After years of waiting, Indian biotech companies can launch their generic biotech drugs (biogenerics or copycat biotech medicines) in the US when it opens up the $10-billion market by 2010 through a new bill. The opportunity is big, considering that the Indian biopharma industry had revenues of just $1.72 billion (Rs 6,899 crore) in 2007-08.
A legislation?The Bipartisan Biogenerics Consensus Bill: Promoting Innovation and Access to Life-Saving Medicine Act? proposed by Rep. Henry A. Waxman and other House members on Wednesday would give the US Food & Drug Administration the authority to approve copycat versions of biotech drugs. Waxman, who is also credited with an existing legislation on pharma generics to his name (the Hatch-Waxman Act of 1984), will introduce the follow-on biologics bill in the 111th Congress. USFDA approvals to generic pharma drugs are based on the Hatch-Waxman Act.
If the bill goes through, Indian companies can then develop their biotech drug programmes in sync with the new guidelines, and reap a share of the growing US market. Companies like Biocon, Bharat Biotech, Dr Reddy?s Labs, Shantha Biotechnics and Wockhardt have been selling various biotech drugs in India for diseases like cancer and diabetes, and are keen to sell these in the US.
Kiran Mazumdar-Shaw, chairman & MD of Biocon, told FE , ?This is a landmark announcement, which paves the regulatory path for generic biologics. This will certainly see the advent of biogenerics over the next 12-24 months. All our programmes can now be developed along the new guidelines that the US will announce for biogenerics.?
?Until now, there was no clear regulatory path for biogenerics. Now, the guidelines will make it possible to launch biogenerics through abbreviated clinical development pathways where generic companies will be able to use innnovator?s data to conduct abbreviated (shorter) clinical trials in order to enter the market,? Shaw said. ?We are already half way down the process of registering insulin in the US that now becomes far clearer in terms of what needs to be done,? she added.
Insulin would be the first biogeneric of Biocon to enter the US market, by early 2011. Biocon has a growing pipeline of biogenerics, including insulin analogs, GCSF and monoclonal antibodies.
The new bill is significant in two ways. First, in the absence of clear norms to regulate the sales & marketing of generic medicines derived through biological methods, no generic company could launch its biotech drugs in the US.
According to Frost & Sullivan, the biosimilars (biogenerics) markets in Europe and USA together have the potential to generate sales of $16.4 billion by 2011, at an average annual growth rate of 69.8%.
Second, the new bill gives more breathing space for generic drug-makers, by giving the innovative companies or the makers of the ?original? drug only five years of exclusivity period?the period in which the data of the drug in question will remain in the exclusive domain of the originator. The possibility of a three-year extension in certain cases has been allowed. The demand of innovative companies was for an exclusivity period of 14 years.
Shrikumar Suryanarayan, director-general, Association of Biotechnology Led Enterprises of India, said, ?The clarity on substitutability will help biogeneric players who do not have sufficient marketing as well as financial powers to compete with MNC majors, as pharmacists can substitute a high-priced biotech drug with cheaper branded generic without a physician?s prescription.?
For instance, Wockhardt, a pharma company, has a biotech division and has six biogenerics in the Indian market. Its pipeline includes an insulin generic. Dr Reddy?s currently markets biogenerics like Reditux, a version of Roche?s blockbuster rituximab monoclonal against non-Hodgkins lymphoma; and Grafeel, a version of G-CSF. Dr Reddy?s announced in mid-2007 that it planned to invest $20 million to expand its biogenerics capability.
