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Biosimilar Pioneers Play Their Strategy Cards Close to Vest

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By Lynn Yoffee
Executive Editor

SAN FRANCISCO – With an established reputation for its generic drugs, Mumbai, India-based Lupin Ltd. has expanded into biosimilars in its quest to become a global biopharma powerhouse. But like the foggy view from the 32nd-floor penthouse location of the Asia track at the J.P. Morgan Healthcare Conference Wednesday morning, the firm's chief financial officer provided limited insight into the company's biosimilars strategy despite audience questions.

The same held true for another biosimilars developer: South Korea's Samsung Biologic's President and CEO Tae-Han Kim revealed few details of his company's biosimilars portfolio.

It's a clear sign of the immense challenges faced by 139 companies pioneering this new subindustry with 276 biosimilars in development or already on the market in 31 countries, according to BioWorld's new report: The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies.

Lupin already is deep into biosimilars development. It established a biotech research group in Pune, India, in 2009 to develop and commercialize biosimilars, as well as new biologics. To date, it has racked up an approval for filgrastim (branded as Neupogen by Amgen Inc.) last year in India. It's current pipeline includes a biosimilar of pegfilgrastim, branded as Neulasta – another Amgen original. Both drugs have made billions of dollars for the big biotech and both patents are set to expire in 2015 in Europe and the U.S.

BioWorld's report reveals that Lupin also has eight undisclosed proteins in various stages of early development, but the firm's Ramesh Swaminathan, president of finance and planning, declined to elaborate. "Our pipeline is confidential," he told BioWorld Today.

Though he said the company has 100 products in various stages ready for launch in the "near term," he declined to identify whether biosimilars were part of that list.

But with 5,000 sales reps already established in the U.S., Lupin is ready to roll in a very important market, even though there is no clear regulatory path – yet.

"Going forward, we'd also like to be present in Latin America, Russia and parts of Europe," Swaminathan said. "But the biosimilars pathway for America and Europe is not clear."

Lupin said it would like to partner with a big pharma and offers its services as a manufacturing specialist.

"We're looking for deeper pockets to further develop biosimilars," he said.

An exec in the audience asked Swaminathan why Lupin is targeting those countries given their regulatory "protectionist approaches," and he responded by saying, "We still believe we could succeed in these markets."

Despite the myriad challenges biosimilars development presents, 138 other companies are pursing the hot new space like Lupin, according to BioWorld's report.

Comments from Samsung Biologics' Kim mirrored Swaminathan's: "We don't think biotechs or big pharmas are great at manufacturing, which is where Samsung is concentrating," he said.

Though the 2-year-old company projects $1 .6 billion in annual biosimilar sales by 2020, it stumbled with its first candidate out of the gate. Comparability studies for SAIT 101 – a rituximab biosimilar (branded Rituxan by Biogen Idec Inc. and Roche AG) – in rheumatoid arthritis were temporarily halted at two sites last October. Rituxan is approved for non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis.

Kim declined to provide a status update on those trials.

Samsung Biologics was formed as a joint venture between the Seoul, South Korea-based electronics giant and Quintiles Transnational Corp., of Research Triangle Park, N.C. (See BioWorld Today, March 2, 2011.)

The company is offering both contract development and manufacturing services, and is developing its own biopharmaceuticals and biosimilars. Its new production facility in Incheon, South Korea, is expected to come online the first half of 2013. In addition to its own products, the start-up created a second joint venture with Biogen Idec Inc., of Weston, Mass., to develop a biosimilar portfolio. (See BioWorld Today, Dec. 7, 2011.)

Why would an electronics powerhouse delve into biologics and biosimilars?

"We believe the biopharma market will grow continuously," Kim said. "We're reaching a turning point due to a rising demand for more effective drugs. We see cost and price competition getting heavier. We see need for value chain optimization."

Kim said his company can parlay deep experience in manufacturing to the drug development sector and has plunked down a $2 billion bet, starting with a plant that was constructed in 1.5 years and completed just last month. Construction on a second plant in South Korea already has begun and plans for a third are already on the drawing board, all without a single drug ready to roll.

Samsung isn't denying a lack of experience in the drug development field, though.

"Two-thirds of our senior managers come from the U.S. and Europe with experience in biopharma," he said.

In addition to the 276 potential follow-on biologics/biosimilars in development or already approved, at least 78 undisclosed monoclonal antibody biosimilars are in the pipeline, according to The Biosimilars Game: A Scorecard for Opportunities, Threats and Critical Strategies. The report includes 139 biosimilar company profiles as well as terms for 77 deals involving follow-on biologics/biosimilars.

Editor's note: For a copy of BioWorld's new biosimilars report, please contact the BioWorld Data account managers for exclusive introductory pricing at (800) 477-6307.