MUMBAI - Prospects for strong growth in the global generic biologics space in the next 10 years has brought together the world's third-largest generic drug maker Mylan and India's biotechnology company Biocon. The two signed a comprehensive deal that will share development and certain other costs to bring biologic drugs to the market.

Through the deal, Mylan will have exclusive commercialization rights in the U.S., Canada, Japan, Australia and New Zealand while a profit-sharing agreement has been worked out with Biocon for the European markets.

"The complexity and costs involving in developing generic biologics are expected to see only a few players being able to gain entry into the highly regulated markets of Europe and USA," an executive at Biocon said. "Bio-generics in the emerging markets are expected to grow from the current estimate of $1.5 billion at a projected rate of 20 percent per annum over the next five years."

Mylan CEO Robert J. Coury said, "The unique collaboration combines Biocon's scientific expertise, excellent product development track record, cost-efficient and scalable biologics manufacturing with Mylan's one-of-a-kind global commercial footprint and regulatory expertise around the world."

"Generic biologics, especially monoclonal antibodies, are set to become the next great bolus of growth in the generic pharmaceutical industry, and through this alliance, Mylan and Biocon have covered all corners of what any organization would want or need to have secured to offer a highly competitive and distinct generic biologics product portfolio with tremendous growth potential for the coming decade," Coury added.

Biocon Chairperson Kiran Mazumdar Shaw said that mABs are fast emerging as the most dominant class of biologics.

Some analysts have estimated that biologics worth $25 billion are set to lose patent protection by 2016, creating a significant market opportunity for protein therapeutics like insulin and its analogs, erythropoietin, human growth hormone and mABs.

One analyst with an Indian investment firm said, "The deal is complimentary to both the parties. Mylan gets a strong partner in the generic biologic space and Biocon will gain from the shared cost structures and global presence of Mylan."

An industry expert said the deal was essential for Mylan as its top rivals Teva and Sandoz both have a sizeable portfolio of generic biologics. "Future growth will be fuelled by those drugs and that segment can hardly be ignored," a veteran industry source told PharmAsia News.

Biocon CEO Arun Chandavarkar told PharmAsia News that his company will mostly target difficult-to-copy mABs and will not chase every biological drug that goes off-patent.

"For some semi-regulated markets, the two companies will make an early entry, while for the rest, the time for regulatory clearances will be much longer," he said.

Chandavarkar declined to disclose the drugs involved in the deal or its financial aspects, but said the cost for developing those molecules will be significantly high and both Biocon and Mylan realize that taking them to the market independently may be a tough task.

For the U.S. market, Biocon has already tied up with Abraxis for development and commercialization of a generic form of GCSF and with another, undisclosed company for insulin products.

Biocon is also building an innovative research pipeline and has been scouting for licensing deals for two if its drug candidates (PharmAsia News, Dec. 15, 2008).

- Vikas Dandekar (v.dandekar@elsevier.com)

Biologics Beckon: Biocon, Mylan Strike Deal; Combine To Take Teva, Sandoz Head-on

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