Regulatory challenges
Despite World Trade Organization membership and recent improvements in compliance with international regulatory and intellectual
property laws, there remains no formal regulatory framework for follow-on biologics in India or China. "The market is highly
fragmented and the many shifts in regulation have made it worse," says Shaw. "However, the opening up of the US market should
drive growth in the sector.''
Currently, Asia is the primary market for follow-on biologics, accounting for 34.1% of global sales, according to a new report
by Markets & Markets on Biosimilars (2009–2014), but the US market is predicted to rise to the top spot once a regulatory
pathway for follow-on biologics approval is passed (At press time, several proposals were routing through the US Congress).
According to the report, the sector is poised to be worth $19.4 billion by 2014 globally, by which time the US would have
overtaken Asia as the dominant market.
Several follow-on biologic companies such as Biocon, Dr. Reddy's Laboratories (Hyderabad), Reliance LifeSciences (Mumbai),
the Indian operation of San doz (Mumbai), Teva (Mumbai), and Wockhardt (Mumbai), are chaffing at the bit at the shifts in
regulation. These firms have been marketing their drugs in India, China, and Europe for several years. Europe, which incorporated
a regulatory approval pathway for follow-on biologics in 2004, has approved nine products to date.
The scientific and regulatory experiences with these products suggests that these firms are poised to dominate the US market
after legislation permitting approval and sale of follow-on biologics is completed. "We would certainly like to have a first-mover
advantage in the USA, as soon as the country opens its market for biogenerics,'' adds Pankaj Patel, CEO of the Zydus Cadila
Group (Ahmedabad).
Zydus is developing follow-on therapeutic proteins and new biological entities, including monoclonal antibodies (mAbs), at
its research center in Ahmedabad. Patel added that it is becoming increasingly apparent that "only large, well-capitalized
companies with sophisticated regulatory, marketing, and distribution capabilities will be able to compete in the US follow-on
biologics market. Several Indian companies fit the bill.'' Zydus's current follow-on biologic portfolio includes ESAs, interferons,
insulin, growth factors, pegylated proteins, and mAbs.
Maintaining a lead
Table I: Select Indian pharmaceutical firms with follow-on biologics.
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By 2015, follow-on biologic erythropoietins are expected to emerge as the dominant type of drug product around the world and
achieve sales of $6.1 billion; close behind will be recombinant non-glycosylated protein products, which currently account
for 61% of the global follow-on biologics market, according to the Markets & Markets report. Together, these products would
help the global sector grow to $11.5 billion in sales, by 2015, according to the report. Indian firms, who already market
erythropoietin drugs, are clearly in an advantageous position (see Table I).
Indian companies are taking on new vaccine-development challenges as well to maintain their edge in the biopharmaceutical
sector. Some novel homegrown products in late-stage development include a single or combination vaccine against locally relevant
diseases such as Japanese encephalitis and anthrax, cholera, and meningitis, manufactured by biopharmaceutical companies Panacea
Biotec, Biological E (Hyderabad), and Transgene Biotek (Medak District, Andhra Pradesh), respectively, and a vaccine against
rotaviral diarrhea (Bharat Biotech International, Hyderabad). Novel products such as bacteriophages as antibacterial agents
against multidrug resistant bacteria and lysostaphin, an anti-infective multidrug resistant to Staphylococcus aureus, are also being developed in India.
To maintain a leadership position in follow-on biologics, Indian pharmaceutical and biotechnology companies are forming new
alliances with the government-funded Department of Biotechnology, publicly funded institutions, and global philanthropic institutions
such as the PATH Malaria Vaccine Initiative (a grantee of the Bill & Melinda Gates Foundation,) and the Wellcome Trust in
the United Kingdom. The potential for further growth in follow-on biologics is huge, and Indian firms are solidifying their
share of the pie.
A. Nair is a freelance writer based in Mumbai.
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