Accounting for regulatory delays
Kamal K. Sharma, managing director of Mumbai-based Lupin, says "Once clarity emerges on the regulatory front, especially in
the US, biosimilar drugs could provide a huge potential. However, data exclusivity in the US market [remains] a severe challenge,"
said. The company expects to launch its first follow-on biologic product in India this year.
According to the research firm Nomura Equity Research, between 2008 and 2015, biopharmaceuticals worth $59 billion are set
to lose patent protection globally. From 2012, the follow-on biologics market is expected to add an estimated $10 billion
in incremental revenues each year until 2020. In the US, the Congressional Budget Office recently estimated that potential
savings on biologic drug products in the US between 2009 and 2014 could be as high as $25 billion, once a pathway for approval
and marketing follow-ons is implemented. The fact is, although some of the drugs targeted for follow-on versions have garnered
billions of dollars in sales for the original manufacturers, cashing in for Indian companies would be "no walk in the park,"
says Cipla's Hamied. Much rests on the implementation of the follow-on biologics pathway in the US.
While the US sorts out its implementation plan, some Indian firms are focusing on Europe in the short term. For example, Biocon's
Shaw said the firm is in the process of registering its insulin for the European market and has licensed its G-CSF (granulocyte
colony stimulating factor) to a North American firm and to Abraxis BioScience for the European market. Biocon is in the midst
of setting up a marketing office in London, making Europe its focus during the next 12 months.
Ranjit Kapadia, vice-president of the institutional research firm HDFC Securities in Mumbai, adds that, because the "US law
will take a while to be implemented and could undergo some revisions, Indian companies will not be able to launch their biosimilar
anytime soon. And that is why the Biocon deal with Pfizer makes perfect sense. They have sold the rights to Pfizer. Now, Pfizer
will have to fight to market their biosimilars in the US, whereas the Indian firm can sit pretty."
A. Nair is a freelance writer based in Mumbai.