WASHINGTON - BIO President Jim Greenwood recently returned from a barnstorming trip across India to drum up interest for the BIO India Partnering Conference in September 2010, where he touted India's burgeoning innovative biotech industry and discussed the growing interest of BIO's seeking new or expanded partnerships with Indian firms.
[Editor's note: This story is reprinted from PharmAsia News - Nov. 30, 2009. Not a subscriber? To register for a free trial, click here. Look for part two of this interview in the Dec. 1 issue of PharmAsia News.]
While in India, Greenwood addressed the BioInvest Conference, sponsored by the Association of Biotechnology Led Enterprises (ABLE), BIO's India counterpart.
He reassured the conference and India - with its well-established generics operations - that the U.S. biotech industry will welcome the entry of biosimilars into the U.S. market, though he expects there to be less competition than the traditional generics market because the regulatory barriers will be much higher for biosimilars than other generic drugs (PharmAsia News, Nov. 10, 2009).
Greenwood noted that up to $25 billion worth of innovator biologics will lose patent protection by 2016, and many companies are looking to partner with Indian firms to diversify into the biosimilar segment.
Similarly, Western firms are looking to enhance their vaccine portfolios, and they are increasingly turning to India, which has become the world's largest maker of vaccines. Greenwood pointed to Sanofi-Aventis' dramatic acquisition of Shantha Biotech, which culminated in a bidding war with GlaxoSmithKline. Sanofi ultimately prevailed, giving the company a portfolio of vaccines it considers "greatly adapted to new markets," according to Sanofi CEO Chris Viehbacher (PharmAsia News, Aug. 28, 2009).
Greenwood spoke with PharmAsia News on his return from India about partnering prospects, regulatory concerns and potential roadblocks for India's biotech growth.
PharmAsia News: You met with the Indian Secretary for Pharmaceuticals and with the Minster of Science and Technology. What did you discuss with them?
Jim Greenwood: We were really focused on our upcoming partnering event. That was really the primary purpose of the visit was to promote this upcoming event in September in Hyderabad.
We wanted the Indian government to be aware of the fact that we were doing this. We wanted them to know that we were partnering with ABLE, which is one of the corresponding biotech associations in India, and we wanted to solicit their participation and support. We succeeded in all those things, and they are very supportive of our efforts and interested in participating and encouraging others to participate.
PharmAsia News: You also met with the Organization of Pharmaceutical Producers of India and they were encouraging you to push U.S. FDA to train its counterparts in India. Is that something you will do?
Greenwood: We do think that's a reasonable idea, and we've already spoken to folks about it. Obviously the FDA, with all of its issues and problems, is still the gold standard of the world. The Indian pharmaceutical companies thought there was a lot that the Indian counterpart agency could learn from the FDA, which has obviously been around a bit longer. We think it's a good idea. It helps with harmonization, and it might enable the Indians to leapfrog over some mistakes and practices that we evolved over time.
PharmAsia News: Does BIO intend to increase its lobbying efforts in India?
Greenwood: In the recent couple of years, we created an international department here at BIO. We've always had our department of federal government relations and state government relations, and we recently created the international effort. We are doing that already. One of the ways we do that is we partner with all of our sister associations around the globe so that when we want to weigh in on the WTO or WHO or some other international organization we try to do it literally with a letter signed by as many of these other organizations as possible to demonstrate that this is not just a U.S. point of view but that it's a widely held point of view globally.
When we do these partnering events, and of course we do them in the U.S. and have for a long time, we do two a year in Europe, one in Japan, and now we will begin to do one annually in India in September and we will begin to do one in China. Eventually we do want them to become opportunities for advocacy.
By bringing together this international biotech community, you tend to attract the policymakers that either want to be there to learn about the industry and partnering opportunities or to be seen themselves politically, to do some networking themselves. And that gives us an opportunity for us to expose them to some of the issue controversies that the industry faces, and gives us the opportunity to try to enlist their support and maximize the policy environment in a place like India to benefit its own domestic industry as well as the international industry.
PharmAsia News: What are some of the specific issues that you're concerned about in India?
Greenwood: Historically it's always been about intellectual property protection in India. I would quickly add that India has made some significant strides in that regard. They have improved their ability and their willingness to protect intellectual property, [but] they have further to go.
They don't allow the patenting of certain kinds of entities that we do, and we think that should be with the international standard. I made that clear in my remarks at the convention where I spoke in Mumbai. [Editor's note: BIO later clarified that India, unlike the U.S., does not allow patents on microorganisms, plants and animals that have been modified through genetic engineering or selective breeding.]
PharmAsia News: Are you satisfied with their progress?
Greenwood: We're never going to be satisfied until we think it's maximally conducive, and it's not just about American operators in India, but it's about the Indian innovative enterprise itself. We also recognize that cultures are different, traditions are different, and politics are different, so we don't want to be overly aggressive about it.
When we speak on this issue, we speak with our Indian counterparts with one voice. There's not a difference of opinion between U.S. and Indian companies that I'm aware of on the issue of IP.
PharmAsia News: How would you characterize India's capability to produce biosimilars?
Greenwood: The strength of the Indian biopharma sector has been in the so-called generic or biosimilar side of things. … I think where the Indian industry wants to make more progress is in its innovative capacities.
- Daniel Poppy (d.poppy@elsevier.com)
