The bioequivalence issue in the US is awaiting legislation that would amend Sec. 262 of the Public Health Service Act. Major
healthcare legislation is unlikely in 2008, an election year, and passage of a standalone biogenerics bill is also unlikely,
given the opposition by the Pharmaceutical Research and Manufacturers of America and other lobbying groups for innovator biotech
companies.7 In late 2005, the EMEA gave final approval to basic guidelines for Similar Biological Medicinal Products.8 Since then, it has approved two growth hormone biosimilars, Sandoz's Omnitrope and Biopart-ners' Valtropin, in early 2006,
as well as Sandoz's EPO biosimilar in August 2007.
The opening up of the European biosimilars market marks the end of the beginning of the biogenerics industry. Products made
by India's biogenerics makers or their Western licensees will appear in European pharmacies as soon as their abbreviated clinical
research requirements and EMEA reviews are completed successfully. Biogenerics will ultimately take, and keep, a significant
chunk of the global biotherapeutics market, as biotherapeutics themselves take a larger portion of the global pharmaceuticals
But in the near term, the biosimilars market isn't as appealing as it might seem. The lack of US legislative action so far,
the unlikelihood of action any time soon, and the evident opposition to such legislation, reduces the available market. And
it is far from clear that when such legislation is enacted, it will include terms that make the follow-on biologics market
attractive for India's generics makers.
Even in the European biosimilars market there is room for skepticism. Two of the first three approved biosimilars are competing
against each other, and the more popular one of the two, Sandoz's Omnitrope, has so far captured less than 1% of the European
HGH market, despite being priced up to 25% lower than the drug it was made to resemble, Pfizer's Genotropin.9
For Indian companies, a smaller piece of the pie may still be enough to justify their efforts. But some may elect to license
development and marketing in Western markets to Western partners—as Biocon already has done for its G-CSF biogeneric—in advance
of approval. And as Biocon's evolution also has shown, biogenerics may represent only a passing phase for some Indian biotech
companies, who prefer to focus their R&D efforts on the creation of new and patentable biologics. Indeed, the same national
pride that makes Indians want to excel at IT and biotechnology seems to make some of them anxious to outgrow the country's
"cheap generics" reputation. Dr. Swati A. Piramal, director of an R&D center for Nicholas Piramal in Mumbai, was quoted not
long ago as saying, "Indian companies are no longer going to be just copycats. We want to take our rightful place at the head
table with the developed nations."10
Eric Langer is president and managing partner at BioPlan Associates, Inc., Rockville, MD, 301.921.9074. firstname.lastname@example.org
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4. Curing India: Biocon Takes on Cancer and Diabetes. Fortune: 2006 Oct 2.
5. Dr. Reddy's scripts plan for biogenerics thrust.
http://Rediff.com/. 2001 Jul 24. Acc-essed 2007 Nov 24.
6. Kumar A. Biogeneric Manufacturing in India. In: Langer E, editor. Advances in Biopharmaceutical Technology in India. Gaithersburg,
MD: Bioplan; Feb 2008.
7. Perrone M. Generic Biotech Agreement Proves Elusive. AP 2007 Sept 20. Accessed 2007 Nov 24.
8. European Commission (Enterprise Directorate General). EMEA Guideilne on Similar Biological Medicinal Products. Brussels,
Belgium: 2005 Oct.
9. Biosimilars: How Strong a Market? Accessed 2007 Nov 24.
10. India: Bigger Pharma. Businessweek: 2005 Apr 18.