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BW Businessworld

A Bit Too Early To Cheer

Photo Credit :

have spent huge sums on biosimilars R&D
(Pic by Amit Verma)

A bipartisan law, “The promoting access to Life-Saving Medicine Act,” was introduced in the US House of Representatives on 11 March. The law, which seeks to pave the way for the launch of biosimilars — cheaper copies of biotech medicines — has got the US generics industry excited. Such a law has been eagerly awaited by Indian companies such as Dr. Reddy’s, Biocon, Intas Biopharmaceuticals and Wockhardt, which have invested crores in research, development and manufacturing of biosimilars. The western markets are the most sought-after destination for biosimilars.

“The bill will see the advent of biogenerics over the next 12 to 24 months,” said Kiran Mazumdar-Shaw, chairman and managing director of Biocon, to a newspaper. Yet, it is too early to herald the arrival of Indian biosimilars on US shores. There could be competing bills with support cutting across party lines. For instance, the Pathway for Biosimilars Act, is expected to be reintroduced soon by other House members. This bill seems to weigh in on the side of innovators who have systematically lobbied against biosimilars and blocked their entry.

But even if legislation gets through, firms will have to jump through several hoops held out by the US Food & Drug Administration. Take the case of Europe, which approved its first biosimilar in 2006. Over 10 such products were approved in three years from the likes of Israel’s Teva and Germany’s Sandoz. Indian firms have yet to get their foot in the door.


The new US bill seeks to:
Empower the US drug regulator to
approve a biosimilar and decide if
it is interchangeable with the
innovator drug on a case-by-case basis

Provide a mechanism to effectively
resolve patent disputes between
innovators’ drugs and biosimilars
and prevent frivolous lawsuits

Curb market and data exclusivity
to innovators that extend
their monopoly

Source: Generic Pharmaceutical
Association, USA

“It is a fairly long process (to get approval) in the developed markets,” says Dhananjay Patankar, chief technical officer at Intas Biopharma, which is testing a biosimilar. “It can take five years from the time that you have a product on your hands.”

The reason: in Europe, biosimilars, made using living organisms such as bacteria and yeast cells, require far more elaborate tests than chemical generics to demonstrate their similarity to innovator products. Where vanilla generics are tested on tens of patients over weeks, biosimilars are being tested on hundreds over months. The cost difference is in millions of dollars. Unlike generics, the approval process requires companies to constantly consult with the regulator and modify their planned trial, if need be.

“It is unlikely that US regulations will be more generous than Europe’s,” says Patankar. There is also the question of ‘switchability’, says Dinesh Dua, CEO of Chandigarh-based Nectar Life Sciences. A pharmacy cannot switch a prescribed brand with a cheaper biosimilar, the way it does with chemical generics. This means convincing doctors to prescribe — best achieved with a strong marketing partner who has demonstrated leadership in this area. Indian biosimilars have hardly announced such alliances.

More than any legislation, one key indicator that India’s planned biosimilars foray into the West is gaining traction would be if Indian firms strike more partnerships that take the cost of seeking approval off their books, and provide them marketing leverage. There is opportunity: in addition to generics firms, western drug makers such as Merck, AstraZeneca and Eli Lilly are also now interested in the biosimilars opportunity. It is time for action.

(Businessworld Issue Dated 24-30 March 2009)