Roche link with Emcure for biologics manufacture may signal strategic shift

Is there a major strategic shift underway at Roche, a world leader in biotechnology? Probably yes, if the Swiss giant's latest alliance with an Indian firm, Emcure, to manufacture some of its best known biologics in India is anything to go by.

Industry watchers say that the move is significant, given that it clearly indicates that Roche is perhaps keen to balance affordability and price in large markets like India, for which local cost-effective manufacturing could prove vital. Improved access to its products is another outcome, something that will hold Roche in good stead given that NGOs and activists have been rather unforgiving against multinationals whose innovative products have been beyond the reach of some patients, though price is not the only reason for this.

The price factor has also been taken into account in several Indian court cases concerning medicines in the past.

Emcure told Scrip that Roche is probably the first company to conduct such an initiative for innovative biologics in India. "Roche's vision is to increase the availability of their innovative products to patients in India and also for them to have the standard care of therapy that they deserve as in the many parts of the world," Emcure's director, business development, Mukund Ranade, said.

Emcure's wholly owned subsidiary Gennova Biopharmaceuticals already has a portfolio of at least four biologics - tissue plasminogen activator, granulocyte macrophage colony stimulating factor, human erythropoietin and pegylated granulocyte colony stimulating factor - developed and commercialised in India, its website notes.

Mr Ranade explained that Roche's partnering effort would increase access to Roche's medicines in India and enable access for a "large majority" of patients who currently pay out of pocket, while partnering with the government would enable increased access to Roche products for people in need.

"With this strategy, we expect to significantly increase the number of patients treated with Roche therapies and help patients currently under treatment to continue to use Roche products properly (as recommended in the package insert)," he said.

Mr Ranade added that both Roche and Emcure will also invest in patient access programmes and "encourage" both public and private insurance coverage to increase.

Details on how Roche/Emcure plan to partner with the government or when the first products from the new alliance may be ready for market were not immediately available, though an international publication suggested these could include Herceptin (trastuzumab) and Pegasys (pegylated interferon).

Pegasys was the first product to receive a product patent in India back in 2006 and at that time the treatment cost of the product for 24 weeks' therapy was approximately Rs250,000 ($5,074), which also included support in the form of diagnostic tests and ribavirin.

Roche's plans also perhaps indicate the arrival of Indian outsourced manufacturing in the biologics segment, though it's unclear if Emcure will get any waiver for regulatory studies for these biologics given its partnership with the innovator. The head of an Indian firm with interests in the biosimilars space said that rules should be uniform for all players and that no concessions should be offered.

Another official, who declined to be identified, added another dimension, suggesting that local manufacture was becoming more important for multinationals for several reasons, including to satisfy the "working" of patented products in India as required under local patent laws.

The issue of what constitutes working of a patent has been controversial and complex, with Indian and multinational firms having their own polarised interpretations. Roche has told Scrip in the past that its products were being worked on a commercial scale to the "full extent" in India, and that importation of a patented product constitutes working of the patented product in the country (scripintelligence.com, 25 May 2011).