Biotechnology can be the next big driver for the pharma sector

The coming together of Biocon and Mylan for a biogenerics entry coincided with a study done by EvaluatePharma that predicted at least six biotechnology drugs will have blockbuster status in the next five years, that is, 2014.

The study said 5 out of the top 10 drugs would be antibodies, 3 of which are
specifically anti-cancer agents, illustrating the importance of this technology to the industry. The study lobbies for the recognition of the biotechnology industry. The sector is now bearing the fruits of decades of hard work, which for the most part, generated limited success.

The top ranking product will be breast cancer drug Avastin, despite its recent setbacks on lifecycle management issues. The drug, said to be one of its kind, will generate revenues of over $9.23 billion, replacing Lipitor by a good margin.

The authors of the study noted, “The fact that a biotech product will assume Lipitor’s crown in 2012, after the cholesterol-lowering drug phenomenon goes off patent, is indicative of the increasing dominance of biotech products, and specifically cancer antibodies.”

Following Avastin will be the monoclonal antibody from Abbott and Eisai, branded Humira, with expected sales of $9.1 billion. Humira, an anti-rheumatic, could even claim the number one spot if Avastin gives negative results in its follow-up researches. Rituxan from Roche and Genentech will continue its success march and be positioned as the third-largest drug with sales of $7 billion plus.

Interestingly, the fast-growing insulin brand Lantus, from Sanofi-Aventis, could be the fifth-largest drug after Enbrel from Amgen, Takeda and Wyeth with sales swelling to $6 billion up from the present $2 billion. It, however, depends on how the drug emerges from the current studies that linked Lantus with malignancies.

As a result of this expected change in the world drugs market, top brands such as Lipitor, Plavix and Advair will move down the charts. Companies will lose their star brands and therefore, are reworking their business and research priorities to get the maximum bang for their bucks.

The analysis by EvaluatePharma also reveals that biotech drugs will account for 50% of the top 100 drugs in 2014, compared with just 28% last year and 11% in 2000. The sector, which so far had been neglected by Big Pharma on the pretext that it sucks huge amounts of capital, is set for the glory it rightfully deserves.

How is the Indian pharmaceutical industry linked to this metamorphosis?  Mainly through biosimilars.

The study by EvaluatePharma said, “Although the patent life for a majority of these blockbuster biotech products extends well beyond the current patent cliff for conventional drugs, these facts illustrate the huge significance of the ongoing debate over a regulatory pathway for biosimilars in the US.”

The alliance that Mylan struck with Biocon could be a trendsetter. Mylan had to match its peers — Sandoz and Teva — to gear up for the biosimilars opportunity. Teva has its Tevagrastim launched in Europe and Sandoz has three drugs — erythropoietin, growth hormone and filgrastim — in the same market. Sandoz has also entered the US through a one-off rule with its growth hormone.

It will become compulsory for every Indian company to have a plan for biosimilars. There seems to be too much crowding from multinational companies but alliances such as the one between Mylan and Biocon could show the way. A conventional protein takes no less that $500-100 million for development and that cost can be proportionately shared by two like-minded companies.

Indian biotech capabilities are being recognised throughout the world. Intas Biopharma is establishing its presence and there is news of Shantha Biotech being on GlaxoSmithKline’s radar. Wockhardt, minus its financial mess, is one of the best players in the industry. Watch out for a sizeable deal there in the future.

Dr Reddy’s Laboratories is a visionary company that has seen opportunities before others and is already developing a pipeline of monoclonal antibodies.

After leading in the generic drugs space for over 10 years, it is time for Indian biotech companies to shift gear — collaborate with Big Pharma to tap the next boom opportunity. The ones who are left behind will die a natural death, conforming to Darwin’s words.

Pillman is an executive closely linked to the global pharma industry.