In an interesting turn of events, Roche Holdings AG has entered into an alliance with Emcure to make generic versions of some of its top-selling monoclonals. Reports appeared in the first week of March that the Swiss drugmaker decided to transfer the technology to manufacture patented anti-cancer products including Herceptin and MabThera to the Indian CMO .

Roche has been engaged in a relentless battle to safeguard its IP rights from a rising number of generic makers in India. Since 2006, when the innovator obtained the first product Patent (incidentally, the patent was also the first of its kind after India started honoring product patents in 2005) for pegylated interferon alfa-2a (Pegasys), the company has involved in at least a dozen patent infringement disputes in Indian courts.

Roche also succeeded against a lawsuit questioning the legitimacy of the patent granted for Pegasys. However, the company has found it extremely tough to hold its ground in most of the other cases. Generic makers have continually harped on the of lack of affordability of lifesaving medicines to justify their ‘low-cost versions’ before the court. Roche's encounter with Cipla on the anticancer drug erlotinib (Tarceva) and Ranbaxy and others on anti-viral valgancyclovir hydrochloride (Valcyte) patents are examples. Cases against Natco Pharma, Dr Reddy's, Glenmark, and others are ongoing.

Change Of Heart
What led to the surprising change of heart that prompted Roche to give away its high profile, tech-intensive patented products to a generic firm in the very same country the company is waging a patent crusade?

Analysts deem it a deft move with far-reaching ramifications for the industry. Obviously, Roche wants to have clear control over the generics of its products. By authorizing one CMO, the company may deter other potential generic makers. Usually, competition from multiple players is the norm in India, particularly for blockbusters. It's a smart move, on that count.

But the implications of the deal go well beyond having a profound say on biosimilars in India. In one way, the tie-up with Emcure could be an indicator that Roche is making a foray into the generics domain, where the company is yet to leave a footprint. Companies from the big pharma arena (including Roche’s cross-town rival Novartis) are striving to build  full-fledged generic portfolios.

Also, the Roche-Emcure alliance comes at an opportune time. All the crucial markets have started accepting copycats of complex Biologic substances. Countries like the U.S. are on the verge of finalizing a roadmap towards that end.

For Roche, India would be a test market for generics before taking them to developing and mature markets. Both Herceptin and MabThera are expected to lose patent protection and fall into the generic domain in the next several years. There is enough indication that a few other firms have also started working on biosimilars of these large-selling medicines. So the first plunge in the world’s hub of generics will be the litmus test.

Takeaways For CMOs
Roche has already hinted that the pact with Emcure could be expanded to include other products as well, in days to come, according to published reports. The biggest takeaway, however, for the Indian CMOs is that Roche’s deal is a loud endorsement of their prowess in tech-intensive biologics, yet to get recognized worldwide. Several companies have reportedly developed the know-how and capabilities to commercially produce a range of BIO -drugs, including monoclonals. And a few have made long-term supply pacts with world's leading drug makers. But a collaboration to make biosimilars of on-patent drugs with an Indian company is considered the first of its kind. The deal will help Emcure to hone skill-sets to produce more advanced monoclonals, experts said.

Monoclonals are one of the leading segments in the emerging biosimilars market, which is forecast to rise to the level of $17 billion by 2020, with more high-value biologics coming off patent, according to a Datamonitor February 2011 report. Having mastered most of the first-generation biologics, Indian companies have already grabbed on to advanced biologics. Dr Reddy's launched biosimilars darbepoetin, rituximab, filgrastim and pegfilgrastim. Avesthagen is close to launch its darbepoetin in association with Malaysia's Inno Biologics. Intas Bio, which has already launched peg-GCSF, Epo, IFN, etc. is building a huge facility for MAbs at Sanand in Gujarat. Cipla has announced that it is working on biosimilars of Avastin, Enbrel and Herceptin after making substantial investments in two bio firms.

So, let’s watch how the new deal could open up new avenues for these and other leading players in the market, including Zydus Cadila, Wockhardt, Reliance Life, Biocon and Ranbaxy.

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S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.