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Oncobiologics, Zhejiang Huahai Form Global Alliance

oncobiologics_bwt05092013

By Catherine Shaffer
Staff Writer

Oncobiologics Inc. allied with Zhejiang Huahai Pharmaceutical Co. Ltd. to develop, manufacture and commercialize biosimilar monoclonal antibody products equivalent to Humira, Rituxan, Avastin and Herceptin in a rapidly expanding subsector which has reached $2.4 billion – a 20 percent increase from 2012.

The products will be commercialized by Huahai and manufactured in China at a Huahai biologics facility for the China market. The companies will also establish a co-development and commercialization partnership for launching biosimilars in 30 developed countries including the U.S., EU, Japan, Canada and Australia.

"This is a significant deal for both companies," Pankaj Mohan, founder and CEO of Oncobiologics told BioWorld Today. "Huahai is a small-molecule, medium-sized generic company with over $500 million in revenue."

Mohan said Huahai, of Linhai, China, is moving into biologics, and had been looking to partner with a small biotech company, and that for Oncobiologics, partnering with a midsized generics company would "really help us launch our biosimilars" as well as providing financial support for the company.

The partnership has two key elements, according to Mohan. Oncobiologics, of Cranbury, N.J., will provide Huahai with biologics capability, helping it to ramp up in the areas of clinical manufacturing and commercial manufacturing. Second, Huahai will become an anchor partner for Oncobiologics with a joint venture in the U.S. for development and commercialization of the four biosimilars.

Mohan said that Oncobiologics was approached by multiple Chinese pharma companies. "We were looking for a company that has quality at its heart," he said. "Huahai is very well known and very well respected."

Huahai was the first Chinese company to distribute a small molecule product in the U.S. "They are progressive and at the same time very quality conscious," Mohan said.

The Chinese biosimilars market has many players. "The advantage Huahai has in China is that these products we're talking about would be developed to U.S. and EU standards," Mohan said, but the cost of manufacturing would be similar to Chinese local manufacturing.

Oncobiologics said that the global annual revenue from all four biologics together is more than $40 billion with more than $20 billion in the countries covered by the agreement. Mohan said that Humira revenues are $9.5 billion, and will reach $11 billion to 12 billion by the time the patent expires.

"These are critical drugs that are coming off patent soon," Mohan said. "At the same time they are very difficult to copy." That means that in terms of competition in developed country markets, the critical factor will not be how many players are developing biosimilars, but how many can get it approved in those regulated markets.

That's proving to be a challenge. Mohan noted that a number of companies have had problems getting biosimilars to the finish line.

Korean company Samsung BioLogics Co. Ltd. temporarily halted an EU comparability study of its rituximab biosimilar at sites in Spain and the Czech Republic last year. The trial is ongoing at three other European sites, according to the EU trial registry. Also last year, Teva Pharmaceutical Industries Ltd. suspended plans for a U.S. Phase III trial of its rituximab biosimilar, being developed through a joint venture with Lonza Group AG. Citing "changes in the regulatory and competitive environment," Teva said it needed to reassess its development plan for TL011. (See BioWorld Today, Oct. 9, 2012.)

As well, Celltrion Inc. halted a late-stage trial of a rituximab biosimilar for undisclosed reasons. (See BioWorld today, April 19, 2013.)

The latest BioWorld Data report, The Biosimilars Game: A Scorecard for Opportunities, Threats, and Clinical Strategies, identified 27 companies with rituximab biosimilars in their pipelines, and shortly after the report was released, Amgen Inc. revealed that it also was developing a rituximab copy through its partnership with Actavis Inc. (See BioWorld Today, Jan. 29, 2013.)

Biosimilars Market Set to Explode

According to a new study by British market research firm Visiongain, the global biosimilars market will be worth nearly $2.5 billion this year, an increase of 20 percent over 2012, and would account for 2 percent of the overall market for biologics.

That market is poised to expand rapidly through 2023 with biosimilars hitting the market in the U.S. and European Union, growing fastest for monoclonal antibodies and insulins.

Rimsima, a biosimilar of Remicade (infliximab, Johnson and Johnson), and a biosimilar version of Herceptin (trastuzumab, Roche AG), by Celltrion Inc. and Hospira Inc. were approved in the European Union last year and are expected to launch there next year. At the same time, biosimilar versions of erythropoietin and filgrastim products are expected to drive biosimilar growth in the U.S.