) at Ernst & Young, said that while the integration and deal flow between pharmaceuticals and biotech was high globally, it remained limited in India. "Biosimilars are a difficult capability to develop and while the opportunity is immense, most Indian entrepreneurs are aware that the route may well be achieved more effectively through the inorganic route", Mr Mahudawala told Ms Ghangurde.

Ms Ghangurde reports that other large Indian companies developing capabilities in the biosimilars space include Dr Reddy's Laboratories, Lupin and Cipla. About US$40 billion worth of biologicals are expected to face ‘genericisation’ by 2014, according to a report by Ernst & Young and the Organisation of Pharmaceutical Producers of India.

Dr Reddy's, which has already launched versions of the antibody product rituximab (marketed as Reditux) and the granulocyte colony-stimulating factor (G-CSF) filgrastim (Grafeel) in India, has about eight generic biopharmaceuticals under development. The company, which is expected to launch around two products this year, views generic biopharmaceuticals as an integral part of its mid- to long-term growth strategy. It is looking to build depth in its development and manufacturing capabilities to access this opportunity, he writes.

Lupin, which is making ‘modular’ selected investments in the area of biosimilars, expects to target the domestic and other emerging markets in the first phase, and advanced markets in the second and third phases. The firm said that the second phase would see the development of biosimilars in the microbial area and the third in the mammalian area. The company has noted that it is open to alliances, including for clinical development. The Teva-Lonza type of partnership for biosimilars, announced in 2009 was attractive to Lupin, with the Indian company suggesting interest in something similar or ‘even better’. Last year, Cipla also outlined plans for an entry into the biosimilars segment through a joint venture with an unidentified Chinese partner. This followed the termination of its previous alliance for biopharmaceuticals with the domestic company, Avesthagen. Cipla expects to be ready with certain monoclonal antibodies by 2011, Ms Ghangurde writes.


Anju Ghangurde. Indian firms seek a higher profile in the biosimilars sector. Scrip News. 2010 January 13.

Source: Scrip News

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